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CH/210/1 - Quality management systems for medical devices

Sector: Governance & Resilience

Categories: Quality management and quality assurance | Medical equipment | Hospital equipment | | | In vitro diagnostic test systems | Medical equipment. General | Surgical instruments and materials

Overview: Under the direction of CH/210 is responsible for UK input into CEN/CLC TC 3, ISO/TC 210/WG 1 and ISO/TC 210/JWG 2 and the preparation, revision and amendment of British Standards in the field of quality management systems for medical devices.

Committee standards activity

In Progress (1)
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 23485 Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016

Categories: Unclassified documents

Drafting begins : 2026-02-25 		Drafting
Published (1)
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Withdrawn (7)
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Withdrawn begins : 2006-07-04 		Withdrawn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Withdrawn begins : 2016-03-01 		Withdrawn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Withdrawn begins : 2012-09-17 		Withdrawn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: Quality management and quality assurance | Medical equipment. General

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