ISO 80369-7:2021
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General requirements for Luer connectors
4.2 Type tests
5 Dimensional requirements for Luer connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Sub-atmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding
Annex A (informative) Rationale and guidance
Annex B (normative) Luer connectors
Annex C (normative) Reference connectors
Annex D (informative) Assessment of medical devices and their attributes with connections within this application
Annex E (informative) Summary of the usability requirements for Luer connectors for intravascular or hypodermic applications
Annex F (informative) Summary of Luer connector design requirements for intravascular or hypodermic applications
Annex G (informative) Summary of assessment of the design of the Luer connector for intravascular or hypodermic applications
Annex H (informative) Reference to the essential principles
Annex I (informative) Reference to the general safety and performance requirements
Annex J (informative) Terminology — Alphabetized index of defined terms
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General requirements for Luer connectors
4.2 Type tests
5 Dimensional requirements for Luer connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Sub-atmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding
Annex A (informative) Rationale and guidance
Annex B (normative) Luer connectors
Annex C (normative) Reference connectors
Annex D (informative) Assessment of medical devices and their attributes with connections within this application
Annex E (informative) Summary of the usability requirements for Luer connectors for intravascular or hypodermic applications
Annex F (informative) Summary of Luer connector design requirements for intravascular or hypodermic applications
Annex G (informative) Summary of assessment of the design of the Luer connector for intravascular or hypodermic applications
Annex H (informative) Reference to the essential principles
Annex I (informative) Reference to the general safety and performance requirements
Annex J (informative) Terminology — Alphabetized index of defined terms
Bibliography