British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee is responsible for UK input into CEN/TC205 standardization in the field of non-active medical device.

Committee standards activity

In Progress (7)

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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.
Draft Decision 16-2019 - Revision of EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation Categories: Information management \| Standardization. General rules \| Measurement and Science \| Metrology and measurement \| Testing \| Healthcare \| Medical equipment \| Medical equipment. General \| Medical equipment. Other Proposal begins : 2019-10-16	Proposal
Draft Dec 9/2021 - AdoptNewWI - EN ISO 24072,	Aerosol bacterial retention test method for air-inlet on administration devices Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Medical equipment. General Proposal begins : 2021-08-03	Proposal
Draft Dec 7-2023 - AdoptionPWI for RIPD	Respiratory infection prevention devices for self- and third-party protection - Requirements and test methods Categories: Information management \| Standardization. General rules \| Healthcare \| Medical equipment \| Anaesthetic, respiratory and reanimation equipment Proposal begins : 2023-03-01	Proposal
BS EN 14683:2025	Medical face masks - Requirements and test methods Categories: Hospital equipment Approval begins :	Approval
BS EN 13795-2:2025	Surgical clothing and drapes - Requirements and test methods. - Part 2: Clean air suits Categories: Hospital equipment Approval begins :	Approval
BS EN 13795-1:2025	Surgical clothing and drapes - Requirements and test methods. - Part 1: Surgical drapes and gowns Categories: Hospital equipment Approval begins :	Approval
BS 7505	BS 7505: 2025, Elastic properties of flat, non-adhesive, extensible fabric bandages – Specification Categories: Wound dressings and compresses Public comment begins : 2024-11-29	Public comment

Published (11)

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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 EN ISO 8536-5:2013	Infusion equipment for medical use. Burette infusion sets for single use, gravity feed Categories: Transfusion, infusion and injection equipment Published standard begins : 2013-02-22	Published standard
BS EN ISO 22612:2005	Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration Categories: Hospital equipment \| Protective clothing Published standard begins : 2005-03-24	Published standard
BS EN ISO 22610:2006	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Test method to determine the resistance to wet bacterial penetration Categories: Hospital equipment Published standard begins : 2007-01-22	Published standard
BS EN 17854:2024	Antimicrobial wound dressings. Requirements and test method Categories: Wound dressings and compresses Published standard begins : 2024-04-04	Published standard
BS EN 1644-2:2000	Test methods for nonwoven compresses for medical use. Finished compresses Categories: Wound dressings and compresses Published standard begins : 2000-12-18	Published standard
BS EN 14079:2003	Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze Categories: Surgical instruments and materials Published standard begins : 2003-05-09	Published standard
BS EN 13795-2:2019	Surgical clothing and drapes. Requirements and test methods. Clean air suits Categories: Hospital equipment Published standard begins : 2019-04-12	Published standard
BS EN 13795-1:2019	Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns Categories: Hospital equipment Published standard begins : 2019-04-12	Published standard
BS EN 13726:2023	Test methods for wound dressings. Aspects of absorption, moisture vapour transmission, waterproofness and extensibility Categories: Wound dressings and compresses Published standard begins : 2023-09-21	Published standard
BS 7563:1999	Specification for non-prescriptive graduated support hosiery Categories: Pharmaceutics \| Clothes Published standard begins : 1999-04-01	Published standard

Withdrawn (24)

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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.
DD ENV 12719:2001	Medical thrombosis prophylaxis hosiery Categories: Wound dressings and compresses Withdrawn begins : 2011-04-13	Withdrawn
DD ENV 12718:2001	Medical compression hosiery Categories: Wound dressings and compresses Withdrawn begins : 2011-04-13	Withdrawn
BS EN ISO 8536-5:2011	Infusion equipment for medical use. Burette infusion sets for single use, gravity feed Categories: Transfusion, infusion and injection equipment Withdrawn begins : 2013-02-22	Withdrawn
BS EN ISO 81060-2:2014	Non-invasive sphygmomanometers. Clinical investigation of automated measurement type Categories: Anaesthetic, respiratory and reanimation equipment \| Medical equipment. Diagnostic Withdrawn begins : 2019-12-09	Withdrawn
BS EN ISO 80601-2-56:2012	Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Categories: Medical equipment. Diagnostic Withdrawn begins : 2013-01-02	Withdrawn
BS EN ISO 10555-6:2017	Intravascular catheters. Sterile and single-use catheters. Subcutaneous implanted ports Categories: Syringes, needles and catheters Withdrawn begins : 2019-11-05	Withdrawn
BS EN 14683:2019	Medical face masks. Requirements and test methods Categories: Hospital equipment Withdrawn begins : 2019-08-22	Withdrawn
BS EN 14683:2014	Medical face masks. Requirements and test methods Categories: Hospital equipment Withdrawn begins : 2019-03-27	Withdrawn
BS EN 14683:2005	Surgical masks. Requirements and test methods Categories: Hospital equipment Withdrawn begins : 2014-04-03	Withdrawn
BS EN 13795:2011+A1:2013	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels Categories: Hospital equipment Withdrawn begins : 2020-02-05	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

British Healthcare Trades Association
BSI Standards Development Manager
Carolon
Committee Manager
ConvaTec Ltd
Heriot-Watt University
medi UK
Micramed Ltd
Molnlycke Health Care
Re-Usable Healthcare Textile Association
Sallis Healthcare Ltd
Solventum
Surgical Dressings Manufacturers Association
Surgical Material Testing Laboratory
Textile Services Association Ltd
United Medical Innovations Ltd

Liaisons with other committees

Chair - CH/205/10
Co Opted
Individual Capacity - Baxter
Individual Capacity - Catheter and Connector Expert
Liaison - CH/157
Liaison - CH/205/3
Liaison - PH/4
Liaison - TCI/24
Secretary – CH/212

BSI roles

Committee Chair

CH/205 - Non-active medical devices

Committee standards activity