British Standards Institution

Sector: Governance & Resilience

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 (3)

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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 24971-2	Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence Categories: Unclassified documents Drafting begins : 2024-11-18	Drafting
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)

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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)

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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

Message Committee Become a committee member

Committee members

Nominating organizations

7TP Consultancy Ltd
A B H I - Association of British Healthcare Industries
A C B I - Association of Consultants to the Bioscience Industries
Alvotech
AXREM
B S S - British Standards Society
BAREMA
Chartered Quality Institute
Committee Manager
G A M B I C A Association Limited
M H R A - Medicines and Healthcare products Regulatory Agency
N H S
Pfizer Limited
Red Medtech Ltd
Sheffmed
TidalSense

Liaisons with other committees

Individual Capacity - Expert in Polymer Materials
Individual Capacity - Exponent (Engeneering and Science Consulting)
Individual capacity - MD regulation and biomedical materials science
Individual Capacity - Medical systems engineering
Individual Capacity - Orthopaedic Implants
Individual Capacity - QARA Consultant
Individual Capacity - QMS auditing and human factors/usability testing
Individual Capacity - Risk Management for Electronic Medical Devices
Individual Capacity - Smith & Nephew
Individual Capacity - Software and Systems Expert
Individual Capacity – Expertise in QMS/MDSAP, design controls
Individual capacity – In-vitro diagnostics devices
Individual Capacity – risk management of medical devices
Individual capacity – Risk Management, regulatory affairs (EU/UK)
Individual Capacity – SME in Risk Management for MD
Liaison - AMT/10
Liaison - CH/194

BSI roles

Committee Chair

Standards Development

CH/210/4 - Risk analysis for Medical Devices

Committee standards activity