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

 

Project

Reference EN 62366:2008/FprA1:2013
Title Medical devices - Application of usability engineering to medical devices
Project Number 24463
Abstract/Scope Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2014-02-11
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC), LVD (2006/95/EC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 62366:2007/A1:2014 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical; Usability engineering
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2014-02-11    
5060 2013-09-16 2013-10-07 export to doc file  EN
5020 2013-07-12 2013-09-13  
3090 2013-07-09 2013-07-12  
5060 2013-01-14 2013-02-04 export to doc file  EN
5020 2012-09-28 2013-01-11  
1090 2012-09-25 2012-09-28  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) dor + 3 months
date of Publication (DOP) (4) dor + 9 months
date of Withdrawal (DOW) (5) dor + 36 months

Relations

Supersedes  
Superseded by  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.