British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/62 is responsible for UK input into IEC/SC 62C, the preparation pf British standards and other publications to support safety and performance of medical equipment, software, and systems using ionising radiation for the treatment of disease. This includes: - associated equipment and software used in planning, delivering, and monitoring such treatments - instruments measuring ionising radiation used in the diagnosis and treatment of disease as well as radiation conditions for testing them - and nuclear medicine equipment used for imaging the distribution of radioactive substances within the human body for both diagnostic purposes and radionuclide therapies.

Committee standards activity

In Progress (13)

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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.
BS EN IEC 63465 Ed.1.0	BS EN 63465 Ed.1.0 Calibration and quality control in the use of radionuclide calibrators Categories: Medical equipment. Radiographic Public comment begins : 2023-08-01	Public comment
BS EN IEC 63322 Ed.1.0	Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources Categories: Medical equipment. General \| Medical equipment. Radiographic \| Medical equipment. Other Public comment begins : 2021-01-14	Public comment
BS EN IEC 63321 Ed.1.0	Medical Electrical Equipment - Functional Performance Characteristics for X-ray-based image-guided radiotherapy equipment Categories: Medical equipment. Radiographic Public comment begins : 2024-11-18	Public comment
BS EN IEC 62083	Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems Categories: Medical equipment.Therapy Public comment begins : 2019-02-07	Public comment
BS EN IEC 61675-2	BS EN 61675-2 Radionuclide imaging devices - Characteristics and test conditions. Part 2: Gamma cameras for planar, wholebody, and SPECT imaging Categories: Medical equipment. Radiographic Public comment begins : 2023-05-24	Public comment
BS EN IEC 61267 Ed.3.0	BS EN 61267 Ed.3.0 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics Categories: Medical equipment. Radiographic Public comment begins : 2023-08-17	Public comment
BS EN IEC 61217	Radiotherapy equipment - Coordinates, movements and scales Categories: Medical equipment. Radiographic \| Radiation protection Public comment begins : 2020-08-11	Public comment
BS EN IEC 60601-2-92 ED.1	BS EN 60601-2-92 ED.1 Medical electrical equipment. for use with electron accelerators for use with electron accelerators Categories: Medical equipment.Therapy Public comment begins : 2025-03-20	Public comment
BS EN 60601-2-93 Ed. 1.0	BS EN 60601-2-93 Ed. 1.0. Medical electrical equipment. Part 2-93: Particular requirements for the basic safety and essential performance of neutron capture therapy equipment Categories: Medical equipment \| Medical equipment. General Public comment begins : 2024-11-18	Public comment
BS EN 60601-2-68 Amd.1	Amendment 1 - Electrical medical equipment. - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment Categories: Medical equipment.Therapy Approval begins : 2024-11-15	Approval

Published (31)

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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 61948-3:2018	Nuclear medicine instrumentation. Routine tests. Positron emission tomographs Categories: Medical equipment. Radiographic Published standard begins : 2018-02-14	Published standard
PD IEC/TR 61948-1:2016	Nuclear medicine instrumentation. Routine tests. Gamma radiation counting system Categories: Medical equipment. Radiographic Published standard begins : 2016-04-13	Published standard
PD IEC/TR 60977:2008	Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics Categories: Medical equipment. Radiographic \| Radiation protection Published standard begins : 2008-08-28	Published standard
PD IEC TR 63183:2019	Guidance on error and warning messages for software used in radiotherapy Categories: Medical equipment.Therapy Published standard begins : 2020-01-03	Published standard
PD IEC TR 62926:2019	Medical electrical system. Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy Categories: Medical equipment. Radiographic Published standard begins : 2019-06-07	Published standard
PD IEC TR 61948-4:2019	Nuclear medicine instrumentation. Routine tests. Radionuclide calibrators Categories: Medical equipment. Radiographic Published standard begins : 2019-03-28	Published standard
PD IEC TR 61948-2:2019	Nuclear medicine instrumentation. Routine tests. Scintillation cameras and single photon emission computed tomography imaging Categories: Medical equipment. Radiographic Published standard begins : 2019-08-29	Published standard
BS EN IEC 63073-1:2020	Dedicated radionuclide imaging devices. Characteristics and test conditions. Cardiac SPECT Categories: Medical equipment. Radiographic Published standard begins : 2020-12-08	Published standard
BS EN IEC 62667:2018	Medical electrical equipment. Medical light ion beam equipment. Performance characteristics Categories: Medical equipment.Therapy Published standard begins : 2018-04-24	Published standard
BS EN IEC 61675-1:2022	Radionuclide imaging devices. Characteristics and test conditions. Positron emission tomographs Categories: Medical equipment. Radiographic \| IT applications. Health care technology Published standard begins : 2022-05-12	Published standard

Withdrawn (19)

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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 61948-3:2005	Nuclear medicine instrumentation. Routine tests. Positron emission tomographs Categories: Medical equipment. Radiographic Withdrawn begins : 2018-02-14	Withdrawn
BS EN IEC 61676:2023	Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology Categories: Medical equipment. Radiographic \| Medical equipment. Diagnostic Withdrawn begins : 2024-02-19	Withdrawn
BS EN 61676:2002+A1:2009	Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology Categories: Medical equipment. Radiographic \| Medical equipment. Diagnostic Withdrawn begins : 2023-05-26	Withdrawn
BS EN 61676:2002	Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology Categories: Medical equipment. Radiographic \| Medical equipment. Diagnostic Withdrawn begins : 2009-10-08	Withdrawn
BS EN 61675-2:1998, IEC 61675-2:1998	Radionuclide imaging devices. Characteristics and test conditions. Single photon emission computed tomographs Categories: Medical equipment. Radiographic \| IT applications. Health care technology Withdrawn begins : 2018-10-08	Withdrawn
BS EN 61675-1:2014	Radionuclide imaging devices. Characteristics and test conditions. Positron emission tomographs Categories: Medical equipment. Radiographic \| IT applications. Health care technology Withdrawn begins : 2022-05-12	Withdrawn
BS EN 61675-1:1998+A1:2008, IEC 61675-1:1998	Radionuclide imaging devices. Characteristics and test conditions. Positron emission tomographs Categories: Medical equipment. Radiographic \| IT applications. Health care technology Withdrawn begins : 2014-07-11	Withdrawn
BS EN 61674:2013	Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging Categories: Medical equipment. Radiographic \| Measurement. Radiation Withdrawn begins : 2024-09-03	Withdrawn
BS EN 61217:1996+A2:2008, IEC 61217:1996	Radiotherapy equipment. Coordinates, movements and scales Categories: Medical equipment. Radiographic \| Radiation protection Withdrawn begins : 2015-01-06	Withdrawn
BS EN 60789:2005	Medical electrical equipment. Characteristics and test conditions of radionuclide imaging devices. Anger type gamma cameras Categories: Medical equipment. Radiographic Withdrawn begins : 2018-10-08	Withdrawn

Standards Development

CH/62/3 - Equipment for radiotherapy, nuclear medicine and radiation dosimetry

Committee standards activity