British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/62 is responsible for UK input into IEC/SC 62A, the preparation of British Standards and other publications concerning the common aspects of the design, development, installation and application of medical equipment, software, and systems.

Committee standards activity

In Progress (24)

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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 TS 62A-1556 ED1:	Medical devices - Part 2: Guidance on the application of usability engineering to medical devices Categories: Information management \| Standardization. General rules Proposal begins : 2024-01-17	Proposal
PNW TS 62A-1491 ED1:	Health software and health IT systems safety, effectiveness and security - Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls Categories: Information management \| Standardization. General rules \| ICT \| Information technology \| Information technology applications \| IT applications. Health care technology Proposal begins : 2022-10-14	Proposal
PNW PAS 62-531 ED1:	Data management and data quality assessment for medical devices Categories: Information management \| Standardization. General rules Proposal begins : 2024-10-15	Proposal
PNW PAS 106-628 ED1:	Methods for validation of SAR measurement systems for hand-held and body-mounted wireless communication devices (Frequency range of 4 MHz to 10 GHz) Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General \| IT applications. Health care technology Proposal begins : 2023-11-29	Proposal
PD IEC/TS 81001-2-2 ED1	Health software and health IT systems safety, effectiveness and security-. Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls Categories: Unclassified documents Public comment begins :	Public comment
PD IEC/TS 81001-2-1 ED1	Health software and health IT systems safety, effectiveness and security-. Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security Categories: Unclassified documents Approval begins :	Approval
PD IEC/TS 62366-2 ED1	Medical devices. Part 2: Guidance on the application of usability engineering to medical devices Categories: Unclassified documents Public comment begins :	Public comment
PD IEC/TR 80001-2-8 Ed.2.0	Application of risk management for IT-networks incorporating medical devices. - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 Categories: Unclassified documents Public comment begins :	Public comment
PD IEC/TR 80001-2-2 Ed.2.0	Application of risk management for IT-networks incorporating medical devices. - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls Categories: Unclassified documents Public comment begins :	Public comment
PD IEC/TR 60601-4-9 ED1	Medical electrical equipment. Part 4-9: Guidance and interpretation - essential performance fault safety Categories: Unclassified documents Public comment begins :	Public comment

Published (38)

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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 ISO/TR 80002-2:2017	Medical device software. Validation of software for medical device quality systems Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2017-10-18	Published standard
PD ISO/TR 80001-2-7:2015	Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2015-03-27	Published standard
PD ISO/TR 80001-2-6:2014	Application of risk management for IT-networks incorporating medical device. Application guidance. Guidance for responsibility agreements Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2014-11-28	Published standard
PD IEC/TR 80002-3:2014	Medical device software. Process reference model of medical device software life cycle processes (IEC 62304) Categories: Medical equipment. General Published standard begins : 2014-07-11	Published standard
PD IEC/TR 80002-1:2009	Medical device software. Guidance on the application of ISO 14971 to medical device software Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2010-05-14	Published standard
PD IEC/TR 80001-2-9:2017	Application of risk management for it-networks incorporating medical devices. Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2017-02-07	Published standard
PD IEC/TR 80001-2-8:2016	Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 Categories: Medical equipment. General Published standard begins : 2016-05-31	Published standard
PD IEC/TR 80001-2-5:2014	Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on distributed alarm systems Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2015-01-05	Published standard
PD IEC/TR 80001-2-4:2012	Application of risk management for IT-networks incorporating medical devices. Application guidance. General implementation guidance for healthcare delivery organizations Categories: IT applications. Health care technology \| Medical equipment. General Published standard begins : 2013-01-29	Published standard
PD IEC/TR 80001-2-3:2012	Application of risk management for IT-networks incorporating medical devices. Guidance for wireless networks Categories: Medical equipment. General \| IT applications. Health care technology Published standard begins : 2012-10-26	Published standard

Withdrawn (32)

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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 60601-4-3:2015	Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements Categories: Medical equipment. General Withdrawn begins : 2019-01-04	Withdrawn
PD IEC/TR 60601-4-2:2016	Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems Categories: Medical equipment. General \| Immunity Withdrawn begins : 2024-04-05	Withdrawn
PD IEC TR 62296:2003	Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Categories: Medical equipment. General Withdrawn begins : 2009-07-02	Withdrawn
PD IEC TR 60878:2022	Graphical symbols for electrical equipment in medical practice Categories: Graphical symbols. Specific equipment \| Graphical symbols for use on electrical and electronics engineering drawings, diagrams, charts and in relevant technical product documentation \| Medical equipment.Therapy Withdrawn begins : 2023-04-05	Withdrawn
BS IEC 82304-1:2016	Health software. General requirements for product safety Categories: IT applications. Health care technology Withdrawn begins : 2017-12-11	Withdrawn
BS EN 80001-1:2011	Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities Categories: Medical equipment. General \| IT applications. Health care technology Withdrawn begins : 2021-11-01	Withdrawn
BS EN 62366:2008+A1:2015	Medical devices. Application of usability engineering to medical devices Categories: Medical equipment. General Withdrawn begins : 2018-07-17	Withdrawn
BS EN 62366:2008	Medical devices. Application of usability engineering to medical devices Categories: Medical equipment. General Withdrawn begins : 2021-03-12	Withdrawn
BS EN 62366-1:2015	Medical devices. Application of usability engineering to medical devices Categories: Medical equipment. General Withdrawn begins : 2016-01-14	Withdrawn
BS EN 62353:2008	Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment Categories: Medical equipment. General Withdrawn begins : 2018-07-17	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

AXREM
BAREMA
BSI Assurance UK
BSI Notified Body
BSI Standards Development Manager
Closed Loop Medicine
Committee Manager
Compliance Solutions
Deputy Chair
Dorset County NHS Foundation Trust
E M C Test Laboratories Association
Elekta Limited
EMERGO by UL
Fannin UK
G A M B I C A Association Limited
Heriot-Watt University
Human Factors Centre Ltd
Hypervision Surgical
I P E M - Institute of Physics and Engineering in Medicine
Intertek Group PLC
Kinneir Dufort
LFH Regulatory Limited
M H R A - Medicines and Healthcare products Regulatory Agency
NHS England
Quanta Dialysis Technologies
Red Medtech Ltd
Renishaw plc
Roche Diagnostics
Shandon Diagnostics
Stryker UK Ltd
UL Solutions
Ulster University
University of Oxford
University of Plymouth

Liaisons with other committees

Individual Capacity - Expert in Medical Device Software Development Pra
Individual Capacity - IEC 60601 Series
Individual Capacity - IEC 62366, 62304, 80002-1 & 80002-2
Individual Capacity - Testing Expert
Individual Capacity – Expert in IEC 60601-1 Series
Individual Capacity – Notified Body NSF
Liaison - AMT/-
Liaison - CH/198
Liaison - CH/210/4
Liaison - CH/62/4
Liaison - IST/35

BSI roles

Committee Chair

CH/62/1 - Common aspects of medical equipment, software, and systems

Committee standards activity