British Standards Institution

Sector: Governance & Resilience

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 (6)

Show entries

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 : 2025-02-10	Drafting
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 (7)

Show entries

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
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 (6)

Show entries

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
BS EN ISO 14971:2001	Medical devices. Application of risk management to medical devices Categories: Medical equipment. General Withdrawn begins : 2007-04-11	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
AND Technology Research
AXREM
B S S - British Standards Society
BAREMA
Buckinghamshire NHS Healthcare Trust
Chartered Quality Institute
Committee Manager
Cqura
Ethos Ltd
G A M B I C A Association Limited
Human Fertilisation & Embryology Authority (HFEA)
Kinneir Dufort
Pfizer Limited
Red Medtech Ltd
Sheffmed
Teva Pharmaceutical Industries
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 – AI, Software, Electro mechanical active devices
Individual Capacity – Expertise in QMS/MDSAP, design controls
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 management and post market surveillance for medical devices

Committee standards activity