ORDIN   Nr. 356 din 31 martie 2004

privind aprobarea Listei cuprinzand standardele romane care adopta standarde europene armonizate ale caror prevederi se refera la dispozitive medicale

ACT EMIS DE: MINISTERUL SANATATII

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 326 din 15 aprilie 2004

    Avand in vedere prevederile art. 12 alin. (1) din Hotararea Guvernului nr. 190/2003 privind stabilirea conditiilor de introducere pe piata si de utilizare a dispozitivelor medicale,
    vazand Referatul de aprobare al Directiei generale farmaceutice, inspectia de farmacie si aparatura medicala cu nr. OB 3.719/2004,
    in temeiul Hotararii Guvernului nr. 743/2003 privind organizarea si functionarea Ministerului Sanatatii, cu modificarile ulterioare,

    ministrul sanatatii emite urmatorul ordin:

    Art. 1
    Se aproba Lista cuprinzand standardele romane care adopta standarde europene armonizate ale caror prevederi se refera la dispozitive medicale si ale caror referinte au fost publicate in Jurnalul Oficial al Uniunii Europene, prevazuta in anexa*) care face parte integranta din prezentul ordin.
------------
    *) Anexa este reprodusa in facsimil.

    Art. 2
    Prezentul ordin va fi publicat in Monitorul Oficial al Romaniei, Partea I.

                               Ministrul sanatatii,
                                 Ovidiu Brinzan

    ANEXA 1

                                  LISTA
cuprinzand standardele romane care adopta standarde europene armonizate ale caror prevederi se refera la dispozitive medicale

(prezenta lista adopta standardele europene armonizate aplicabile Directivei 93/42/EEC, ale caror referinte au fost publicate in Jurnalul Oficial al Uniunii Europene)

 ______________________________________________________________________________
|Nr. |   Numarul de referinta  |               Titlul standardului             |
|crt.|                         |                                               |
|____|_________________________|_______________________________________________|
|  1.| SR EN 1041:2003         | Informatii furnizate de producatori impreuna  |
|    |                         | cu dispozitivele medicale                     |
|____|_________________________|_______________________________________________|
|  2.| SR EN 1060-1:2003       | Tensiometre neinvazive. Partea 1: Cerinte     |
|    |                         | generale                                      |
|____|_________________________|_______________________________________________|
|  3.| SR EN 1060-1:2003/      | Tensiometre neinvazive. Partea 1: Cerinte     |
|    | A1:2003                 | generale                                      |
|____|_________________________|_______________________________________________|
|  4.| SR EN 1060-2:2003       | Tensiometre neinvazive. Partea 2: Cerinte     |
|    |                         | suplimentare pentru tensiometrele mecanice    |
|____|_________________________|_______________________________________________|
|  5.| SR EN 1060-3:2003       | Tensiometre neinvazive. Partea 3: Cerinte     |
|    |                         | suplimentare pentru sistemele electromagnetice|
|    |                         | de masurare a presiunii sanguine              |
|____|_________________________|_______________________________________________|
|  6.| SR EN 1089-3:2003       | Butelii transportabile de gaz. Identificarea  |
|    |                         | buteliilor de gaz.  Partea 3: Codul culorilor |
|____|_________________________|_______________________________________________|
|  7.| SR EN 1089-3:2003/      | Butelii transportabile de gaz. Identificarea  |
|    | A1:2003                 | buteliilor de gaz.  Partea 3: Codul culorilor |
|____|_________________________|_______________________________________________|
|  8.| SR EN 1174-1:1999       | Sterilizarea dispozitivelor medicale.         |
|    |                         | Estimarea populatiei de microorganisme pe     |
|    |                         | produs. Partea 1: Cerinte                     |
|____|_________________________|_______________________________________________|
|  9.| SR EN 1174-2:1999       | Sterilizarea dispozitivelor medicale.         |
|    |                         | Estimarea populatiei de microorganisme pe     |
|    |                         | produs. Partea 2: Ghid                        |
|____|_________________________|_______________________________________________|
| 10.| SR EN 1174-3:1999       | Sterilizarea dispozitivelor medicale.         |
|    |                         | Estimarea populatiei de microorganisme pe     |
|    |                         | produs. Partea 3: Ghid pentru metodele de     |
|    |                         | validare a tehnicilor microbiologice          |
|____|_________________________|_______________________________________________|
| 11.| SR EN 12006-1:2003      | Implanturi chirurgicale neactive. Cerinte     |
|    |                         | specifice pentru implanturi cardiace si       |
|    |                         | vasculare. Partea 1: Proteze pentru valve     |
|    |                         | cardiace                                      |
|____|_________________________|_______________________________________________|
| 12.| SR EN 12006-2:2000      | Implanturi chirurgicale neactive. Cerinte     |
|    |                         | particulare pentru implanturi cardiace si     |
|    |                         | vasculare. Partea 2: Proteze vasculare care   |
|    |                         | cuprind conducte pentru valve                 |
|____|_________________________|_______________________________________________|
| 13.| SR EN 12006-3:2000      | Implanturi chirurgicale neactive. Cerinte     |
|    |                         | particulare pentru implanturi cardiace si     |
|    |                         | vasculare. Partea 3: Dispozitive endovasculare|
|____|_________________________|_______________________________________________|
| 14.| SR EN 12010:2001        | Implanturi chirurgicale neactive. Proteze ale |
|    |                         | articulatiei. Cerinte particulare             |
|____|_________________________|_______________________________________________|
| 15.| SR EN 12011:2000        | Instrumentar utilizat in asociere cu          |
|    |                         | implanturi chirurgicale neactive. Cerinte     |
|    |                         | generale                                      |
|____|_________________________|_______________________________________________|
| 16.| SR EN 12180:2002        | Implanturi chirurgicale neactive.             |
|    |                         | Implanturi pentru morfologia corpului. Cerinte|
|    |                         | specifice pentru implanturi mamare            |
|____|_________________________|_______________________________________________|
| 17.| SR EN 12182:2003        | Mijloace tehnice ajutatoare pentru persoane   |
|    |                         | invalide. Cerinte generate si metode de       |
|    |                         | verificare                                    |
|____|_________________________|_______________________________________________|
| 18.| SR EN 12183:2003        | Fotolii rulante propulsate manual. Cerinte si |
|    |                         | metode de incercare                           |
|____|_________________________|_______________________________________________|
| 19.| SR EN 12184:2003        | Fotolii rulante actionate electric, scutere   |
|    |                         | si alimentatoarele lor. Cerinte si metode de  |
|    |                         | verificare                                    |
|____|_________________________|_______________________________________________|
| 20.| SR EN 12218:2003        | Sisteme de sine pentru sustinerea             |
|    |                         | echipamentelor medicale                       |
|____|_________________________|_______________________________________________|
| 21.| SR EN 12218:2003/A1:2003| Sisteme de sine pentru suportul echipamentelor|
|    |                         | medicale                                      |
|____|_________________________|_______________________________________________|
| 22.| SR EN 12322:2003/A1:2003| Dispozitive medicale de diagnostic in vitro.  |
|    |                         | Mediu de cultura pentru microbiologie.        |
|    |                         | Criterii de performanta pentru mediile de     |
|    |                         | cultura                                       |
|____|_________________________|_______________________________________________|
| 23.| SR EN 12342:2003        | Tuburi de respiratie destinate a fi utilizate |
|    |                         | cu aparatura de anestezie si ventilatoare     |
|____|_________________________|_______________________________________________|
| 24.| SR EN 12442-1:2002      | Tesuturi animale si derivatele lor utilizate  |
|    |                         | la fabricarea dispozitivelor medicale.        |
|    |                         | Partea 1: Analiza si managementul riscului    |
|____|_________________________|_______________________________________________|
| 25.| SR EN 12442-2:2002      | Tesuturi animale si derivatele lor utilizate  |
|    |                         | la fabricarea dispozitivelor medicale.        |
|    |                         | Partea 2: Verificari privind sursa, colectarea|
|    |                         | si manevrarea                                 |
|____|_________________________|_______________________________________________|
