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CH/84 - Catheters and syringes

Sector: Governance & Resilience

Categories: Syringes, needles and catheters | Optoelectronics. Laser equipment | Medical equipment. Diagnostic | Medical equipment | Hospital equipment | Colour coding | Construction materials | Sterilization and disinfection | Gas supply | Implants for surgery, prosthetics and orthotics | Medical equipment. General | Medical equipment. Other | Transfusion, infusion and injection equipment | Anaesthetic, respiratory and reanimation equipment | Protective equipment. Other

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 (14)
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: Medical equipment. General

Approval begins : 		Approval
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
ISO/NP 23907-3 Sharps injury protection — Requirements and test methods — Part 3: Part 3: Containers for secure sharps medical waste

Categories: Information management | Standardization. General rules

Proposal begins : 2025-06-17 		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

Drafting begins : 2025-12-22 		Drafting
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: Syringes, needles and catheters

Drafting begins : 2025-09-24 		Drafting
BS EN ISO 8537 Sterile single-use syringes, with or without needle, for insulin

Categories: Syringes, needles and catheters

Drafting begins : 2025-09-26 		Drafting
BS EN ISO 7886-1 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

Categories: Syringes, needles and catheters

Drafting begins : 2025-09-26 		Drafting
BS EN ISO 7864 Sterile hypodermic needles for single use — Requirements and test methods

Categories: Syringes, needles and catheters

Drafting begins : 2025-09-24 		Drafting
Published (33)
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 (36)
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 7886-4:2019 Sterile hypodermic syringes for single use. Syringes with re-use prevention feature

Categories: Syringes, needles and catheters

Withdrawn begins : 2019-05-10 		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 7886-1:2018 Sterile hypodermic syringes for single use. Syringes for manual use

Categories: Syringes, needles and catheters

Withdrawn begins : 2019-10-21 		Withdrawn