British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee, is responsible for UK input into ISO/TC 84 standardization in the field of catheters and syringes

Committee standards activity

In Progress (12)

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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 4452	Specification and demonstration of system reliability of single-use drug delivery systems Categories: Unclassified documents Drafting begins : 2024-09-26	Drafting
ISO/PWI 23217	Needle-based injection systems intended for self-administration by paediatric patients -- Guidance for design Categories: Standardization. General rules \| Healthcare \| Syringes, needles and catheters \| Medical equipment. Diagnostic Proposal begins : 2020-11-20	Proposal
BS ISO 18138	Procedures and devices for the removal, containment and disposal of scalpel blades from scalpel handles Categories: Unclassified documents Proposal begins :	Proposal
BS ISO 11194	Single-use syringes and needles — Requirements for ophthalmic use Categories: Unclassified documents Proposal begins :	Proposal
BS ENISO 7886-3	Sterile hypodermic syringes for single use. Part 3: Auto-disabled syringes for fixed-dose immunization Categories: Syringes, needles and catheters Public comment begins : 2016-11-28	Public comment
BS EN ISO 9626	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods Categories: Unclassified documents Drafting begins : 2024-12-24	Drafting
BS EN ISO 8537	Sterile single-use syringes, with or without needle, for insulin Categories: Unclassified documents Drafting begins : 2024-12-24	Drafting
BS EN ISO 7886-1	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use Categories: Unclassified documents Drafting begins : 2024-12-24	Drafting
BS EN ISO 7864	Sterile hypodermic needles for single use — Requirements and test methods Categories: Unclassified documents Drafting begins : 2024-12-24	Drafting
BS EN ISO 23908	Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods Categories: Syringes, needles and catheters Approval begins : 2024-10-30	Approval

Published (38)

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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 19244:2014	Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters Categories: Medical equipment. General Published standard begins : 2014-08-14	Published standard
PD ISO/PAS 18761:2013	Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure Categories: Medical equipment. General Published standard begins : 2013-02-25	Published standard
BS ISO 23907-2:2019	Sharps injury protection. Requirements and test methods. Reusable sharps containers Categories: Medical equipment. Other Published standard begins : 2019-11-19	Published standard
BS ISO 23217:2024	Injection systems for self-administration by paediatric patients. Requirements and guidelines for design Categories: Syringes, needles and catheters Published standard begins : 2024-02-20	Published standard
BS ISO 20698:2018	Catheter systems for neuraxial application. Sterile and single-use catheters and accessories Categories: Syringes, needles and catheters Published standard begins : 2018-07-27	Published standard
BS ISO 20069:2019	Guidance for assessment and evaluation of changes to drug delivery systems Categories: Medical equipment. General \| Implants for surgery, prosthetics and orthotics Published standard begins : 2019-08-07	Published standard
BS ISO 11608-6:2022	Needle-based injection systems for medical use. Requirements and test methods. On-body delivery systems Categories: Syringes, needles and catheters Published standard begins : 2022-04-25	Published standard
BS ISO 10555-8:2024	Intravascular catheters. Sterile and single-use catheters. Catheters for extracorporeal blood treatment Categories: Syringes, needles and catheters Published standard begins : 2024-08-19	Published standard
BS ISO 10555-7:2023	Intravascular catheters. Sterile and single-use catheters. Peripherally inserted central catheters Categories: Syringes, needles and catheters Published standard begins : 2024-01-12	Published standard
BS EN ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods Categories: Syringes, needles and catheters Published standard begins : 2016-09-05	Published standard

Withdrawn (31)

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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 CR 13825:2000	Luer connectors. A report to CEN CHeF from the CEN forum task group 'Luer fittings' Categories: Transfusion, infusion and injection equipment \| Syringes, needles and catheters Withdrawn begins : 2022-11-17	Withdrawn
BS ISO 10555-6:2015	Intravascular catheters. Sterile and single-use catheters. Subcutaneous implanted ports Categories: Syringes, needles and catheters Withdrawn begins : 2017-12-13	Withdrawn
BS EN ISO 8537:2008	Sterile single-use syringes, with or without needle, for insulin Categories: Syringes, needles and catheters Withdrawn begins : 2016-04-20	Withdrawn
BS EN ISO 8537:1995	Sterile, single-use syringes, with or without needle, for insulin Categories: Syringes, needles and catheters Withdrawn begins : 2008-10-02	Withdrawn
BS EN ISO 7886-4:2009	Sterile hypodermic syringes for single use. Syringes with re-use prevention feature Categories: Syringes, needles and catheters Withdrawn begins : 2019-03-06	Withdrawn
BS EN ISO 7886-4:2006	Sterile hypodermic syringes for single use. Syringes with re-use prevention feature Categories: Syringes, needles and catheters Withdrawn begins : 2009-11-06	Withdrawn
BS EN ISO 7886-3:2009	Sterile hypodermic syringes for single use. Auto-disable syringes for fixed-dose immunization Categories: Syringes, needles and catheters Withdrawn begins : 2020-05-27	Withdrawn
BS EN ISO 7886-3:2005	Sterile hypodermic syringes for single use. Auto-disable syringes for fixed dose immunization Categories: Syringes, needles and catheters Withdrawn begins : 2009-11-06	Withdrawn
BS EN ISO 23907:2012	Sharps injury protection. Requirements and test methods. Sharps containers Categories: Medical equipment. Other Withdrawn begins : 2019-02-13	Withdrawn
BS EN ISO 21649:2009	Needle-free injectors for medical use. Requirements and test methods Categories: Transfusion, infusion and injection equipment Withdrawn begins : 2023-02-10	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

7TP Consultancy Ltd
A B H I - Association of British Healthcare Industries
Association of the British Pharmaceutical Industry
British Healthcare Trades Association
C I W M -Chartered Institute of Wastes Management
Committee Manager
Guild of Healthcare Pharmacists
Healthcare Waste Management Association
Industrial Design Consultancy
Pfizer Limited
Safer Healthcare and Biosafety Network
Swann Morton Ltd
Team Consulting Ltd
University of Plymouth

Liaisons with other committees

Individual Capacity - Combination and Physical Devices
Individual capacity - Device testing and verification
Individual Capacity - Enteral and Intravenous devices
Individual Capacity - Intracoronary catheters
Individual Capacity - Needle-Based Drug Delivery Devices
Individual Capacity - Perioperative practice
Individual Capacity - Product Design
Individual Capacity - Small Bore Connectors Expert
Individual Capacity – Drug Delivery Devices
Liaison - CH/205
Liaison - CH/210/5
UK Expert - ISO/TC 84 WG 12 & 13
UK Expert - ISO/TC 84/WG 11

BSI roles

Committee Chair

Standards Development

CH/84 - Catheters and syringes

Committee standards activity