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/WG 1 and the preparation, revision and amendment of British Standards in the field of quality systems for medical devices.

Committee standards activity

In Progress (1)

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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.
ISO/NP TS 25502	Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016 Categories: Information management \| Standardization. General rules Proposal begins : 2024-10-16	Proposal

Published (1)

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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 14969:2004	Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 Categories: Quality management and quality assurance \| Medical equipment. General Published standard begins : 2004-11-02	Published standard

Withdrawn (7)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.
BS EN ISO 13488:2001	Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002 Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2006-07-04	Withdrawn
BS EN ISO 13485:2016	Medical devices. Quality management systems. Requirements for regulatory purposes Categories: \| Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2016-03-01	Withdrawn
BS EN ISO 13485:2012	Medical devices. Quality management systems. Requirements for regulatory purposes Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2012-09-17	Withdrawn
BS EN ISO 13485:2003	Medical devices. Quality management systems. Requirements for regulatory purposes Categories: Medical equipment. General \| Quality management and quality assurance Withdrawn begins : 2008-01-14	Withdrawn
BS EN ISO 13485:2001	Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001 Categories: Medical equipment. General \| Quality management and quality assurance Withdrawn begins : 2006-07-04	Withdrawn
BS EN 46003:1999	Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003 Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2008-01-14	Withdrawn
AMD 15958	PDCENISO/TR14969 : 2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2016-05-24	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
Association of Contact Lens Manufacturers
AXREM
BAREMA
BSI Regulatory Services
Cogent Technologies
CoMind Technologies Limited
Committee Manager
Hardian Health
I P E M - Institute of Physics and Engineering in Medicine
Invibio Device Components Manufacturing Limited
JensonR+ Ltd
M H R A - Medicines and Healthcare products Regulatory Agency
Medical Engineering Technologies
Pfizer Limited
Red Medtech Ltd
Sheffmed
Surgical Dressings Manufacturers Association

Liaisons with other committees

Individual Capacity - Brightwake
Individual Capacity - Expert in Polymer Materials
Individual Capacity - Exponent (Engeneering and Science Consulting)
Individual Capacity - Implementing Quality Management Systems
Individual Capacity - NSF Health
Individual Capacity - Orthopaedic Implants
Individual Capacity - QARA Consultant
Individual Capacity - QMS auditing and human factors/usability testing
Individual Capacity - QMS Expert
Individual Capacity - Quality Management
Individual Capacity - Software and Systems Expert
Individual Capacity - User experience design and evaluation
Individual Capacity – Expertise in QMS/MDSAP, design controls

BSI roles

Committee Chair

Standards Development

CH/210/1 - Quality systems for medical devices

Committee standards activity