| 26.| SR EN 12442-3:2002      | Tesuturi animale si derivatele lor utilizate  |
|    |                         | la fabricarea dispozitivelor medicale.        |
|    |                         | Partea 3: Validare a eliminarii si/sau a      |
|    |                         | inactivarii virusilor si agentilor            |
|    |                         | transmisibili                                 |
|____|_________________________|_______________________________________________|
| 27.| SR EN 12470-1:2003      | Termometre medicale. Partea 1: Termometre     |
|    |                         | de sticla cu lichid metalic, cu dispozitiv de |
|    |                         | maxim                                         |
|____|_________________________|_______________________________________________|
| 28.| SR EN 12470-3:2003      | Termometre medicale. Partea 3: Performantele  |
|    |                         | termometrelor electrice compacte (prin        |
|    |                         | comparatie si prin extrapolare) cu dispozitiv |
|    |                         | de maximum                                    |
|____|_________________________|_______________________________________________|
| 29.| SR EN 12470-5:2003      | Termometre medicale. Partea 5: Performantele  |
|    |                         | termometrelor auriculare pe baza de radiatii  |
|    |                         | infrarosii (cu dispozitiv de maxim)           |
|____|_________________________|_______________________________________________|
| 30.| SR EN 12523:2003        | Proteze si orteze externe pentru membre.      |
|    |                         | Cerinte si metode de incercare                |
|____|_________________________|_______________________________________________|
| 31.| SR EN 12563:2000        | Implanturi chirurgicale neactive. Proteze     |
|    |                         | ale articulatiei. Cerinte specifice pentru    |
|    |                         | protezele articulatiei de sold                |
|____|_________________________|_______________________________________________|
| 32.| SR EN 12564:2001        | Implanturi chirurgicale neactive. Proteze ale |
|    |                         | articulatiei. Cerinte specifice pentru        |
|    |                         | protezele articulatiei de genunchi            |
|____|_________________________|_______________________________________________|
| 33.| SR EN 12598:2003        | Monitoare de oxigen pentru amestecuri de gaze |
|    |                         | respiratorii. Cerinte particulare             |
|____|_________________________|_______________________________________________|
| 34.| SR EN 1280-1:2003       | Sisteme de umplere cu agent specific pentru   |
|    |                         | vaporizatoare de anestezie. Partea 1: Sisteme |
|    |                         | de umplere cu clapeta dreptunghiulara         |
|____|_________________________|_______________________________________________|
| 35.| SR EN 1280-1:2003/      | Sisteme de umplere cu agent specific pentru   |
|    | A1:2003                 | vaporizatoare de anestezie. Partea 1: Sisteme |
|    |                         | de umplere cu clapeta dreptunghiulara         |
|____|_________________________|_______________________________________________|
| 36.| SR EN 1281-1:2003       | Echipament de anestezie si respiratie.        |
|    |                         | Racorduri conice. Partea 1: Racorduri mama si |
|    |                         | tata                                          |
|____|_________________________|_______________________________________________|
| 37.| SR EN 1281-1:2003/      | Echipament de anestezie si respiratie.        |
|    | A1:2003                 | Racorduri conice. Partea 1: Racorduri mama si |
|    |                         | tata                                          |
|____|_________________________|_______________________________________________|
| 38.| SR EN 1281-2:2003       | Echipament de anestezie si respiratie.        |
|    |                         | Racorduri conice. Partea 2: Racorduri prin    |
|    |                         | insurubare care suporta greutati              |
|____|_________________________|_______________________________________________|
| 39.| SR EN 1282-1:2003       | Echipamente de anestezie si respiratie.       |
|    |                         | Tuburi de traheostomie. Partea 1: Tuburi      |
|    |                         | pentru adulti                                 |
|____|_________________________|_______________________________________________|
| 40.| SR EN 1282-2:2003       | Tuburi de traheostomie. Partea 2: Tuburi      |
|    |                         | pediatrice                                    |
|____|_________________________|_______________________________________________|
| 41.| SR EN 13014:2003        | Racorduri pentru tuburile de prelevare a      |
|    |                         | gazelor echipamentului de anestezie si        |
|    |                         | respiratie                                    |
|____|_________________________|_______________________________________________|
| 42.| SR EN 13220:2003        | Dispozitive cu debitmetre pentru prizele de   |
|    |                         | perete ale retelelor de distributie a gazelor |
|    |                         | medicale                                      |
|____|_________________________|_______________________________________________|
| 43.| SR EN 13221:2002        | Conexiuni flexibile de inalta presiune pentru |
|    |                         | utilizare cu gaze medicale                    |
|____|_________________________|_______________________________________________|
| 44.| SR EN 13328-1:2003      | Filtre pentru sisteme respiratorii pentru     |
|    |                         | anestezie si ingrijire medicala respiratorie. |
|    |                         | Partea 1: Metoda de incercare cu solutie      |
|    |                         | salina pentru evaluarea performantelor        |
|    |                         | filtrarii                                     |
|____|_________________________|_______________________________________________|
| 45.| SR EN 13328-2:2003      | Filtre pentru sisteme respiratorii utilizate  |
|    |                         | in anestezie si respiratie.                   |
|    |                         | Partea 2: Aspecte altele decat filtrarea      |
|____|_________________________|_______________________________________________|
| 46.| SR EN 13503-8:2002      | Implanturi oftalmice. Lentile intraoculare.   |
|    |                         | Partea 8: Cerinte fundamentale                |
|____|_________________________|_______________________________________________|
| 47.| SR EN 13544-1:2003      | Echipament de terapie respiratorie.           |
|    |                         | Partea 1: Sisteme de dispozitive pentru       |
|    |                         | aerosoli si componentele lor                  |
|____|_________________________|_______________________________________________|
| 48.| SR EN 13544-2:2003      | Echipament pentru terapie respiratorie.       |
|    |                         | Partea 2: Tuburi si conectoare                |
|____|_________________________|_______________________________________________|
| 49.| SR EN 13544-3:2002      | Echipament de terapie respiratorie. Partea 3: |
|    |                         | Dispozitive de antrenare a aerului            |
|____|_________________________|_______________________________________________|
| 50.| SR EN 13718-1:2003      | Ambulante aeriene, maritime si de teren       |
|    |                         | dificil. Partea 1: Cerinte referitoare la     |
|    |                         | interfata dispozitivelor medicale pentru      |
|    |                         | continuitatea ingrijirii pacientilor          |
|____|_________________________|_______________________________________________|
| 51.| SR EN 13718-2:2003      | Ambulante aeriene, maritime si de teren       |
|    |                         | dificil. Partea 2: Cerinte tehnice si         |
|    |                         | operationale pentru continuitatea ingrijirii  |
|    |                         | pacientului                                   |
|____|_________________________|_______________________________________________|
| 52.| SR EN 13726-1:2003      | Metode de incercare pentru pansamente primare |
|    |                         | in contact cu rana. Partea 1: Aspecte ale     |
|    |                         | absorbtiei                                    |
|____|_________________________|_______________________________________________|
| 53.| SR EN 13726-2:2003      | Metode de incercare pentru pansamente primare |
|    |                         | in contact cu rana. Partea 2: Rata            |
|    |                         | transmisiei vaporilor de apa prin pansamente  |
|    |                         | cu film permeabil                             |
|____|_________________________|_______________________________________________|
| 54.| SR EN 13726-3:2003      | Dispozitive medicale neactive. Metode de      |
|    |                         | incercare pentru pansamentele primare in      |
|    |                         | contact cu plaga. Partea 3: Rezistenta la     |
|    |                         | penetrarea apei                               |
|____|_________________________|_______________________________________________|
| 55.| SR EN 13726-4:2003      | Dispozitive medicale neactive. Metode de      |
|    |                         | incercare pentru pansamentele primare in      |
