British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee, is responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices.

Committee standards activity

In Progress (35)

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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 37137-2	Biological evaluation for absorbable medical devices. Part 2: Evaluation and testing of medical devices for soft tissue repair Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 29741	Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) Categories: Unclassified documents Drafting begins : 2018-06-01	Drafting
PD ISO/TS 26420	Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1 Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 26177	Risk estimation for biological evaluation Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 25364-4	Analytical chemistry matters associated with ISO 10993-18. Part 5: Guidelines for the implementation of a community-based early warning system for volcanic eruptions Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 25364-3	Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for performing Non-Targeted Analysis for organic medical device extractables and leachables via Non-Target Analysis (NTA) Categories: Unclassified documents Drafting begins : 2025-05-13	Drafting
PD ISO/TS 25364-2	Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) Categories: Unclassified documents Drafting begins : 2025-05-22	Drafting
PD ISO/TS 25364-1	Analytical chemistry matters associated with 10993-18 — Part 1: Identification of organic medical device extractables and leachables via Non-Target Analysis (NTA) Categories: Unclassified documents Comment resolution begins : 2025-09-04	Comment resolution
PD ISO/TS 24830	Application of in-silico/read-across approaches for identifying a medical device constituent analogue Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 21726	Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents Categories: Unclassified documents Drafting begins : 2026-05-19	Drafting

Published (42)

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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 37137-1:2021	Biological evaluation of absorbable medical devices. General requirements Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2021-03-15	Published standard
PD ISO/TS 21726:2019	Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents Categories: Medical devices. Biological evaluation Published standard begins : 2019-02-05	Published standard
PD ISO/TS 11796:2023	Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices Categories: Medical devices. Biological evaluation Published standard begins : 2023-08-02	Published standard
PD ISO/TS 10993-19:2020	Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials Categories: Medical devices. Biological evaluation Published standard begins : 2020-03-16	Published standard
PD ISO/TR 37137:2014	Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2014-06-06	Published standard
PD ISO/TR 22442-4:2010	Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes Categories: Medical devices. Biological evaluation Published standard begins : 2011-02-16	Published standard
PD ISO/TR 21582:2021	Pyrogenicity. Principles and methods for pyrogen testing of medical devices Categories: Medical devices. Biological evaluation Published standard begins : 2021-07-28	Published standard
PD ISO/TR 15499:2016	Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process Categories: Medical devices. Biological evaluation Published standard begins : 2017-01-04	Published standard
PD ISO/TR 10993-55:2023	Biological evaluation of medical devices. Interlaboratory study on cytotoxicity Categories: Medical devices. Biological evaluation Published standard begins : 2023-02-20	Published standard
PD ISO/TR 10993-33:2015	Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3 Categories: Medical devices. Biological evaluation Published standard begins : 2015-03-24	Published standard

Withdrawn (60)

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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 15499:2012	Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process Categories: Medical devices. Biological evaluation Withdrawn begins : 2017-01-04	Withdrawn
DD ISO/TS 10993-19:2006	Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials Categories: Medical devices. Biological evaluation Withdrawn begins : 2020-03-16	Withdrawn
BS EN ISO 9363-1:1999	Optics and optical instruments. Contact lenses. Determination of cytotoxicity of contact lens material. Agar overlay test and growth inhibition test Categories: Medical equipment. Ophthalmic Withdrawn begins : 2023-09-22	Withdrawn
BS EN ISO 22442-2:2007	Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling Categories: Medical devices. Biological evaluation Withdrawn begins : 2015-12-08	Withdrawn
BS EN ISO 22442-1:2007	Medical devices utilizing animal tissues and their derivatives. Application of risk management Categories: Medical devices. Biological evaluation Withdrawn begins : 2015-11-27	Withdrawn
BS EN ISO 14155:2020+A11:2024	Clinical investigation of medical devices for human subjects. Good clinical practice Categories: Medical devices. Biological evaluation Withdrawn begins : 2026-04-22	Withdrawn
BS EN ISO 14155:2020	Clinical investigation of medical devices for human subjects. Good clinical practice Categories: Medical devices. Biological evaluation Withdrawn begins : 2020-08-19	Withdrawn
BS EN ISO 14155:2011	Clinical investigation of medical devices for human subjects. Good clinical practice Categories: Medical devices. Biological evaluation Withdrawn begins : 2011-09-16	Withdrawn
BS EN ISO 14155-2:2009	Clinical investigation of medical devices for human subjects. Clinical investigation plans Categories: Medical devices. Biological evaluation Withdrawn begins : 2011-02-22	Withdrawn
BS EN ISO 14155-2:2003	Clinical investigation of medical devices for human subjects. Clinical investigation plans Categories: Medical equipment. General \| Medical devices. Biological evaluation Withdrawn begins : 2010-01-15	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
Abbot Diabetes Care
Association of Contact Lens Manufacturers
B S I Testing Services
British Toxicology Society
BSI - Technical Specialist
BSI Clinical Regulatory Lead
BSI Standards Development Manager
Chorley Consulting
Committee Manager
ConvaTec Ltd
Deputy Chair
Element Materials Technology Ltd
GE HealthCare
Individual expertise - Biological Evaluation
M H R A - Medicines and Healthcare products Regulatory Agency
NC3Rs
RQM+
Steris
University of Manchester

Liaisons with other committees

Co Opted
Co Opted - Biocompatibility Expert
Co Opted - High Risk Devices
Individual Capacity - Animal Tissues & Biocompatibility
Individual Capacity - Applied researcher specialising in biomaterials, s
Individual Capacity - Biocompatibility
Individual Capacity - Biomedical Materials Scientist
Individual Capacity - Chemical Analysis
Individual Capacity - clinical and regulatory specialist
Individual Capacity - Human HealthToxicology
Individual Capacity - Microbiology
Individual Capacity - Perfusion Expert
Individual Capacity - Senior Business Development Manager
Individual Capacity - Smith & Nephew
Individual Capacity - Standard development/certification
Individual Capacity - Toxicology Expert
Individual capacity – Biological Safety and Animal Tissue Expert
Liaison - CH/210/4
UK Expert - ISO/TC 194/WG 19

BSI roles

Committee Chair

CH/194 - Biological evaluation of medical devices

Committee standards activity