ISO 7864:2016
Sterile hypodermic needles for single use — Requirements and test methods
ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Statistics and reproducibility of test methods
4.3 Cleanliness
4.4 Limits for acidity or alkalinity
4.5 Limits for extractable metals
4.6 Size designation
4.6.1 Tubular needle designation
4.6.2 Tapered needle designation
4.7 Colour coding
4.8 Needle hub
4.8.1 Conical fitting
4.8.2 Colour of hub
4.9 Needle cap
4.10 Needle tube
4.10.1 General
4.10.2 Tolerances on length
4.10.3 Freedom from defects
4.10.4 Lubricant
4.11 Needle point
4.12 Bond between hub and needle tube
4.13 Patency of lumen
4.14 Sharps injury protection
4.15 Sterility and biocompatibility
4.15.1 Sterility
4.15.2 Biocompatibility
5 Packaging
5.1 Unit packaging
5.2 User packaging
6 Information supplied by the manufacturer
6.1 General
6.2 Unit packaging
6.3 User packaging
6.4 Storage container
6.5 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (informative) Fragmentation test for medical needles
Annex C (informative) Determination of flow rate through the needle
Annex D (informative) Test method for measuring the penetration force and drag force for needles
Annex E (informative) Needle bonding strength test method
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Statistics and reproducibility of test methods
4.3 Cleanliness
4.4 Limits for acidity or alkalinity
4.5 Limits for extractable metals
4.6 Size designation
4.6.1 Tubular needle designation
4.6.2 Tapered needle designation
4.7 Colour coding
4.8 Needle hub
4.8.1 Conical fitting
4.8.2 Colour of hub
4.9 Needle cap
4.10 Needle tube
4.10.1 General
4.10.2 Tolerances on length
4.10.3 Freedom from defects
4.10.4 Lubricant
4.11 Needle point
4.12 Bond between hub and needle tube
4.13 Patency of lumen
4.14 Sharps injury protection
4.15 Sterility and biocompatibility
4.15.1 Sterility
4.15.2 Biocompatibility
5 Packaging
5.1 Unit packaging
5.2 User packaging
6 Information supplied by the manufacturer
6.1 General
6.2 Unit packaging
6.3 User packaging
6.4 Storage container
6.5 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (informative) Fragmentation test for medical needles
Annex C (informative) Determination of flow rate through the needle
Annex D (informative) Test method for measuring the penetration force and drag force for needles
Annex E (informative) Needle bonding strength test method
Bibliography