British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee is responsible for UK input into IEC/TC 62 and CENELEC/TC 62, the preparation of British Standards, and other publications, with focus on safety and performance of medical equipment, software, and systems. Note: CH/62 coordinates and addresses emerging technologies not previously covered in its subcommittees. CH/62/1 works on common aspects of medical equipment, software, and systems. Particular medical equipment, software, and systems are covered in CH/62/2, CH/62/3 and CH/62/4.

Committee standards activity

In Progress (14)

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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.
PNW TS SYCAAL-386 ED1:	Guidance for AAL services based on the smart speaker in connected home environment (CHE) Categories: Information management \| Standardization. General rules Proposal begins : 2025-02-25	Proposal
PNW TS SYCAAL-377 ED1:	Guidance for the development and implementation of Active Assisted Living (AAL) Systems and Services Categories: Information management \| Standardization. General rules Proposal begins : 2024-12-13	Proposal
PNW TS 62A-1543 ED1:	Medical electrical equipment - Part 4-X: Guidance and interpretation - Medical electrical equipment and medical electrical systems - Physiological and Anthropometric Characteristics for human and animal patients Categories: Information management \| Standardization. General rules Proposal begins : 2024-01-08	Proposal
PNW PAS 62-531 ED1:	Data management and data quality assessment for medical devices Categories: Information management \| Standardization. General rules Proposal begins : 2024-10-02	Proposal
PNW 62-540 ED1:	Post-market surveillance of machine learning-enabled medical device Categories: Information management \| Standardization. General rules Proposal begins : 2025-01-08	Proposal
PNW 62-393 ED1	International Electrotechnical Vocabulary (IEV) – Part XXX: Electrical equipment, electrical systems and software used in healthcare Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. Other \| ICT \| Information technology \| IT applications. Health care technology Proposal begins : 2021-09-09	Proposal
IEC SyCAAL/377/NP N 423	Guidance for the development and implementation of Active Assisted Living (AAL) Systems and Services Categories: Information management \| Standardization. General rules Proposal begins : 2024-12-16	Proposal
IEC 62A/1648/NP	Medical devices – Part 3: Guidance on the application of usability engineering to medical devices using artificial intelligence and machine learning technology Categories: Information management \| Standardization. General rules Proposal begins : 2025-03-10	Proposal
IEC 62A/1606/NP N 320	Packaging for non-sterile medical devices – Requirements for packaging systems Categories: Information management \| Standardization. General rules Proposal begins : 2024-07-10	Proposal
BS EN IEC 63521 ED1	BS EN 63521 ED1 Machine Learning-enabled Medical Device – Performance Evaluation Process Categories: Unclassified documents Drafting begins : 2025-05-23	Drafting

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 IEC TR 62653:2020	Guideline for safe operation of medical equipment used for haemodialysis treatments Categories: Transfusion, infusion and injection equipment \| Syringes, needles and catheters Published standard begins : 2020-04-20	Published standard

Withdrawn (0)

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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.

Message Committee Become a committee member

Committee members

Nominating organizations

AND Technology Research
AXREM
Buckinghamshire NHS Healthcare Trust
Committee Manager
ConvaTec Ltd
Ethos Ltd
Human Fertilisation & Embryology Authority (HFEA)
M H R A - Medicines and Healthcare products Regulatory Agency
The Christie NHS Foundation Trust
TUV SUD
University of Bath
University of Leeds
University of Manchester
University of Sheffield

Liaisons with other committees

Chair - CH/62/1
Chair - CH/62/3
Chair - CH/62/4
Individual Capacity - AI and software Life Cycle
Individual Capacity - Digital Health Assurance Expert
Individual Capacity - IEC 60601/80601 Series
Individual Capacity - Terminology Expert
Individual Capacity – AI, Software, Electro mechanical active devices
Liaison

BSI roles

Committee Chair

Standards Development

CH/62 - Medical equipment, software, and systems

Committee standards activity