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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 CEN/CLC JTC 3, ISO/TC 210 and ISO/TC 210/WG 2 and the preparation, revision and amendment of British Standards in the field of quality for medical devices.

Committee standards activity

In Progress (15)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

XXXX Machine learning AI in medical devices: considerations for risk management

Categories: Information management | Standardization. General rules | Business | Quality | Quality management and quality assurance | Healthcare | Medical sciences and health care facilities. General | Medical equipment

Proposal begins : 2020-07-13
Proposal
XXXX Machine learning AI in medical devices: considerations for risk management

Categories: Information management | Standardization. General rules | Business | Quality | Quality management and quality assurance | Healthcare | Medical sciences and health care facilities. General | Medical equipment

Proposal begins : 2020-07-13
Proposal
PD ISO/TS 5137 Medical device maintenance management for healthcare delivery organizations

Categories: Unclassified documents

Drafting begins : 2024-09-18
Drafting
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
ISO/TC 210 N 899, ISO/NP TR 22740 Devices incorporating small-bore connectors-- recommended colour allocation for each application

Categories: Standardization. General rules | Quality | Quality management and quality assurance | Healthcare | Medical equipment | Hospital equipment

Proposal begins : 2019-07-01
Proposal
ISO/TC 210 N 1167, ISO/NP 5137 Active Medical Device - Good Engineering Maintenance Management

Categories: Information management | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. General | Medical equipment. Other

Proposal begins : 2020-03-25
Proposal
ISO/NP TS 23918 Medical devices -- Guidance on the application of ISO 14971 -- Part 2: Machine learning in artificial intelligence

Categories: Standardization. General rules | Quality | Quality management and quality assurance | Healthcare | Medical sciences and health care facilities. General | Medical equipment | ICT | Information technology | IT applications. Health care technology

Proposal begins : 2023-08-16
Proposal
Form 4: New Work Item Proposal, Consumer ncident investigation guideline with explanatory annex for submission rev2

Categories: Information management | Standardization. General rules | Business | Quality | Quality management and quality assurance | Healthcare | Medical sciences and health care facilities. General

Proposal begins : 2020-02-25
Proposal
BS ISO 5137 Maintenance management program for medical equipment

Categories: Medical equipment. General

Drafting begins : 2023-02-28
Drafting
BS EN ISO 80369-6 Small bore connectors for liquids and gases in healthcare applications —. Part 6: Connectors for neural applications

Categories: Syringes, needles and catheters

Public comment begins : 2023-08-11
Public comment
Published (5)
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 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

Published standard begins : 2024-08-28
Published standard
BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer

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

Published standard begins : 2021-04-13
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 (3)
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