CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |

Project
| Reference | EN 60601-1:1990 |
|---|---|
| Title | Medical electrical equipment - Part 1: General requirements for safety |
| Project Number | 4201 |
| Abstract/Scope | This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. lt also contains certain requirements for reliable operation to ensure safety. Note the change of title from the first (1977) edition. (For particular requirements see series 601-2 below.) |
| Status |
Withdrawn
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1990-08-09 |
| Current Stage code deadline | 1991-01-01 |
| Deadline date for vote |
Legal
| Directive(s) | AIMD (90/385/EEC), MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher | BC/CLC/09-89 |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1:1988 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Safety |
| Note | Supersedes HD 395.1 S2 * Corrigendum to EN issued July 1994 * Superseded by EN 60601-1:2006 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | 1990-06-11 |
|---|---|
| date of Availability (DAV) (2) | 1990-08-09 |
| date of Announcement (DOA) (3) | 1990-09-01 |
| date of Publication (DOP) (4) | 1991-01-01 |
| date of Withdrawal (DOW) (5) | 2012-06-01 |
Relations
| Supersedes | HD 395.1 S2:1988 HD 395.1 S2:1988/A1:1993 |
|---|---|
| Superseded by | EN 60601-1:2006 |
| Normative reference (6) |
(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.
