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CH/210/4 - Risk management and post market surveillance for medical devices

Sector: Governance & Resilience

Categories: Quality management and quality assurance | Medical sciences and health care facilities. General | Laboratory medicine | Standardization. General rules | | Information technology. General | Medical equipment. General

Overview: Under the direction of CH/210 is responsible for UK input into CEN/CLC TC 3, ISO/TC 210/WG 6, ISO/TC 210/JWG 1, ISO/TC 210/ JWG 3, and the preparation, revision and amendment of British Standards in the field of risk management and post market surveillance for medical devices.

Committee standards activity

In Progress (7)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 24971-3 Medical devices - Guidance on the application of ISO 14971. Part 3: Combination products

Categories: Unclassified documents

Proposal begins : 		Proposal
PD ISO/TS 24971-2 Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

Categories: Medical equipment. General | Information technology applications. General | IT applications. Health care technology

Approval begins : 		Approval
PD ISO/TR 20416 Medical devices — Post-market surveillance for manufacturers

Categories: Unclassified documents

Proposal begins : 		Proposal
ISO/NP TS 25694 - Risk Management for Combination Products

Categories: Information management | Standardization. General rules

Proposal begins : 2025-01-15 		Proposal
CEN/CLC/JTC 3 N 601, Medical devices - Application of risk management to medical devices

Categories: Information management | Standardization. General rules | Business | Quality | Quality management and quality assurance | Healthcare | Medical sciences and health care facilities. General | Medical equipment | Laboratory medicine

Proposal begins : 2021-06-01 		Proposal
BS EN ISO 14971:2019 Medical devices -- Application of risk management to medical devices

Categories: Medical equipment. General

Approval begins : 2019-07-05 		Approval
62/540/NP - Post-market surveillance of machine learning-enabled medical device

Categories: Information management | Standardization. General rules

Proposal begins : 2025-02-04 		Proposal
Published (8)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Categories: Standardization. General rules | Medical equipment. General

Published standard begins : 2019-08-21 		Published standard
PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971

Categories: Medical equipment. General

Published standard begins : 2020-06-19 		Published standard
PD CEN ISO/TR 20416:2020 Medical devices. Post-market surveillance for manufacturers

Categories: Medical equipment. General

Published standard begins : 2020-08-19 		Published standard
BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence. Guide

Categories: Medical equipment. General | Information technology. General

Published standard begins : 2023-05-30 		Published standard
BS EN ISO 14971:2019+A11:2021 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General

Published standard begins : 2021-12-15 		Published standard
BS EN ISO 14971:2001 BS EN ISO 14971 Medical devices - Application of risk management to medical devices

Categories: Laboratory medicine | Medical equipment. General

Published standard begins : 2001-02-13 		Published standard
AMD 14652 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General | Laboratory medicine

Published standard begins : 2003-08-18 		Published standard
AMD 14456 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General | Laboratory medicine

Published standard begins : 2003-07-02 		Published standard
Withdrawn (5)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TR 24971:2013 Medical devices. Guidance on the application of ISO 14971

Categories: Medical equipment. General

Withdrawn begins : 2020-06-19 		Withdrawn
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General

Withdrawn begins : 2021-12-15 		Withdrawn
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General

Withdrawn begins : 2019-12-18 		Withdrawn
BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General

Withdrawn begins : 2011-02-07 		Withdrawn
BS EN ISO 14971:2007 Medical devices. Application of risk management to medical devices

Categories: Medical equipment. General

Withdrawn begins : 2009-07-28 		Withdrawn