British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/62 is responsible for UK input into IEC/SC 62B, the preparation of British standards and other publications to support safety and performance for all kind of medical diagnostic imaging equipment, software and systems as well as quality procedures (e.g., acceptance tests and constancy tests) to be applied during the life-time of imaging equipment. Excluded are radiotherapy and nuclear imaging for diagnostic purposes as covered by CH/62/3.

Committee standards activity

In Progress (11)

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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 62C-849 ED1:	Medical electrical equipment - Part 2-XX: Particular requirements for the basic safety and essential performance of MRI based image guided radiotherapy equipment for use with electron accelerators Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. Radiographic Proposal begins : 2022-08-10	Proposal
PNW 62B-1321 ED1:	Artificial Intelligence enabled Medical Devices ? computer assisted analysis software for pulmonary images - algorithm performance test methods Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Medical equipment. Diagnostic Proposal begins : 2023-06-02	Proposal
PNW 62B-1303 ED1:	Methods for spectral imaging performance evaluation of computed tomography Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| Medical equipment. Diagnostic Proposal begins : 2022-10-14	Proposal
PNW 62A-1539 ED1:	Packaging for non-sterile medical devices -- Requirements for packaging systems Categories: Information management \| Standardization. General rules Proposal begins : 2024-01-05	Proposal
BS EN IEC 63524 ED1	Artificial Intelligence enabled Medical Devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods Categories: Medical equipment. Diagnostic Public comment begins : 2024-11-13	Public comment
BS EN IEC 63483 ED1	BS EN 63483 ED1 Methods for spectral imaging performance evaluation of computed tomography Categories: Medical equipment. Radiographic Public comment begins : 2024-09-19	Public comment
BS EN 62563-3 Ed.1.0	Medical electrical equipment - Medical image display systems. Part 3: Evaluation methods for colour displays Categories: Medical equipment. Diagnostic \| Electronic display devices Public comment begins : 2023-07-12	Public comment
BS EN 61223-3-5	Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment Categories: Medical equipment. Radiographic Public comment begins : 2019-06-07	Public comment
BS EN 60601-2-37:2024	Medical electrical equipment. Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Categories: Medical equipment. Diagnostic \| Electroacoustics Approval begins : 2024-07-08	Approval
62B/1321/NP	Artificial Intelligence enabled Medical Devices — computer assisted analysis software for pulmonary images - algorithm performance test methods Categories: Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. Diagnostic \| ICT \| Information technology \| IT applications. Health care technology Proposal begins : 2023-07-13	Proposal

Published (45)

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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 60522-2:2020	Medical electrical equipment. Diagnostic X-rays. Guidance and rationale on quality equivalent filtration and permanent filtration Categories: Medical equipment. Radiographic Published standard begins : 2020-11-02	Published standard
BS EN IEC 63077:2019	Good refurbishment practices for medical imaging equipment Categories: Medical equipment. Diagnostic Published standard begins : 2020-01-03	Published standard
BS EN IEC 62563-2:2021	Medical electrical equipment. Medical image display systems. Acceptance and constancy tests for medical image displays Categories: Medical equipment. Diagnostic \| Electronic display devices Published standard begins : 2022-03-10	Published standard
BS EN IEC 62464-1:2019	Magnetic resonance equipment for medical imaging. Determination of essential image quality parameters Categories: Medical equipment. Radiographic Published standard begins : 2019-03-05	Published standard
BS EN IEC 62220-2-1:2023	Medical electrical equipment. Characteristics of digital X-ray imaging devices.-COPY. Part 2-1: Determination of dual-energy subtraction efficiency. Detectors used for dual-energy radiographic imaging-COPY Categories: Medical equipment. Radiographic Published standard begins : 2023-08-15	Published standard
BS EN IEC 61223-3-8:2024	Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of X-ray equipment for radiography and radioscopy Categories: Medical equipment. Radiographic Published standard begins : 2024-05-20	Published standard
BS EN IEC 61223-3-7:2021	Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography Categories: Medical equipment. Radiographic Published standard begins : 2022-02-07	Published standard
BS EN IEC 61223-3-6:2020	Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation Categories: Medical equipment. Radiographic Published standard begins : 2020-04-06	Published standard
BS EN IEC 60806:2022	Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis Categories: Medical equipment. Radiographic Published standard begins : 2023-01-20	Published standard
BS EN IEC 60601-2-54:2024	Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Categories: Medical equipment. Radiographic Published standard begins : 2024-09-26	Published standard

Withdrawn (46)

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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/PAS 63077:2016	Good refurbishment practices for medical imaging equipment Categories: Medical equipment. Diagnostic Withdrawn begins : 2020-01-03	Withdrawn
BS IEC 61223-2-9:1999	Evaluation and routine testing in medical imaging departments. Constancy tests. Equipment for indirect radioscopy and indirect radiography Categories: Medical equipment. Radiographic Withdrawn begins : 2011-02-04	Withdrawn
BS IEC 61223-2-7:1999	Evaluation and routine testing in medical imaging departments. Constancy tests. Equipment for intra-oral dental radiography excluding dental panoramic equipment Categories: Medical equipment. Radiographic \| Dental equipment \| Radiographic films Withdrawn begins : 2011-02-04	Withdrawn
BS IEC 61223-2-11:1999	Evaluation and routine testing in medical imaging departments. Constancy tests. Equipment for general direct radiography Categories: Medical equipment. Radiographic Withdrawn begins : 2011-02-04	Withdrawn
BS IEC 61223-2-10:2000	Evaluation and routine testing in medical imaging departments. Constancy tests. X-ray equipment for mammography Categories: Medical equipment. Radiographic Withdrawn begins : 2011-02-04	Withdrawn
BS EN IEC 62985:2019	Methods for calculating size specific dose estimates (SSDE) on computed tomography Categories: Medical equipment. Radiographic Withdrawn begins : 2022-09-01	Withdrawn
BS EN IEC 61223-3-5:2019	Evaluation and routine testing in medical imaging departments. Acceptance tests and and constancy tests. Imaging performance of computed tomography X-ray equipment Categories: Medical equipment. Radiographic Withdrawn begins : 2022-08-15	Withdrawn
BS EN IEC 60336:2021	Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Focal spot dimensions and related characteristics Categories: Medical equipment. Radiographic Withdrawn begins : 2022-09-01	Withdrawn
BS EN 62563-1:2010+A1:2016	Medical electrical equipment. Medical image display systems. Evaluation methods Categories: Medical equipment. Diagnostic Withdrawn begins : 2021-09-01	Withdrawn
BS EN 62563-1:2010	Medical electrical equipment. Medical image display systems. Evaluation methods Categories: Medical equipment. Diagnostic Withdrawn begins : 2019-05-22	Withdrawn

Standards Development

CH/62/2 - Medical imaging equipment, software, and systems

Committee standards activity