British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of CH/210, is responsible for UK input into CEN/CLC JTC 3, ISO/TC 210/WG 2 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)

Show entries

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 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 20417	Medical devices — Information to be supplied by the manufacturer Categories: Medical equipment. General Comment resolution begins : 2025-12-03	Comment resolution
BS EN ISO 15223-1:2021+A1:2025 CD-ROM	Medical devices. Symbols to be used with information to be supplied by the manufacturer Categories: Graphical symbols. Specific equipment \| Medical equipment. General Approval begins : 2025-04-11	Approval

Published (8)

Show entries

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: Medical equipment. General \| Health care technology 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)

Show entries

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: Medical equipment. General \| Medical equipment.Therapy \| Graphical symbols. Specific equipment \| Graphical symbols for use on electrical and electronics engineering drawings, diagrams, charts and in relevant technical product documentation 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
Medtronic
Quality Management Systems for Medical Devices
Regulatory Insights Ltd
RQM+
Teva Pharmaceutical Industries
University of Nottingham
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 – Expertise in QMS/MDSAP, design controls
Liaison - CH/173

BSI roles

Committee Chair

Standards Development

CH/210/3 - General information for medical devices

Committee standards activity