|    |                         | contact cu plaga. Partea 4: Conformabilitate  |
|____|_________________________|_______________________________________________|
| 56.| SR EN 13867:2003        | Concentrate pentru hemodializa si terapii     |
|    |                         | asociate                                      |
|____|_________________________|_______________________________________________|
| 57.| SR EN 14079:2003        | Dispozitive medicale neactive. Cerinte de     |
|    |                         | performanta si metode de incercare pentru     |
|    |                         | tifon de bumbac absorbant si tifon absorbant  |
|    |                         | de bumbac si vascoza                          |
|____|_________________________|_______________________________________________|
| 58.| SR EN 1422:2003         | Sterilizatoare de uz medical. Sterilizatoare  |
|    |                         | cu oxid de etilena. Cerinte si metode de      |
|    |                         | verificare                                    |
|____|_________________________|_______________________________________________|
| 59.| SR EN 1618:2003         | Catetere altele decat catetere intravasculare.|
|    |                         | Metode de incercare pentru proprietatile      |
|    |                         | comune                                        |
|____|_________________________|_______________________________________________|
| 60.| SR EN 1639:1999         | Stomatologie. Dispozitive medicale pentru     |
|    |                         | stomatologie. Instrumente                     |
|____|_________________________|_______________________________________________|
| 61.| SR EN 1640:1999         | Stomatologie. Dispozitive medicale pentru     |
|    |                         | stomatologie. Echipament                      |
|____|_________________________|_______________________________________________|
| 62.| SR EN 1641:1999         | Stomatologie. Dispozitive medicale pentru     |
|    |                         | stomatologie. Materiale                       |
|____|_________________________|_______________________________________________|
| 63.| SR EN 1642:1999         | Stomatologie. Dispozitive medicale pentru     |
|    |                         | stomatologie. Implanturi dentare              |
|____|_________________________|_______________________________________________|
| 64.| SR EN 1707:2003         | Asamblari conice 6% (Luer) pentru seringi,    |
|    |                         | ace si alte echipamente medicale de precizie. |
|    |                         | Asamblari de blocare                          |
|____|_________________________|_______________________________________________|
| 65.| SR EN 1782:2003         | Tuburi traheale si racorduri                  |
|____|_________________________|_______________________________________________|
| 66.| SR EN 1789:2002/A1:2003 | Vehicule medicale si echipamentele lor.       |
|    |                         | Ambulante                                     |
|____|_________________________|_______________________________________________|
| 67.| SR EN 1819:2003         | Laringoscoape pentru intubatie traheala.      |
|    |                         | Cerinte particulare                           |
|____|_________________________|_______________________________________________|
| 68.| SR EN 1820:2003         | Balon rezervor pentru anestezie               |
|____|_________________________|_______________________________________________|
| 69.| SR EN 1865:2003         | Specificatii pentru brancarde si alte         |
|    |                         | echipamente pentru transportul pacientilor in |
|    |                         | ambulante                                     |
|____|_________________________|_______________________________________________|
| 70.| SR EN 1970:2002         | Paturi reglabile pentru persoane invalide.    |
|    |                         | Cerinte si metode de incercare                |
|____|_________________________|_______________________________________________|
| 71.| SR EN 1985:2001         | Mijloace ajutatoare pentru mers. Cerinte      |
|    |                         | generale si metode de incercare               |
|____|_________________________|_______________________________________________|
| 72.| SR EN 20594-1:2003      | Asamblari conice 6% (Luer) pentru seringi si  |
|    |                         | ace si pentru alte aparate de uz medical.     |
|    |                         | Partea 1: Conditii generale                   |
|____|_________________________|_______________________________________________|
| 73.| SR EN 20594-1:2003/     | Asamblari conice 6% (Luer) pentru seringi si  |
|    | A1:2003                 | ace si pentru aparate de uz medical.          |
|    |                         | Partea 1: Conditii generale                   |
|____|_________________________|_______________________________________________|
| 74.| SR EN 27740:2003        | Instrumente chirurgicale, bisturie cu lame    |
|    |                         | detasabile, dimensiuni pentru fitinguri       |
|____|_________________________|_______________________________________________|
| 75.| SR EN 27740:2003/A1:2003| Instrumente chirurgicale, bisturie cu lame    |
|    |                         | detasabile, dimensiuni pentru fitinguri       |
|____|_________________________|_______________________________________________|
| 76.| SR EN 285:2003          | Sterilizare. Sterilizare cu abur.             |
|    |                         | Sterilizatoare mari                           |
|____|_________________________|_______________________________________________|
| 77.| SR EN 30993-3:1996      | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 3: Teste pentru genotoxicitate,        |
|    |                         | carcinogenitale si efectul toxicitatii        |
|    |                         | asupra functiei de reproducere                |
|____|_________________________|_______________________________________________|
| 78.| SR EN 30993-6:1998      | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 6: Teste pentru efecte locale dupa     |
|    |                         | implantare                                    |
|____|_________________________|_______________________________________________|
| 79.| SR EN 375:2003          | Informatii furnizate de producator privind    |
|    |                         | reactivii de diagnostic in vitro pentru uz    |
|    |                         | profesional                                   |
|____|_________________________|_______________________________________________|
| 80.| SR EN 376:2003          | Informatii furnizate de producator privind    |
|    |                         | reactivii de diagnostic in vitro pentru       |
|    |                         | autotestare                                   |
|____|_________________________|_______________________________________________|
| 81.| SR EN 455-1:2003        | Manusi medicale de unica utilizare. Partea 1: |
|    |                         | Detectarea gaurilor. Prescriptii si incercari |
|____|_________________________|_______________________________________________|
| 82.| SR EN 455-2:2003        | Manusi medicale de unica utilizare. Partea 2: |
|    |                         | Cerinte si metode de incercare a              |
|    |                         | proprietatilor fizice                         |
|____|_________________________|_______________________________________________|
| 83.| SR EN 455-3:2003        | Manusi medicale de unica utilizare. Partea 3: |
|    |                         | Cerinte si incercari pentru evaluarea         |
|    |                         | biologica                                     |
|____|_________________________|_______________________________________________|
| 84.| SR EN 46003:2001        | Sistemele calitatii. Dispozitive medicale.    |
|    |                         | Cerinte particulare pentru aplicarea          |
|    |                         | EN ISO 9003                                   |
|____|_________________________|_______________________________________________|
| 85.| SR EN 475:2003          | Dispozitive medicale. Semnale de alarma       |
|    |                         | electrice                                     |
|____|_________________________|_______________________________________________|
| 86.| SR EN 50103:2001        | Ghid pentru aplicarea EN 29001, EN 46001 si   |
|    |                         | EN 29002, EN 46002 pentru industria           |
|    |                         | dispozitivelor medicale active (inclusiv      |
|    |                         | implantabile active)                          |
|____|_________________________|_______________________________________________|
| 87.| SR EN 540:1996          | Investigatia clinica a dispozitivelor medicale|
|    |                         | pe subiecti umani                             |
|____|_________________________|_______________________________________________|
| 88.| SR EN 550:1997          | Sterilizarea dispozitivelor medicale. Validare|
|    |                         | si control de rutina pentru sterilizarea cu   |
|    |                         | oxid de etilena                               |
|____|_________________________|_______________________________________________|
| 89.| SR EN 552:2001          | Sterilizarea dispozitivelor medicale. Validare|
|    |                         | si control de rutina pentru sterilizare prin  |
