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CH/62/4 - Particular medical equipment, software, and systems

Sector: Governance & Resilience

Categories: Electromagnetic compatibility. General | Electroacoustics | Pumps and motors | Switchgear and controlgear. High voltage | Luminaires | Wind turbine energy systems | Syringes, needles and catheters | Optoelectronics. Laser equipment | Fuses. Overcurrent protection devices | Fuel cells | Medical equipment.Therapy | Application layer | Emission | Medical equipment. Diagnostic | Medical equipment | Resistors. Fixed | Hospital equipment | Printed circuits and boards | Radiation protection | Fibres and cables | Medical equipment. Radiographic | Fibre optic interconnecting devices | | Audio, video and audiovisual systems. General | Multilayer applications | Screw threads. General | Medical equipment. Ophthalmic | | Electronic components. General | Information technology. General | Electronic display devices | Hydraulic energy engineering | Electromechanical components. General | Housings, enclosures, other machine parts | Medical equipment. General | Plug-and-socket devices. Connectors | Transport layer | Medical equipment. Other | Surgical instruments and materials | Industrial process measurement and control | Components. Electrical equipment. General | Transfusion, infusion and injection equipment | Electrical engineering | Anaesthetic, respiratory and reanimation equipment | Railway rolling stock. General | Ships and marine structures. Electrical equipment | Electrical engineering. General

Overview: Under the direction of CH/62 is responsible for UK input into IEC/SC 62D, the preparation, of particular British standards and other publications to support safety and performance for medical equipment, software, and systems. Excluded are medical imaging and related equipment (see scope of CH/62/2) and medical equipment using ionizing radiation in therapy (see scope of CH/62/3).

Committee standards activity

In Progress (30)
Reference Standards description
Status ?

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

PNW TS 87-849 ED1: Ultrasonics Field characterization Measurement-based simulation in water and other media

Categories: Information management | Standardization. General rules

Proposal begins : 2024-02-22
Proposal
PNW TS 87-848 ED1: Ultrasonics Field characterization Specification and measurement of field parameters at high pressure therapeutic levels in water

Categories: Information management | Standardization. General rules

Proposal begins : 2024-02-22
Proposal
PD IEC/TR 63577 ED1 Design principles and validation methods for the maintenance of microbial control for non-disposable fluid paths of dialysis equipment

Categories: Unclassified documents

Public comment begins :
Public comment
PD IEC/TR 62653 Ed.3.0 Guideline for safe operation of medical equipment used for haemodialysis treatments

Categories: Unclassified documents

Drafting begins : 2023-02-01
Drafting
PD IEC/TR 61289 Amd.1 Ed.2.0 Amendment 1 - High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

Categories: Unclassified documents

Drafting begins : 2024-11-22
Drafting
IEC 62D/2181/NP N 439 Medical electrical equipment – Part 2-xx: Particular requirements for the basic safety and essential performance for continuous glucose monitoring system

Categories: Information management | Standardization. General rules

Proposal begins : 2024-11-05
Proposal
IEC 62D/2175/NP Non-invasive sphygmomanometers -- Part 7: Part 7: Clinical performance verification of intermittent or repeated intermittent cuffless measurement type

Categories: Information management | Standardization. General rules

Proposal begins : 2024-10-01
Proposal
IEC 61/6807/NP Particular requirements for breast pumps for expressing breast milk

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

Proposal begins : 2023-02-23
Proposal
BS EN IEC 80601-2-89 Medical electrical equipment. - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

Categories: Medical equipment. General | Hospital equipment

Comment resolution begins : 2024-12-23
Comment resolution
BS EN IEC 80601-2-71 BS EN 80601-2-71 Ed.2.0 Medical electrical equipment. Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

Categories: Medical equipment. Diagnostic

Approval begins : 2024-10-31
Approval
Published (46)
Reference Standards description
Status ?

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

PD IEC/PAS 63023:2016 Medical electrical system. Input interface for haemodialysis equipment for use of external alarming device

Categories: Transfusion, infusion and injection equipment

Published standard begins : 2016-02-18
Published standard
PD IEC TR 61289:2019 High frequency surgical equipment and high frequency surgical accessories. Operation and maintenance

Categories: Medical equipment. General

Published standard begins : 2019-05-13
Published standard
BS EN IEC 80601-2-78:2020+A1:2024 Medical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Categories: Medical equipment. General

Published standard begins : 2024-09-26
Published standard
BS EN IEC 80601-2-78:2020 Medical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Categories: Medical equipment. General

Published standard begins : 2020-04-06
Published standard
BS EN IEC 80601-2-77:2021+A1:2023 Medical electrical equipment. Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Categories: Medical equipment. General | Surgical instruments and materials

Published standard begins : 2024-01-02
Published standard
BS EN IEC 80601-2-71:2018 Medical electrical equipment. Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

Categories: Medical equipment. Diagnostic

Published standard begins : 2018-06-29
Published standard
BS EN IEC 80601-2-58:2024 Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

Categories: Medical equipment. Ophthalmic

Published standard begins : 2024-09-26
Published standard
BS EN IEC 80601-2-49:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Categories: Medical equipment. Diagnostic

Published standard begins : 2019-10-14
Published standard
BS EN IEC 80601-2-49:2018+A1:2024 Medical electrical equipment. Particular requirements for the basic safety and essential performance of multifunction patient monitors

Categories: Medical equipment. Diagnostic

Published standard begins : 2024-10-22
Published standard
BS EN IEC 80601-2-30:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Categories: Medical equipment. General | Medical equipment. Diagnostic

Published standard begins : 2019-07-03
Published standard
Withdrawn (62)
Reference Standards description
Status ?

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

BS IEC 80601-2-77:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Categories: Medical equipment. General | Surgical instruments and materials

Withdrawn begins : 2021-10-14
Withdrawn
BS EN IEC 80601-2-59:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

Categories: Medical equipment. Diagnostic

Withdrawn begins : 2023-02-27
Withdrawn
BS EN IEC 80601-2-26:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs

Categories: Medical equipment. General | Medical equipment. Diagnostic | Medical equipment. Other

Withdrawn begins : 2021-11-05
Withdrawn
BS EN IEC 60601-2-83:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of home light therapy equipment

Categories: Medical equipment.Therapy

Withdrawn begins : 2023-12-06
Withdrawn
BS EN IEC 60601-2-76:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

Categories: Medical equipment. General

Withdrawn begins : 2023-10-11
Withdrawn
BS EN IEC 60601-2-50:2021 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Categories: Medical equipment.Therapy

Withdrawn begins : 2023-12-14
Withdrawn
BS EN IEC 60601-2-35:2021 Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Categories: Medical equipment. General

Withdrawn begins : 2024-01-30
Withdrawn
BS EN IEC 60601-2-21:2021 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant radiant warmers

Categories: Anaesthetic, respiratory and reanimation equipment

Withdrawn begins : 2024-01-10
Withdrawn
BS EN IEC 60601-2-20:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant transport incubators

Categories: Anaesthetic, respiratory and reanimation equipment

Withdrawn begins : 2023-12-18
Withdrawn
BS EN IEC 60601-2-19:2021 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators

Categories: Anaesthetic, respiratory and reanimation equipment

Withdrawn begins : 2024-01-15
Withdrawn