British Standards Institution

Sector: Governance & Resilience

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 (17)

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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.
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 : 2024-09-11	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
IEC/PWI TS 62366-2	Medical devices — Part 2: Guidance on the application of usability engineering to medical devices Categories: Information management \| Standardization. General rules Proposal begins : 2024-01-19	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

Published (3)

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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 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 (4)

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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 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 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

Standards Development

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

Committee standards activity