|    |                         | iradiere                                      |
|____|_________________________|_______________________________________________|
| 90.| SR EN 552:2001/A1:2003  | Sterilizarea dispozitivelor medicale. Validare|
|    |                         | si control de rutina pentru sterilizare prin  |
|    |                         | iradiere                                      |
|____|_________________________|_______________________________________________|
| 91.| SR EN 552:2001/A2:2003  | Sterilizarea dispozitivelor medicale. Validare|
|    |                         | si control de rutina pentru sterilizarea prin |
|    |                         | iradiere                                      |
|____|_________________________|_______________________________________________|
| 92.| SR EN 554:2003          | Sterilizarea dispozitivelor medicale. Validare|
|    |                         | si control de rutina pentru sterilizarea cu   |
|    |                         | caldura umeda                                 |
|____|_________________________|_______________________________________________|
| 93.| SR EN 556:2001          | Sterilizarea dispozitivelor medicale. Cerinte |
|    |                         | pentru dispozitive medicale etichetate        |
|    |                         | "steril"                                      |
|____|_________________________|_______________________________________________|
| 94.| SR EN 556-1:2003        | Sterilizarea dispozitivelor medicale. Cerinte |
|    |                         | pentru dispozitivele medicale etichetate      |
|    |                         | "steril". Partea 1: Cerinte pentru            |
|    |                         | dispozitivele medicale sterilizate in faza    |
|    |                         | finala                                        |
|____|_________________________|_______________________________________________|
| 95.| SR EN 591:2003          | Instructiuni pentru utilizarea instrumentelor |
|    |                         | de diagnostic in vitro de uz profesional      |
|____|_________________________|_______________________________________________|
| 96.| SR EN 592:2003          | Instructiuni de utilizare a instrumentelor de |
|    |                         | diagnosticare in vitro pentru utilizare ca    |
|    |                         | autotest                                      |
|____|_________________________|_______________________________________________|
| 97.| SR EN 600:1999          | Prezervative masculine de latex de cauciuc    |
|    |                         | natural                                       |
|____|_________________________|_______________________________________________|
| 98.| SR EN 60118-13:2003     | Aparate de corectie auditiva. Partea 13:      |
|    |                         | Compatibilitate electromagnetica (CEM)        |
|____|_________________________|_______________________________________________|
| 99.| SR EN 60601-1+A1+A2+    | Aparate electromedicale. Partea 1: Cerinte    |
|    | A13:2001                | generale de securitate                        |
|____|_________________________|_______________________________________________|
|100.| SR EN 60601-1-1:2003    | Aparate electromedicale. Partea 1-1: Cerinte  |
|    |                         | generale de securitate. Standard colateral:   |
|    |                         | Cerinte de securitate pentru sisteme          |
|    |                         | electromedicale                               |
|____|_________________________|_______________________________________________|
|101.| SR EN 60601-1-2:2003    | Aparatura electromedicala. Partea 1-2: Cerinte|
|    |                         | generale de securitate. Standard colateral:   |
|    |                         | Compatibilitate electromagnetica. Cerinte si  |
|    |                         | incercari                                     |
|____|_________________________|_______________________________________________|
|102.| SR EN 60601-1-3:2003    | Aparate electromedicale. Partea 1-3: Cerinte  |
|    |                         | generale de securitate 3. Standard colateral: |
|    |                         | Cerinte generale pentru protectia impotriva   |
|    |                         | radiatiei la aparatele de diagnostic cu       |
|    |                         | radiatii X                                    |
|____|_________________________|_______________________________________________|
|103.| SR EN 60601-1-4:2002    | Aparate electromedicale. Partea 1: Cerinte    |
|    |                         | generale de securitate. 4 Standard colateral: |
|    |                         | Sisteme electromedicale programabile          |
|____|_________________________|_______________________________________________|
|104.| SR EN 60601-1-4:2002/   | Aparate electromedicale. Partea 1-4: Cerinte  |
|    | A1:2002                 | generale de securitate. Standard colateral:   |
|    |                         | Sisteme electromedicale programabile          |
|____|_________________________|_______________________________________________|
|105.| SR EN 60601-2-1:2003    | Aparate electromedicale. Partea 2-1: Cerinte  |
|    |                         | particulare de securitate pentru acceleratoare|
|    |                         | de electroni in domeniul de la 1 MeV pana la  |
|    |                         | 50 MeV                                        |
|____|_________________________|_______________________________________________|
|106.| SR EN 60601-2-1:2003/   | Aparate electromedicale. Partea 2-1: Cerinte  |
|    | A1:2003                 | particulare de securitate pentru acceleratoare|
|    |                         | de electroni in domeniul de la 1 MeV pana la  |
|    |                         | 50 MeV                                        |
|____|_________________________|_______________________________________________|
|107.| SR EN 60601-2-10:2003   | Aparate electromedicale. Partea 2-10: Cerinte |
|    |                         | particulare de securitate pentru stimulatoare |
|    |                         | de nervi si muschi                            |
|____|_________________________|_______________________________________________|
|108.| SR EN 60601-2-10:2003/  | Aparate electromedicale. Partea 2-10: Cerinte |
|    | A1:2003                 | particulare de securitate pentru stimulatoare |
|    |                         | de nervi si muschi                            |
|____|_________________________|_______________________________________________|
|109.| SR EN 60601-2-11:2003   | Aparate electromedicale. Partea 2-11: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | terapie cu radiatii gama                      |
|____|_________________________|_______________________________________________|
|110.| SR EN 60601-2-16:2003   | Aparate electromedicale. Partea 2-16: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | hemodializa, hemodiafiltrare si hemofiltrare  |
|____|_________________________|_______________________________________________|
|111.| SR EN 60601-2-17:2003   | Aparate electromedicale. Partea 2-17: Cerinte |
|    |                         | particulare de securitate pentru echipamente  |
|    |                         | actionate de la distanta cu comanda automata, |
|    |                         | utilizate in brahiterapie cu radiatii gama    |
|____|_________________________|_______________________________________________|
|112.| SR EN 60601-2-17:2003/  | Aparate electromedicale. Partea 2-17: Cerinte |
|    | A1:2003                 | particulare de securitate pentru echipamente  |
|    |                         | actionate de la distanta cu comanda automata, |
|    |                         | utilizate in brahiterapie cu radiatii gama    |
|____|_________________________|_______________________________________________|
|113.| SR EN 60601-2-18:2003   | Aparate electromedicale. Partea 2-18: Cerinte |
|    |                         | particulare de securitate ale echipamentelor  |
|    |                         | pentru endoscopie                             |
|____|_________________________|_______________________________________________|
|114.| SR EN 60601-2-19:2003   | Aparate electromedicale. Partea 2-19: Cerinte |
|    |                         | particulare de securitate ale incubatoarelor  |
|    |                         | pentru nou-nascuti                            |
|____|_________________________|_______________________________________________|
|115.| SR EN 60601-2-19:2003/  | Aparate electromedicale. Partea 2-19: Cerinte |
|    | A1:2003                 | particulare de securitate ale incubatoarelor  |
|    |                         | pentru nou-nascuti                            |
|____|_________________________|_______________________________________________|
|116.| SR EN 60601-2-2:2001    | Aparate electromedicale. Partea 2-2: Cerinte  |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | electrochirurgie cu curenti de inalta         |
|    |                         | frecventa                                     |
|____|_________________________|_______________________________________________|
|117.| SR EN 60601-2-20:2003   | Aparate electromedicale. Partea 2-20: Cerinte |
|    |                         | particulare de securitate pentru incubatoare  |
|    |                         | de transport                                  |
|____|_________________________|_______________________________________________|
|118.| SR EN 60601-2-21:2003   | Aparate electromedicale. Partea 2-21: Cerinte |
