CENELEC
Project
| Reference | EN 60601-1:1990/A2:1995 |
|---|---|
| Title | Medical electrical equipment - Part 1: General requirements for safety |
| Project Number | 4205 |
| 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Withdrawn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 | 1995-06-16 |
| Current Stage code deadline | 1996-03-01 |
| Deadline date for vote |
Legal
| Directive(s) | AIMD (90/385/EEC), MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1:1988/A2:1995 (EQV) + corrigendum Jun. 1995 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Safety |
| Note | EN following parallel vote * Incorporates and supersedes A11 and A12 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|---|---|---|
| 6.8.2.j | Waste - Hazardous waste | Disposal | B2B, B2C |
History
Implementation Dates
| date of Ratification (DOR) (1) | 1995-03-06 |
|---|---|
| date of Availability (DAV) (2) | 1995-06-16 |
| date of Announcement (DOA) (3) | 1995-06-01 |
| date of Publication (DOP) (4) | 1996-03-01 |
| date of Withdrawal (DOW) (5) | 2012-06-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | EN 60601-1:2006 |
| Normative reference (6) | ISO 471:1983 ISO 1000:1981 ISO 1853:1975 ISO 2878:1987 ISO 2882:1979 ISO 8185:1988 ISO R 32:1977 ISO 10993-1:1992 EN 60065:1993 corr. November 1993 corr. September 1997 A11:1997 EN 60068-2-2:1993 HD 354 S2:1987 IEC 60079-2:1983 IEC 60079-5:1967 IEC 60079-6:1968 HD 566 S1:1990 HD 214 S2:1980 HD 109 S3:1983 HD 21.1 S2:1990 A8:1994 A6:1991 A7:1992 A5:1990 A9:1993 A12:1993 A15:1995 A13:1994 A16:1995 A14:1997 IEC 60241:1968 HD 22.4 S2:1992 A6:1992 IEC 60252:1975 EN 60320-1:1987 corr. November 1993 A11:1994 IEC 60328:1972 IEC 60335-1:1970 IEC 60364-4-41:1982 IEC 60384-14:1993 HD 243 S12:1995 corr. October 1995 HD 241 S2:1977 HD 331 S1:1977 IEC 60513:1994 EN 60529:1991 corr. May 1993 HD 366 S1:1977 HD 395.1 S2:1988 A1:1993 EN 60601-1-1:1993 EN 60601-1-2:1993 corr. December 1997 EN 60601-1-3:1994 EN 60601-1-4:1996 IEC 60664:1980 IEC 60695-1-1:1982 HD 441 S1:1983 EN 60742:1995 IEC 60878:1988 ISO R 407:1983 ISO R 780:1985 |
(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.
