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Committee: CH/194 Biological evaluation of medical devices

Subject: Healthcare
Sector: Governance & Resilience
This committee is categorized in: Anaesthetic, respiratory & reanimation equipment, Dental materials, Dentistry, General, General, General, General, Hospital equipment, Laboratory medicine, Medical devices & biological evaluation , Medical equipment, Medical sciences & facilities; general, Ophthalmic , Optical equipment. You can view other committees in these categories by clicking on the category name.

Scope

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.

Sub-committee (1)
Standards in development (2)
Published standards (71)
Who is currently involved in this committee

Sub-committee (1)

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Committee Reference	Title
CH/194/-/1	Clinical Investigation of medical devices for human subjects

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Standards in development (2)

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Standard Title	Status
BS EN ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity	Public Comment
BS ISO 10993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation	Idea

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Published standards (71)

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Standard reference	Name	Status
BS EN 30993-4:1994	Biological evaluation of medical devices - Selection of tests for interactions with blood	Withdrawn
BS EN 30993-3:1994	Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity	Withdrawn
BS EN 30993-5:1994	Biological evaluation of medical devices - Tests for cytotoxicity, in vitro methods	Withdrawn
BS EN 30993-1:1994	Biological evaluation of medical devices - Guidance on selection of tests	Withdrawn
BS EN 30993-6:1995	Biological evaluation of medical devices - Tests for local effects after implantation	Withdrawn
BS EN ISO 10993-7:1996	Biological evaluation of medical devices - Ethylene oxide sterilization residuals	Withdrawn
BS EN ISO 10993-11:1996	Biological evaluation of medical devices - Tests for systemic toxicity	Withdrawn
BS EN ISO 10993-10:1996	Biological evaluation of medical devices - Tests for irritation and sensitization	Withdrawn
BS EN ISO 10993-12:1997	Biological evaluation of medical devices - Sample preparation and reference materials	Withdrawn
BS EN ISO 10993-4:2002	Biological evaluation of medical devices - Selection of tests for interactions with blood	Withdrawn
BS EN ISO 10993-10:2002	Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity	Withdrawn
BS EN ISO 10993-3:2003	Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity	Withdrawn
BS EN ISO 10993-12:2004	Biological evaluation of medical devices - Sample preparation and reference materials	Withdrawn
BS EN ISO 10993-18:2005	Biological evaluation of medical devices - Chemical characterization of materials	Withdrawn
BS EN ISO 10993-12:2007	Biological evaluation of medical devices - Sample preparation and reference materials	Withdrawn
DD ISO/TS 10993-19:2006	Biological evaluation of medical devices - Physico-chemical, morphological and topographical characterization of materials	Current
BS EN ISO 10993-2:2006	Biological evaluation of medical devices - Animal welfare requirements	Current
BS EN ISO 10993-11:2006	Biological evaluation of medical devices - Tests for systemic toxicity	Withdrawn
DD ISO/TS 10993-20:2006	Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices	Current
BS EN ISO 10993-13:2010	Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices	Current
BS EN ISO 10993-5:2009	Biological evaluation of medical devices - Tests for in vitro cytotoxicity	Current
BS EN ISO 10993-6:2007	Biological evaluation of medical devices - Tests for local effects after implantation	Withdrawn
BS EN ISO 10993-16:2010	Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables	Current
BS EN ISO 10993-6:2009	Biological evaluation of medical devices - Tests for local effects after implantation	Current
BS EN ISO 10993-4:2009	Biological evaluation of medical devices - Selection of tests for interactions with blood	Current
BS EN ISO 10993-3:2009	Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity	Current, Work in Hand
BS EN ISO 10993-18:2009	Biological evaluation of medical devices - Chemical characterization of materials	Current
BS EN ISO 10993-17:2009	Biological evaluation of medical devices - Establishment of allowable limits for leachable substances	Current
BS EN ISO 10993-16:2009	Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables	Withdrawn
BS EN ISO 10993-14:2009	Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics	Current
BS EN ISO 10993-13:2009	Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices	Withdrawn
BS EN ISO 10993-12:2009	Biological evaluation of medical devices - Sample preparation and reference materials	Withdrawn
