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CH/62 - Medical equipment, software, and systems

Sector: Governance & Resilience

Categories: | Luminaires | Syringes, needles and catheters | Medical equipment.Therapy | Medical equipment. Diagnostic | IT applications. Health care technology | Medical equipment | Hospital equipment | Laboratory medicine | Mathematics | Medical equipment. Radiographic | Metrology and measurement. | 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 (16)
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
New Work Item Proposal - VDE V 0750-2-52:2021-10 (MOD Medical electrical equipment - Requirements for the basic safety an essential performance of couches

Categories: Information management | Standardization. General rules

Proposal begins : 2025-07-23 		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
Published (1)
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)
Reference Standards description
Status ?

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