British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/210, is responsible for UK input into CEN/CLC JTC 3 and ISO/TC 210/WG 3 and the preparation, revision and amendment of British Standards in the field of general terminology and symbols for medical devices.

Committee standards activity

In Progress (4)

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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 ISO 15223-2	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 15223-2	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation Categories: Unclassified documents Drafting begins : 2025-06-13	Drafting
BS EN ISO 23421	Medical devices — Terminology — Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices Categories: Unclassified documents Proposal begins :	Proposal
BS EN ISO 15223-1:2021/Amd 1	Medical devices — Symbols to be used with information to be supplied by the manufacturer —. Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific Categories: Graphical symbols. Specific equipment \| Medical equipment. General Public comment begins : 2024-05-23	Public comment

Published (8)

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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 60788:2004	Medical electrical equipment. Glossary of defined terms Categories: Health care technology \| Medical equipment. Radiographic Published standard begins : 2004-02-27	Published standard
PD CEN/TR 15133:2005	Nomenclature. Collective terms and codes for groups of medical devices Categories: Health care technology \| Medical equipment. General Published standard begins : 2005-12-09	Published standard
BS ISO 15223-2:2010	Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation Categories: Graphical symbols. Specific equipment \| Medical equipment. General Published standard begins : 2010-06-07	Published standard
BS EN ISO 15225:2000	Nomenclature. Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Categories: Health care technology \| Information technology. \| Medical equipment. General \| IT applications. Health care technology Published standard begins : 2004-04-01	Published standard
BS EN ISO 15223-1:2021	Medical devices. Symbols to be used with information to be supplied by the manufacturer. General requirements Categories: Graphical symbols. Specific equipment \| Medical equipment. General Published standard begins : 2021-09-29	Published standard
BS EN 15986:2011	Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates Categories: Graphical symbols. Specific equipment \| Medical equipment. General \| Pharmaceutics. General Published standard begins : 2011-03-15	Published standard
AMD 15844	BSENISO15225 : 2000 AMD2 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Categories: Health care technology \| Information technology. \| Medical equipment. General \| IT applications. Industry Published standard begins : 2005-12-15	Published standard
AMD 10801	BS EN 980-A1 Graphical symbols for use in the labelling of medical devices Categories: Graphical symbols. Specific equipment \| Medical equipment. General Published standard begins : 2000-03-14	Published standard

Withdrawn (18)

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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/TS 19218-2:2012	Medical devices. Hierarchical coding structure for adverse events. Evaluation codes Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2024-07-04	Withdrawn
PD IEC/TR 60878:2015	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 : 2022-11-14	Withdrawn
PD IEC/TR 60878:2003	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. General \| Medical equipment.Therapy Withdrawn begins : 2015-10-06	Withdrawn
PD CR 14230:2001	Global medical device nomenclature for the purpose of regulatory data exchange Categories: Health care technology \| Medical equipment. General Withdrawn begins : 2012-06-18	Withdrawn
DD ISO/TS 19218:2005	Medical devices. Coding structure for adverse event type and cause Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2012-05-28	Withdrawn
DD ISO/TS 19218-1:2011+A1:2013	Medical devices. Hierarchical coding structure for adverse events. Event-type codes Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2013-05-08	Withdrawn
DD ISO/TS 19218-1:2011	Medical devices. Hierarchical coding structure for adverse events. Event-type codes Categories: Quality management and quality assurance \| Medical equipment. General Withdrawn begins : 2013-04-04	Withdrawn
BS EN ISO 15225:2016	Medical devices. Quality management. Medical device nomenclature data structure Categories: Health care technology \| Information technology. \| Medical equipment. General \| IT applications. Health care technology Withdrawn begins : 2019-07-30	Withdrawn
BS EN ISO 15225:2010	Medical devices. Quality management. Medical device nomenclature data structure Categories: Health care technology \| Information technology. \| Medical equipment. General \| IT applications. Health care technology Withdrawn begins : 2016-04-12	Withdrawn
BS EN ISO 15225:2000	Nomenclature. Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Categories: IT applications. Health care technology \| Health care technology \| Information technology. \| Medical equipment. General Withdrawn begins : 2004-04-01	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
B S S - British Standards Society
Baby Products Industry Association (BPIA)
BAREMA
Chartered Quality Institute
Committee Manager
GMDN Agency Ltd
M H R A - Medicines and Healthcare products Regulatory Agency
Quality Management Systems for Medical Devices
Vernacare Limited

Liaisons with other committees

Individual Capacity - Expert in Polymer Materials
Individual Capacity - Expertise in Standardisation, Sterilization and
Individual Capacity - QARA Consultant
Individual Capacity - QMS auditing and human factors/usability testing
Individual capacity - quality assurance, regulatory affairs (EU/UK)
Individual Capacity – Expertise in QMS/MDSAP, design controls
Liaison - CH/173

BSI roles

Committee Chair

Standards Development

CH/210/3 - General terminology and symbols for Medical Devices

Committee standards activity