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CH/62 - Medical equipment, software, and systems

Sector: Governance & Resilience

Categories: | Luminaires | Syringes, needles and catheters | Medical sciences and health care facilities. General | Medical equipment.Therapy | Medical equipment. Diagnostic | IT applications. Health care technology | Medical equipment | Hospital equipment | Laboratory medicine | Mathematics | Medical equipment. Radiographic | Metrology and measurement. | Electrical equipment. Special conditions. General | Information technology. General | Mathematics. Natural sciences | Graphical symbols for use on electrical and electronics engineering drawings, diagrams, charts and in relevant technical product documentation | Medical equipment. General | Medical equipment. Other | Surgical instruments and materials | Software | 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 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 (29)
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 JTC1-SC43-183 ED1: Information technology - Brain-computer Interfaces - Testing and post market surveillance protocols for non-medical BCIs

Categories: Information management | Standardization. General rules

Proposal begins : 2025-11-05
Proposal
PNW TS 62A-1712 ED1: Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a level of autonomy

Categories: Information management | Standardization. General rules

Proposal begins : 2025-12-16
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 JTC1-SC43-179 ED1: Information technology – Brain- computer Interfaces - Hardware interfaces and protocols

Categories: Information management | Standardization. General rules

Proposal begins : 2025-10-01
Proposal
PNW 62-568 ED1: Management systems - Guidelines for incorporating ecodesign in the medical device sector

Categories: Information management | Standardization. General rules

Proposal begins : 2025-10-30
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
Published (2)
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
PD IEC PAS 63621:2026 Artificial intelligence enabled medical devices - Data management

Categories: Medical sciences and health care facilities. General | Medical equipment

Published standard begins : 2026-03-19
Published standard
Withdrawn (0)
Reference Standards description
Status ?

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