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

CEN/CLC/TC 3

Management de la qualité et aspects généraux correspondants relatifs aux dispositifs médicaux

 

Projet

Reference EN ISO 14971:2009
Title Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
Project Number 22260
Abstract/Scope  
Status
Withdrawn

Statut

Current Stage code 6060
Current Stage code date 2009-07-15
Current Stage code deadline 2010-01-31
Deadline date for vote  

Légal

Directive(s) MDD (93/42/EEC), AIMD (90/385/EEC)
Mandate(s)  
Order Voucher  

Détails

IEC Technical Body IEC/SC 62A
Reference Document ISO 14971:2007 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords  
Note Project under CEN lead * Document circulated to CENELEC members for information purposes * Previous edition published with CEN logo only (March 2007)
A-Deviation(s)  
Special National Condition(s)  

Environnement

Clause
Categories - Aspects
Cycle de vie du produit
Information

Histoire

Stage
Date
Deadline Date
Documents
6060 2009-07-15 2010-01-31 export to doc file  EN  FR  DE
5099 2009-06-13 2009-10-13  
5021 2009-02-12 2009-05-12  

Dates de mise en application

date of Ratification (DOR) (1) 2009-06-13
date of Availability (DAV) (2) 2009-07-15
date of Announcement (DOA) (3) 2009-10-31
date of Publication (DOP) (4) 2010-01-31
date of Withdrawal (DOW) (5) 2010-03-21

Rélations

Supersedes EN ISO 14971:2000
EN ISO 14971:2000/A1:2003
Superseded by EN ISO 14971:2012
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Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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.