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CH/210/4 - Risk analysis 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 and ISO/TC 210 - IEC/SC 62A/ JWG 1 and the preparation, revision and amendment of British Standards in the field of risk management for medical devices.

Committee standards activity

In Progress (2)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

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
Published (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/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
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 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