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

SC 62A

Common aspects of electrical equipment used in medical practice

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62AJWG 1Mr Jos C.W. Van VroonhovenPPUB2020-072023

History

Stage
Document
Downloads
Decision Date
Target Date
ACD
62A/1189/RR PDF file 103 kB
2017-04-21 
CD
62A/1230/CD
PDF file 1683 kB
2017-12-082017-11
PCC
2018-03-022018-03
ACD
62A/1265/CC PDF file 2715 kB
Word file 318 kB
2018-03-232018-06
ACD
62A/1265A/CC PDF file 2249 kB
Word file 349 kB
2018-03-232018-06
CD
62A/1284/CD PDF file 1385 kB

2018-07-202018-07
PCC
2018-10-122018-10
CDM
62A/1297/CC PDF file 3707 kB
Word file 1727 kB
2018-10-192019-01
ADTR
62A/1297A/CC PDF file 3917 kB
Word file 1820 kB
2019-04-262019-05
CDTR
62A/1331/DTR
2019-05-102019-05
PRVDTR
2019-07-052019-07
APUB
62A/1345/RVDTR PDF file 1811 kB
Word file 369 kB
2019-07-122019-12
APUB
62A/1345A/RVDTR PDF file 1196 kB
Word file 399 kB
2019-07-122019-12
BPUB
2020-06-182019-12
PPUB
2020-06-192020-07
  

Abstract

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 - Medical devices - A practical guide.

Project

ISO TR 24971:2020 ED2

Medical devices - Guidance on the application of ISO 14971