|    |                         | particulare de securitate ale sistemelor de   |
|    |                         | incalzire cu suprafata radianta pentru nou-   |
|    |                         | nascuti                                       |
|____|_________________________|_______________________________________________|
|119.| SR EN 60601-2-21:2003/  | Aparate electromedicale. Partea 2-21: Cerinte |
|    | A1:2003                 | particulare de securitate ale sistemelor de   |
|    |                         | incalzire cu suprafata radianta pentru nou-   |
|    |                         | nascuti                                       |
|____|_________________________|_______________________________________________|
|120.| SR EN 60601-2-22:2003   | Aparate electromedicale. Partea 2: Cerinte    |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | diagnostic si de tratament cu laser           |
|____|_________________________|_______________________________________________|
|121.| SR EN 60601-2-23:2003   | Aparate electromedicale. Partea 2-23: Cerinte |
|    |                         | particulare de securitate si performante      |
|    |                         | esentiale ale aparatelor de monitorizare a    |
|    |                         | presiunii partiale transcutanate              |
|____|_________________________|_______________________________________________|
|122.| SR EN 60601-2-24:2003   | Aparate electromedicale. Partea 2-24: Cerinte |
|    |                         | particulare de securitate ale pompelor de     |
|    |                         | perfuzie si dispozitivelor de reglare a       |
|    |                         | perfuziei                                     |
|____|_________________________|_______________________________________________|
|123.| SR EN 60601-2-25+A1:2001| Aparate electromedicale. Partea 2-25: Cerinte |
|    |                         | particulare de securitate pentru              |
|    |                         | electrocardiografe                            |
|____|_________________________|_______________________________________________|
|124.| SR EN 60601-2-26:2003   | Aparate electromedicale. Partea 2-26: Cerinte |
|    |                         | particulare de securitate pentru              |
|    |                         | electroencefalografe                          |
|____|_________________________|_______________________________________________|
|125.| SR EN 60601-2-27:2003   | Aparate electromedicale. Partea 2: Cerinte    |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | monitorizare electrocardiografica             |
|____|_________________________|_______________________________________________|
|126.| SR EN 60601-2-28:2003   | Aparate electromedicale. Partea 2: Cerinte    |
|    |                         | particulare de securitate pentru ansambluri cu|
|    |                         | surse de radiatii X si cu tuburi de radiatii X|
|    |                         | pentru diagnostic medical                     |
|____|_________________________|_______________________________________________|
|127.| SR EN 60601-2-29:2003   | Aparate electromedicale. Partea 2-29: Cerinte |
|    |                         | particulare de securitate pentru simulatoare  |
|    |                         | de radioterapie                               |
|____|_________________________|_______________________________________________|
|128.| SR EN 60601-2-3:2003    | Aparate electromedicale. Partea 2-3: Cerinte  |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | terapie cu unde scurte                        |
|____|_________________________|_______________________________________________|
|129.| SR EN 60601-2-3:2003/   | Aparate electromedicale. Partea 2-3: Cerinte  |
|    | A1:2003                 | particulare de securitate pentru aparate de   |
|    |                         | terapie cu unde scurte                        |
|____|_________________________|_______________________________________________|
|130.| SR EN 60601-2-30:2003   | Aparate electromedicale. Partea 2-30: Cerinte |
|    |                         | particulare de securitate si performante      |
|    |                         | esentiale ale aparatelor de monitorizare a    |
|    |                         | presiunii sanguine masurate neinvaziv, automat|
|    |                         | si periodic                                   |
|____|_________________________|_______________________________________________|
|131.| SR EN 60601-2-31:2003   | Aparate electromedicale. Partea 2-31: Cerinte |
|    |                         | particulare de securitate pentru stimulatoare |
|    |                         | cardiace externe cu sursa de alimentare       |
|    |                         | interna                                       |
|____|_________________________|_______________________________________________|
|132.| SR EN 60601-2-31:2003/  | Aparate electromedicale. Partea 2-31: Cerinte |
|    | A1:2003                 | particulare de securitate pentru stimulatoare |
|    |                         | cardiace externe cu sursa de alimentare       |
|    |                         | interna                                       |
|____|_________________________|_______________________________________________|
|133.| SR EN 60601-2-32:2003   | Aparate electromedicale. Partea 2-32: Cerinte |
|    |                         | particulare de securitate pentru echipamente  |
|    |                         | asociate echipamentelor cu radiatii X         |
|____|_________________________|_______________________________________________|
|134.| SR EN 60601-2-33:2003   | Aparate electromedicale. Partea 2-33: Cerinte |
|    |                         | particulare de securitate pentru aparate cu   |
|    |                         | rezonanta magnetica utilizate pentru          |
|    |                         | diagnostic medical                            |
|____|_________________________|_______________________________________________|
|135.| SR EN 60601-2-33:2003/  | Aparate electromedicale. Partea 2-33: Cerinte |
|    | A11:2003                | particulare de securitate pentru aparate cu   |
|    |                         | rezonanta magnetica utilizate pentru          |
|    |                         | diagnostic medical                            |
|____|_________________________|_______________________________________________|
|136.| SR EN 60601-2-34:2003   | Aparate electromedicale. Partea 2-34: Cerinte |
|    |                         | particulare de securitate, incluzand          |
|    |                         | performantele de baza, pentru aparate de      |
|    |                         | monitorizare invaziva a presiunii sanguine    |
|____|_________________________|_______________________________________________|
|137.| SR EN 60601-2-35:2003   | Aparate electromedicale. Partea 2: Cerinte    |
|    |                         | particulare de securitate pentru paturi, perne|
|    |                         | si saltele destinate incalzirii pacientilor in|
|    |                         | utilizari medicale                            |
|____|_________________________|_______________________________________________|
|138.| SR EN 60601-2-36:2003   | Aparate electromedicale. Partea 2-36: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | litotritie extracorporala                     |
|____|_________________________|_______________________________________________|
|139.| SR EN 60601-2-37:2003   | Aparate electromedicale. Partea 2-37: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | diagnostic medical si aparate de monitorizare |
|    |                         | cu ultrasunete                                |
|____|_________________________|_______________________________________________|
|140.| SR EN 60601-2-38:2003   | Aparate electromedicale. Partea 2-38: Cerinte |
|    |                         | particulare de securitate pentru paturile de  |
|    |                         | spital actionate electric                     |
|____|_________________________|_______________________________________________|
|141.| SR EN 60601-2-38:2003/  | Aparate electromedicale. Partea 2-38: Cerinte |
|    | A1:2003                 | particulare de securitate pentru paturile de  |
|    |                         | spital actionate electric                     |
|____|_________________________|_______________________________________________|
|142.| SR EN 60601-2-39:2002   | Aparate electromedicale. Partea 2-39: Cerinte |
|    |                         | particulare de securitate pentru aparatele de |
|    |                         | dializa peritoneala                           |
|____|_________________________|_______________________________________________|
|143.| SR EN 60601-2-4:2003    | Aparate electromedicale. Partea 2-4: Cerinte  |
|    |                         | particulare de securitate pentru              |
|    |                         | defibrilatoare cardiace                       |
|____|_________________________|_______________________________________________|
|144.| SR EN 60601-2-40:2003   | Aparate electromedicale. Partea 2-40: Cerinte |
|    |                         | particulare de securitate pentru              |
|    |                         | electromiografe si aparate pe baza de         |
|    |                         | potentiale evocate                            |
|____|_________________________|_______________________________________________|
|145.| SR EN 60601-2-44:2003   | Aparate electromedicale. Partea 2-44: Cerinte |
