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CH/210 - Quality management and corresponding general aspects for medical devices

Sector: Governance & Resilience

Categories: Quality management and quality assurance | Syringes, needles and catheters | Graphical symbols. Specific equipment | Purchasing. Procurement. Logistics | Medical equipment | Technical product documentation | Pharmaceutics. General | | Medical equipment. General | Transfusion, infusion and injection equipment | Anaesthetic, respiratory and reanimation equipment

Overview: Under the direction of the Standards Policy and Strategy Committee is responsible for UK input into ISO/TC 210, CEN/CLC JTC 3 and CEN- CENELEC/SAG on Healthcare Standards and the preparation, revision and amendment of British Standards in the field of quality management, risk management and particular aspects of sustainability relating to healthcare.

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.
BS ISO 5137 Maintenance management program for medical equipment

Categories: Medical equipment. General

Drafting begins : 2023-02-28 		Drafting
BS EN ISO 15223-1:2016/A Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements

Categories: Graphical symbols. Specific equipment | Medical equipment. General

Approval begins : 2021-02-12 		Approval
Published (3)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Categories: | Medical equipment. General

Published standard begins : 2018-03-21 		Published standard
BS EN ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications. Connectors for intravascular or hypodermic applications

Categories: Syringes, needles and catheters

Published standard begins : 2021-05-24 		Published standard
BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes

Categories: | Quality management and quality assurance | Medical equipment. General

Published standard begins : 2021-09-08 		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 16142:2006 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Categories: Medical equipment. General

Withdrawn begins : 2016-03-17 		Withdrawn
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

Categories: Medical equipment. General

Withdrawn begins : 2024-07-03 		Withdrawn
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

Categories: Medical equipment. General

Withdrawn begins : 2016-03-17 		Withdrawn
BS EN ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications. Connectors for respiratory applications

Categories: Anaesthetic, respiratory and reanimation equipment | Transfusion, infusion and injection equipment

Withdrawn begins : 2025-06-23 		Withdrawn
BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer

Categories: Technical product documentation | Medical equipment. General | Pharmaceutics. General

Withdrawn begins : 2022-05-27 		Withdrawn