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

 

Project

Reference prEN ISO 14971
Title Medical devices - Application of risk management to medical devices
Project Number 17051
Abstract/Scope  
Status
Enquiry stage

Status

Current Stage code 4098
Current Stage code date 2006-12-08
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document ISO 14971:2007 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords Medical devices; Risk management
Note Work stopped to avoid overlap with CEN (Reference document confirmed as an ISO standard * Parallel procedure originally launched because first edition of Reference Document, which was initially developed as an ISO/IEC draft, was parallel voted) * CEN standard EN ISO 14971 (ISO 14971:2007-02) published with single logo on 2007-03-15 (doa: 2007-06-30 / dop: 2007-09-30 / dow: 2010-03-31)
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
4098 2006-12-08    
4099 2006-06-16 2006-10-31  
4060 2006-03-01 2006-05-01 export to doc file  EN
4020 2005-09-23 2006-02-24  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) -
date of Publication (DOP) (4) -
date of Withdrawal (DOW) (5) -

Relations

Supersedes EN ISO 14971:2000
EN 14971:2000/corrigendum Feb. 2002
EN ISO 14971:2000/A1:2003
Superseded by  
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Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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.