|    |                         | particulare de securitate pentru aparate cu   |
|    |                         | radiatii X pentru tomografie computerizata    |
|____|_________________________|_______________________________________________|
|146.| SR EN 60601-2-44:2003/  | Aparate electromedicale. Partea 2-44: Cerinte |
|    | A1:2003                 | particulare de securitate pentru aparate cu   |
|    |                         | radiatii X pentru tomografie computerizata    |
|____|_________________________|_______________________________________________|
|147.| SR EN 60601-2-45:2003   | Aparate electromedicale. Partea 2-45: Cerinte |
|    |                         | particulare de securitate ale aparatelor      |
|    |                         | radiologice pentru mamografie si ale          |
|    |                         | dispozitivelor stereotactice pentru mamografie|
|____|_________________________|_______________________________________________|
|148.| SR EN 60601-2-46:2002   | Aparate electromedicale. Partea 2-46: Cerinte |
|    |                         | particulare de securitate pentru mesele de    |
|    |                         | operatie                                      |
|____|_________________________|_______________________________________________|
|149.| SR EN 60601-2-47:2003   | Aparate electromedicale. Partea 2-47: Cerinte |
|    |                         | particulare de securitate, inclusiv           |
|    |                         | performante esentiale, pentru sisteme de      |
|    |                         | electrocardiografie ambulatorie               |
|____|_________________________|_______________________________________________|
|150.| SR EN 60601-2-49:2003   | Aparate electromedicale. Partea 2-49: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | monitorizare multifunctionala a pacientilor   |
|____|_________________________|_______________________________________________|
|151.| SR EN 60601-2-50:2003   | Aparate electromedicale. Partea 2-50: Cerinte |
|    |                         | particulare de securitate pentru aparate de   |
|    |                         | fototerapie infantila                         |
|____|_________________________|_______________________________________________|
|152.| SR EN 60601-2-7:2003    | Aparate electromedicale. Partea 2-7: Cerinte  |
|    |                         | particulare de securitate pentru generatoarele|
|    |                         | de inalta tensiune ale generatoarelor de      |
|    |                         | radiatii X pentru diagnostic                  |
|____|_________________________|_______________________________________________|
|153.| SR EN 60601-2-8:2002    | Aparate electromedicale. Partea 2-8: Cerinte  |
|    |                         | particulare de securitate pentru echipamentele|
|    |                         | de terapie cu radiatii X care functioneaza in |
|    |                         | domeniul de la 10 kV pana la 1 MV             |
|____|_________________________|_______________________________________________|
|154.| SR EN 60601-2-8:2002/   | Aparate electromedicale. Partea 2-8: Cerinte  |
|    | A1:2003                 | particulare de securitate pentru aparate de   |
|    |                         | terapie cu radiatii X care functioneaza in    |
|    |                         | domeniul de la 10 kV pana la 1 MV             |
|____|_________________________|_______________________________________________|
|155.| SR EN 60601-2-9:2003    | Aparate electromedicale. Partea 2-9: Cerinte  |
|    |                         | particulare de securitate pentru dozimetre in |
|    |                         | contact cu pacientul, cu detectoare de        |
|    |                         | radiatii conectate electric, utilizate in     |
|    |                         | radioterapie                                  |
|____|_________________________|_______________________________________________|
|156.| SR EN 60627:2003        | Aparate de diagnostic prin imagistica cu      |
|    |                         | radiatii X. Caracteristici ale grilelor       |
|    |                         | antidifuzante pentru uz general si pentru     |
|    |                         | mamografie                                    |
|____|_________________________|_______________________________________________|
|157.| SR EN 60645-1:2003      | Electroacustica. Echipamente audiologice.     |
|    |                         | Partea 1: Audiometre tonale                   |
|____|_________________________|_______________________________________________|
|158.| SR EN 60645-2:2003      | Audiometre. Partea 2: Aparat pentru           |
|    |                         | audiometrie vocala                            |
|____|_________________________|_______________________________________________|
|159.| SR EN 60645-3:2003      | Audiometre. Partea 3: Semnale de scurta durata|
|    |                         | pentru incercari audiometrice si              |
|    |                         | oto-neurologice                               |
|____|_________________________|_______________________________________________|
|160.| SR EN 60645-4:2003      | Audiometre. Partea 4: Echipamente pentru      |
|    |                         | audiometria extinsa la domeniul frecventelor  |
|    |                         | ridicate                                      |
|____|_________________________|_______________________________________________|
|161.| SR EN 61217:2001        | Echipamente de radioterapie. Coordonate,      |
|    |                         | miscari si scale                              |
|____|_________________________|_______________________________________________|
|162.| SR EN 61223-3-4:2003    | Incercari de evaluare si de rutina in         |
|    |                         | serviciile de imagistica medicala. Partea 3-4:|
|    |                         | Incercari de receptie. Performanta imagistica |
|    |                         | in aparatura dentara cu radiatii X            |
|____|_________________________|_______________________________________________|
|163.| SR EN 62083:2003        | Aparate electromedicale. Cerinte de securitate|
|    |                         | pentru sistemele de planificare a             |
|    |                         | tratamentului in radioterapie                 |
|____|_________________________|_______________________________________________|
|164.| SR EN 724:2000          | Ghid pentru aplicarea EN 29001, EN 46001 si   |
|    |                         | EN 29002, EN 46002 pentru dispozitive medicale|
|    |                         | neactive                                      |
|____|_________________________|_______________________________________________|
|165.| SR EN 737-1:2003        | Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 1: Prize de perete pentru gazele       |
|    |                         | medicale comprimate si pentru vid (aspiratie) |
|____|_________________________|_______________________________________________|
|166.| SR EN 737-2:2003        | Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 2: Sisteme finale de evacuare a gazelor|
|    |                         | de anestezie. Reguli de baza                  |
|____|_________________________|_______________________________________________|
|167.| SR EN 737-2:2003/A1:2003| Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 2: Sisteme finale de evacuare a gazelor|
|    |                         | de anestezie. Reguli de baza                  |
|____|_________________________|_______________________________________________|
|168.| SR EN 737-3:2003        | Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 3: Sisteme de distributie pentru gaze  |
|    |                         | medicale comprimate si vacuum (vid)           |
|____|_________________________|_______________________________________________|
|169.| SR EN 737-3:2003/A1:2003| Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 3: Sisteme de distributie pentru gaze  |
|    |                         | medicale comprimate si vacuum (vid)           |
|____|_________________________|_______________________________________________|
|170.| SR EN 737-4:2003        | Sisteme de distributie a gazelor medicale.    |
|    |                         | Partea 4: Prize de perete pentru sisteme de   |
|    |                         | evacuare a gazelor anestezice                 |
|____|_________________________|_______________________________________________|
|171.| SR EN 738-1:2003        | Regulatoare de presiune pentru gaze medicale. |
|    |                         | Partea 1: Regulatoare de presiune si          |
|    |                         | regulatoare de presiune cu debitmetre         |
|____|_________________________|_______________________________________________|
|172.| SR EN 738-1:2003/A1:2003| Regulatoare de presiune utilizate pentru gaze |
|    |                         | de uz medical. Partea 1: Regulatoare de       |
|    |                         | presiune si regulatoare cu debitmetre         |
|____|_________________________|_______________________________________________|
|173.| SR EN 738-2:2003        | Regulatoare de presiune pentru gaze medicale. |
|    |                         | Partea 2: Regulatoare de presiune pentru rampe|
|    |                         | si canalizare                                 |
|____|_________________________|_______________________________________________|
|174.| SR EN 738-3:2003        | Regulatoare de presiune pentru gaze medicale. |
|    |                         | Partea 3: Regulatoare de presiune integrate in|
