CENELEC
CLC/TC 62 |
Equipements électriques dans la pratique médicale |
Projet
| Reference | EN 60601-1-4:1996 |
|---|---|
| Title | Appareils électromédicaux - Partie 1-4: Règles générales de sécurité - Norme collatérale: Systèmes électromédicaux programmables |
| Project Number | 5696 |
| Abstract/Scope | Cette norme fixe les prescriptions à suivre lors de la conception d'un système électromédical programmable. Elle fournit aussi la base des prescriptions des normes particulières en servant de guide pour les exigences de sécurité visant à réduire et à gérer les risques. Elle traite les aspects suivants : les spécifications des prescriptions, l'architecture, la conception détaillée et la mise en oeuvre y compris le développement du logiciel, les modifications, la vérification et la validation, le marquage et les documents d'accompagnement. |
| Status |
Withdrawn
|
Statut
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1996-09-30 |
| Current Stage code deadline | 1997-04-01 |
| Deadline date for vote |
Légal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/023; M/432 |
| Order Voucher | BC/CLC/93-01 |
Détails
| IEC Technical Body | IEC/TC 62 |
|---|---|
| Reference Document | IEC 60601-1-4:1996 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | |
| Note | EN following parallel vote |
| A-Deviation(s) | |
| Special National Condition(s) |
Environnement
|
Clause
|
Categories - Aspects
|
Cycle de vie du produit
|
Information
|
|---|
Histoire
Dates de mise en application
| date of Ratification (DOR) (1) | 1996-07-02 |
|---|---|
| date of Availability (DAV) (2) | 1996-09-30 |
| date of Announcement (DOA) (3) | 1996-10-01 |
| date of Publication (DOP) (4) | 1997-04-01 |
| date of Withdrawal (DOW) (5) | 1997-04-01 |
Rélations
| Supersedes | |
|---|---|
| Superseded by | EN 60601-1:2006 |
| Normative reference (6) | ISO 9000-3:1991 ISO 9001:1994 EN 60601-1:1990 corr. July 1994 A1:1993 A2:1995 A11:1993 A12:1993 A13:1996 EN 60601-1-1:1993 HD 501 S1:1988 |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
