International Standards and Conformity Assessment for all electrical, electronic and related technologies

CLC/TC 62

Electrical equipment in medical practice

 

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
Published

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

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1996-09-30 1997-04-01 export to doc file  EN
6020 1996-08-02 1996-11-02  
5099 1996-07-02 1996-08-02  
5062 1996-05-13 1996-07-02  
5020 1996-02-23 1996-04-30  
1090 1996-02-21 1996-02-22  
1000 1993-08-31    

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Superseded by EN 60601-1:2006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.