|    |                         | robinetele buteliilor de gaz                  |
|____|_________________________|_______________________________________________|
|175.| SR EN 738-3:2003/A1:2003| Regulatoare de presiune utilizate pentru gaze |
|    |                         | de uz medical. Partea 3: Regulatoare de       |
|    |                         | presiune integrate cu valve cilindrice        |
|____|_________________________|_______________________________________________|
|176.| SR EN 738-4:2003        | Regulatoare de presiune pentru utilizarea cu  |
|    |                         | gaze medicale. Partea 4: Regulatoare de joasa |
|    |                         | presiune destinate echipamentelor medicale    |
|____|_________________________|_______________________________________________|
|177.| SR EN 738-4:2003/A1:2003| Regulatoare de presiune utilizate pentru gaze |
|    |                         | de uz medical. Partea 4: Regulatoare de joasa |
|    |                         | presiune incluse intr-un echipament medical.  |
|____|_________________________|_______________________________________________|
|178.| SR EN 739:2003          | Racorduri flexibile la presiune scazuta pentru|
|    |                         | utilizare cu gaze medicale                    |
|____|_________________________|_______________________________________________|
|179.| SR EN 739:2003/A1:2003  | Racorduri flexibile de joasa presiune         |
|    |                         | utilizate pentru gaze de uz medical           |
|____|_________________________|_______________________________________________|
|180.| SR EN 740:2003          | Sisteme de anestezie si modulele lor. Reguli  |
|    |                         | particulare                                   |
|____|_________________________|_______________________________________________|
|181.| SR EN 793:2003          | Cerinte particulare pentru securitatea        |
|    |                         | surselor de alimentare pentru uz medical      |
|____|_________________________|_______________________________________________|
|182.| SR EN 794-1:2003        | Ventilatoare pulmonare. Partea 1: Cerinte     |
|    |                         | particulare pentru ventilatoarele pentru      |
|    |                         | ingrijiri critice                             |
|____|_________________________|_______________________________________________|
|183.| SR EN 794-1/A1:2002     | Ventilatoare pulmonare. Partea 1: Cerinte     |
|    |                         | particulare ale ventilatoarelor pentru        |
|    |                         | ingrijire in situatii critice                 |
|____|_________________________|_______________________________________________|
|184.| SR EN 794-2:2003        | Ventilatoare pulmonare. Partea 2: Cerinte     |
|    |                         | particulare pentru utilizare la domiciliu     |
|____|_________________________|_______________________________________________|
|185.| SR EN 794-3:2003        | Ventilatoare pulmonare. Partea 3: Cerinte     |
|    |                         | particulare pentru ventilatoarele pentru      |
|    |                         | urgente si transport                          |
|____|_________________________|_______________________________________________|
|186.| SR EN 864:2003          | Aparate electromedicale. Capnometre pentru    |
|    |                         | utilizare umana. Cerinte particulare          |
|____|_________________________|_______________________________________________|
|187.| SR EN 865:2003          | Pulsoximetre. Cerinte particulare             |
|____|_________________________|_______________________________________________|
|188.| SR EN 867-2:2003        | Sisteme nebiologice pentru utilizare in       |
|    |                         | sterilizatoare. Partea 2: Indicatori de proces|
|    |                         | (Clasa A)                                     |
|____|_________________________|_______________________________________________|
|189.| SR EN 867-3:2003        | Sisteme nebiologice destinate utilizarii in   |
|    |                         | sterilizatoare. Partea 3: Specificatie pentru |
|    |                         | indicatorii de Clasa B utilizati in testul    |
|    |                         | Bowie si Dick                                 |
|____|_________________________|_______________________________________________|
|190.| SR EN 868-1:2003        | Materiale si sisteme de ambalare pentru       |
|    |                         | dispozitivele medicale care urmeaza a fi      |
|    |                         | sterilizate                                   |
|____|_________________________|_______________________________________________|
|191.| SR EN 980:2003          | Simboluri grafice utilizate pentru etichetarea|
|    |                         | dispozitivelor medicale                       |
|____|_________________________|_______________________________________________|
|192.| SR EN 980/A1:2003       | Simboluri grafice utilizate pentru etichetarea|
|    |                         | dispozitivelor medicale                       |
|____|_________________________|_______________________________________________|
|193.| SR EN ISO 10079-1:2003  | Aspiratoare medicale. Partea 1: Aspiratoare   |
|    |                         | medicale actionate electric. Cerinte de       |
|    |                         | securitate                                    |
|____|_________________________|_______________________________________________|
|194.| SR EN ISO 10079-2:2003  | Aspiratoare medicale. Partea 2: Aspiratoare   |
|    |                         | medicale actionate manual                     |
|____|_________________________|_______________________________________________|
|195.| SR EN ISO 10079-3:2003  | Aspiratoare medicale. Partea 3: Aspiratoare   |
|    |                         | medicale actionate printr-o sursa de vacuum   |
|    |                         | sau de presiune                               |
|____|_________________________|_______________________________________________|
|196.| SR EN ISO 10535:2000    | Elevatoare pentru transferul persoanelor cu   |
|    |                         | deficiente. Cerinte si metode de incercare    |
|____|_________________________|_______________________________________________|
|197.| SR EN ISO 10555-1:2003  | Catetere intravasculare sterile, de unica     |
|    |                         | utilizare. Partea 1: Cerinte generale         |
|____|_________________________|_______________________________________________|
|198.| SR EN ISO 10555-1:2003/ | Catetere intravasculare sterile, de unica     |
|    | A1:2003                 | utilizare. Partea 1: Cerinte generale         |
|____|_________________________|_______________________________________________|
|199.| SR EN ISO 10651-4:2003  | Ventilatoare pulmonare. Partea 4: Cerinte     |
|    |                         | particulare pentru resuscitori actionati      |
|    |                         | manual                                        |
|____|_________________________|_______________________________________________|
|200.| SR EN ISO 10993-1:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 1: Evaluare si testare                 |
|____|_________________________|_______________________________________________|
|201.| SR EN ISO 10993-10:2002 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 10: Teste de iritare si de             |
|    |                         | hipersensibilitate cu efect retard            |
|____|_________________________|_______________________________________________|
|202.| SR EN ISO 10993-11:1998 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 11: Teste pentru toxicitate sistemica  |
|____|_________________________|_______________________________________________|
|203.| SR EN ISO 10993-12:2003 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 12: Prepararea esantioanelor si a      |
|    |                         | materialelor de referinta                     |
|____|_________________________|_______________________________________________|
|204.| SR EN ISO 10993-13:2003 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 13: Identificare si cuantificare a     |
|    |                         | produselor de degradare din dispozitive       |
|    |                         | medicale pe baza de polimeri                  |
|____|_________________________|_______________________________________________|
|205.| SR EN ISO 10993-14:2003 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 14: Identificarea si cuantificarea     |
|    |                         | produselor de degradare din ceramica          |
|____|_________________________|_______________________________________________|
|206.| SR EN ISO 10993-15:2002 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 15: Identificare si cuantificare a     |
|    |                         | produsilor de degradare din metale si aliaje  |
|____|_________________________|_______________________________________________|
|207.| SR EN ISO 10993-16:2003 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 16: Proiectarea studiilor              |
|    |                         | toxicocinetice pentru produse de degradare si |
|    |                         | substante extractibile                        |
|____|_________________________|_______________________________________________|
|208.| SR EN ISO 10993-17:2003 | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 17: Stabilirea limitelor admisibile    |