BS EN ISO 10993-11:2009	Biological evaluation of medical devices - Tests for systemic toxicity	Current
BS EN ISO 10993-10:2009	Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity	Withdrawn
BS EN ISO 10993-12:2012	Biological evaluation of medical devices - Sample preparation and reference materials	Current
BS EN ISO 10993-15:2009	Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys	Current
BS EN ISO 10993-5:1999	Biological evaluation of medical devices - Tests for in vitro cytotoxicity	Withdrawn
BS EN ISO 10993-9:1999	Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products	Withdrawn
BS EN ISO 10993-8:2001	Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests	Withdrawn
BS EN ISO 10993-15:2001	Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys	Withdrawn
BS EN ISO 10993-1:2003	Biological evaluation of medical devices - Evaluation and testing	Withdrawn
BS EN ISO 10993-14:2001	Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics	Withdrawn
BS EN ISO 10993-17:2002	Biological evaluation of medical devices - Establishment of allowable limits for leachable substances	Withdrawn
BS EN ISO 10993-16:1997	Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables	Withdrawn
BS EN ISO 10993-1:1998	Biological evaluation of medical devices - Evaluation and testing	Withdrawn
BS EN ISO 10993-2:1998	Biological evaluation of medical devices - Animal welfare requirements	Withdrawn
BS EN ISO 10993-13:1999	Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices	Withdrawn
BS EN ISO 10993-7:2008	Biological evaluation of medical devices - Ethylene oxide sterilization residuals	Current
BS EN ISO 10993-1:2009	Biological evaluation of medical devices - Evaluation and testing	Withdrawn
BS EN ISO 10993-1:October 2009	Biological evaluation of medical devices - Evaluation and testing within a risk management process	Current
BS EN ISO 10993-9:December 2009	Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products	Current
BS EN ISO 10993-10:2010	Biological evaluation of medical devices - Tests for irritation and skin sensitization	Current
PD ISO/TR 15499:2012	Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process	Current
BS EN 540:1993	Clinical investigation of medical devices for human subjects	Withdrawn
BS EN ISO 14155-2:2003	Clinical investigation of medical devices for human subjects - Clinical investigation plans	Withdrawn
BS EN ISO 14155-1:2003	Clinical investigation of medical devices for human subjects - General requirements	Withdrawn
BS EN ISO 14155-1:2009	Clinical investigation of medical devices for human subjects - General requirements	Withdrawn
BS EN ISO 14155-2:2009	Clinical investigation of medical devices for human subjects - Clinical investigation plans	Withdrawn
BS EN ISO 7405:1997	Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials	Withdrawn
BS 5736-3:1981	Evaluation of medical devices for biological hazards - Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices	Withdrawn
BS 5736-4:1981	Evaluation of medical devices for biological hazards - Method of test for intracutaneous reactivity of extracts from medical devices	Withdrawn
BS 5736-5:1982	Evaluation of medical devices for biological hazards - Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices	Withdrawn
BS 5736-6:1983	Evaluation of medical devices for biological hazards - Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis	Withdrawn
BS 5736-7:1983	Evaluation of medical devices for biological hazards - Method of test for skin irritation of extracts from medical devices	Withdrawn
BS 5736-8:1984	Evaluation of medical devices for biological hazards - Method of test for skin irritation of solid medical devices	Withdrawn
BS 5736/2PRS:1986	Evaluation of medical devices for biological hazards - Positive control plastic reference standard for implantation	Withdrawn
BS 5736-9:1986	Evaluation of medical devices for biological hazards - Method of test for eye irritation	Withdrawn
BS EN ISO 10993-9:May 2009	Framework for identification and quantification of potential degradation products	Withdrawn
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	Current
BS 5828:1989	Methods for biological assessment of dental materials	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	Withdrawn

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Who is currently involved in this committee [ Get involved ]

Company name
A B H I - Association of British Healthcare Industries
Association of Contact Lens Manufacturers
British Dental Association
British Healthcare Trades Association
N I B S C - National Institute for Biological Standards and Control
Royal Society of Medicine
L G C Group
M H R A - Medicines and Healthcare products Regulatory Agency
National Blood Service
Co Opted - High Risk Devices

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