CENELEC
Project
| Reference | EN 60601-1-4:1996 |
|---|---|
| Title | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems |
| Project Number | 5696 |
| Abstract/Scope | Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. |
| Status |
Withdrawn
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1996-09-30 |
| Current Stage code deadline | 1997-04-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/023; M/432 |
| Order Voucher | BC/CLC/93-01 |
Details
| IEC Technical Body | IEC/TC 62 |
|---|---|
| Reference Document | IEC 60601-1-4:1996 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical equipment; Programmable electrical medical system; Safety |
| Note | EN following parallel vote |
| 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) | 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 |
Relations
| 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| Superseded by | EN 60601-1:2006 |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.
