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 (26)

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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 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/TR 37137-2	Biological evaluation of absorbable medical devices. Part 2: Standard guide for absorbable metals Categories: Implants for surgery, prosthetics and orthotics Approval begins :	Approval
ISO/NP TS 25364	Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18 Categories: Information management \| Standardization. General rules Proposal begins : 2024-07-14	Proposal
Draft Decision CEN/TC 206 003/2023	Medical devices utilizing human tissues and their derivatives -- Application of risk management Categories: Standardization. General rules \| Quality \| Healthcare \| Medical equipment \| Sterilization and disinfection \| Medical devices. Biological evaluation Proposal begins : 2023-08-04	Proposal
Draft Decision CEN/TC 206 002/2023	Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants Categories: Standardization. General rules \| Metrology and measurement \| Healthcare \| Sterilization and disinfection \| Medical devices. Biological evaluation Proposal begins : 2023-08-04	Proposal
draft Decision 001/2024 - NWIP -	EN ISO 14155/A11 Categories: Information management \| Standardization. General rules \| Healthcare \| Laboratory medicine \| Laboratory medicine. General Proposal begins : 2023-11-15	Proposal
BS ISO 10993-20	Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices Categories: Unclassified documents Drafting begins : 2024-07-31	Drafting
BS ENISO 10993-7	Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals Categories: Medical devices. Biological evaluation Drafting begins : 2017-02-27	Drafting
BS ENISO 10993-5	BS ENISO 10993-5 Biological evaluation of medical devices. Part 5: Tests for in vitro cytotoxicity Categories: Unclassified documents Drafting begins : 2014-04-23	Drafting
BS EN ISO 8250	Cleanliness of medical devices — Process design and test methods Categories: Unclassified documents Proposal begins :	Proposal

Published (41)

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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 (51)

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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 14155:2011	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
BS EN ISO 14155-1:2009	Clinical investigation of medical devices for human subjects. General requirements Categories: Medical devices. Biological evaluation Withdrawn begins : 2011-02-22	Withdrawn
BS EN ISO 14155-1:2003	Clinical investigation of medical devices for human subjects. General requirements Categories: Technical drawings \| Medical equipment. General \| Medical devices. Biological evaluation \| Document imaging applications 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
Association of Contact Lens Manufacturers
B S I Testing Services
British Dental Association
BSI Clinical Regulatory Lead
Chorley Consulting
Committee Manager
Element Materials Technology Ltd
GMED UK
Individual Expert - Consultant anaesthetist and Internal clinician for
L G C Group
M H R A - Medicines and Healthcare products Regulatory Agency
NC3Rs
Steris
U K Government

Liaisons with other committees

Chair - CH/210/4
Chair - GEL/86/2
Co Opted - Biocompatibility Expert
Co Opted - High Risk Devices
Individual Capacity - Animal Tissue Expert
Individual Capacity - Animal Tissues & Biocompatibility
Individual Capacity - Biocompatibility
Individual Capacity - Biomedical Materials Scientist
Individual Capacity - Chemical Analysis
Individual Capacity - Clinical Evaluation Expert
Individual Capacity - Human HealthToxicology
Individual Capacity - Materials Emission Specialist
Individual Capacity - Perfusion Expert
Individual Capacity - Product Risk Assessment
Individual Capacity - Quality Management Systems
Individual Capacity - Senior Business Development Manager
Individual Capacity - Standard development/certification
Individual Capacity - Toxicology Expert
Individual capacity – Biological Safety and Animal Tissue Expert
Liaison - ISO/TC 194/WG 19
UK Expert - ISO/TC 194/WG 19

BSI roles

Committee Chair

Standards Development

CH/194 - Biological evaluation of medical devices

Committee standards activity