|    |                         | pentru substante extractibile                 |
|____|_________________________|_______________________________________________|
|209.| SR EN ISO 10993-4:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 4: Selectarea testelor pentru          |
|    |                         | interactiunile cu sangele                     |
|____|_________________________|_______________________________________________|
|210.| SR EN ISO 10993-5:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 5: Teste pentru citotoxicitate in vitro|
|____|_________________________|_______________________________________________|
|211.| SR EN ISO 10993-7:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 7: Reziduuri de sterilizare cu oxid de |
|    |                         | etilena                                       |
|____|_________________________|_______________________________________________|
|212.| SR EN ISO 10993-8:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 8: Selectarea si calificarea           |
|    |                         | materialelor de referinta utilizate pentru    |
|    |                         | teste biologice                               |
|____|_________________________|_______________________________________________|
|213.| SR EN ISO 10993-9:2003  | Evaluarea biologica a dispozitivelor medicale.|
|    |                         | Partea 9: Cadru pentru identificarea si       |
|    |                         | cuantificarea produsilor potentiali de        |
|    |                         | degradare                                     |
|____|_________________________|_______________________________________________|
|214.| SR EN ISO 11196:2003    | Monitoare de gaz pentru anestezie             |
|____|_________________________|_______________________________________________|
|215.| SR EN ISO 11810:2003    | Optica si instrumente optice. Laseri si       |
|    |                         | echipamente cu laseri. Metode de verificare a |
|    |                         | rezistentei la radiatia laser a tesaturilor   |
|    |                         | chirurgicale si/sau a materialelor de         |
|    |                         | protectie a pacientilor                       |
|____|_________________________|_______________________________________________|
|216.| SR EN ISO 11990:2003    | Optica si instrumente optice. Laseri si       |
|    |                         | echipamente asociate laserilor. Determinarea  |
|    |                         | rezistentei la laser a tuburilor traheice     |
|____|_________________________|_______________________________________________|
|217.| SR EN ISO 12870:2003    | Optica oftalmica. Rame de ochelari. Cerinte   |
|    |                         | generale si metode de verificare              |
|____|_________________________|_______________________________________________|
|218.| SR EN ISO 13485:2003    | Sistemul calitatii. Dispozitive medicale.     |
|    |                         | Cerinte particulare pentru aplicare           |
|    |                         | EN ISO 9001 (revizuire a EN 46001:1996)       |
|____|_________________________|_______________________________________________|
|219.| SR EN ISO 13488:2002    | Sistemele calitatii. Dispozitive medicale.    |
|    |                         | Cerinte particulare pentru aplicarea          |
|    |                         | EN ISO 9002 (revizuire a EN 46002:1996)       |
|    |                         | (identic cu ISO 13488:1996)                   |
|____|_________________________|_______________________________________________|
|220.| SR EN ISO 14155-1:2003  | Investigatia clinica a dispozitivelor medicale|
|    |                         | pentru subiecti umani. Partea 1: Cerinte      |
|    |                         | generale                                      |
|____|_________________________|_______________________________________________|
|221.| SR EN ISO 14160:2003    | Sterilizarea dispozitivelor medicale de unica |
|    |                         | utilizare cu continut de materiale de origine |
|    |                         | animala. Validare si control de rutina a      |
|    |                         | sterilizarii prin agenti de sterilizare       |
|    |                         | chimici lichizi                               |
|____|_________________________|_______________________________________________|
|222.| SR EN ISO 14534:2003    | Optica oftalmica. Lentile de contact si       |
|    |                         | produse pentru intretinerea lentilelor de     |
|    |                         | contact. Cerinte fundamentale                 |
|____|_________________________|_______________________________________________|
|223.| SR EN ISO 14602:2001    | Implanturi chirurgicale neactive. Implanturi  |
|    |                         | pentru osteosinteza. Cerinte particulare      |
|____|_________________________|_______________________________________________|
|224.| SR EN ISO 14630:2000    | Implanturi chirurgicale neactive. Cerinte     |
|    |                         | generale                                      |
|____|_________________________|_______________________________________________|
|225.| SR EN ISO 14889:2003    | Optica oftalmica. Lentile de ochelari. Cerinte|
|    |                         | fundamentale pentru lentilele finisate,       |
|    |                         | nedebordate pe contur                         |
|____|_________________________|_______________________________________________|
|226.| SR EN ISO 14937:2003    | Sterilizarea produselor medicale pentru       |
|    |                         | ingrijirea sanatatii. Cerinte generale pentru |
|    |                         | caracterizarea agentului de sterilizare,      |
|    |                         | desfasurarea, validarea si controlul de rutina|
|    |                         | al proceselor de sterilizare pentru           |
|    |                         | dispozitivele medicale                        |
|____|_________________________|_______________________________________________|
|227.| SR EN ISO 14971:2003    | Dispozitive medicale. Aplicarea gestiunii     |
|    |                         | riscului la dispozitive medicale              |
|____|_________________________|_______________________________________________|
|228.| SR EN ISO 15004:2003    | Instrumente oftalmice. Cerinte de baza si     |
|    |                         | metode de verificare                          |
|____|_________________________|_______________________________________________|
|229.| SR EN ISO 15225:2002    | Nomenclatura. Specificatii pentru un sistem de|
|    |                         | nomenclatura pentru dispozitive medicale,     |
|    |                         | destinat schimbului de date de reglementare   |
|____|_________________________|_______________________________________________|
|230.| SR EN ISO 17510-2:2003  | Terapia respiratorie pentru apneea din timpul |
|    |                         | somnului. Partea 2: Masti si accesorii        |
|    |                         | terapeutice                                   |
|____|_________________________|_______________________________________________|
|231.| SR EN ISO 4074:2003     | Prezervative din latex de cauciuc natural.    |
|    |                         | Cerinte si metode de incercare                |
|____|_________________________|_______________________________________________|
|232.| SR EN ISO 4135:2003     | Echipament de anestezie si reanimare          |
|    |                         | respiratorie. Vocabular                       |
|____|_________________________|_______________________________________________|
|233.| SR EN ISO 8185:2003     | Umidificatoare medicale. Cerinte generale     |
|    |                         | pentru sistemele de umidificare               |
|____|_________________________|_______________________________________________|
|234.| SR EN ISO 8359:2002     | Concentratoare de oxigen pentru uz medical.   |
|    |                         | Cerinte de securitate                         |
|____|_________________________|_______________________________________________|
|235.| SR EN ISO 9360-1:2002   | Echipament de anestezie si de reanimare       |
|    |                         | respiratorie. Schimbatoare de caldura si      |
|    |                         | umiditate (HMEs) pentru umidificarea gazelor  |
|    |                         | respirate de fiinte umane. Partea 1: HMEs     |
|    |                         | pentru utilizare cu volume de aer pentru      |
|    |                         | respirat de minimum 250 ml                    |
|____|_________________________|_______________________________________________|
|236.| SR EN ISO 9360-2:2003   | Echipament de anestezie si reanimare          |
|    |                         | respiratorie. Schimbatoare de caldura si      |
|    |                         | umiditate (HMEs) pentru umidificarea gazelor  |
|    |                         | respirate de fiinte umane. Partea 2: (HMEs) cu|
|    |                         | volume de aer pentru respirat de minimum      |
|    |                         | 250 ml pentru pacienti cu traheostomie        |
|____|_________________________|_______________________________________________|
|237.| SR EN ISO 9703-3:2003   | Semnale de alarma pentru anestezie si         |
|    |                         | ingrijiri medicale. Partea 3: Ghid pentru     |
|    |                         | aplicarea alarmelor                           |
|____|_________________________|_______________________________________________|