NF EN ISO 7886-4

NF EN ISO 7886-4

March 2019
Standard Current

Sterile hypodermic syringes for single use - Part 4 : syringes with re-use prevention feature

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2019

Number of pages

23 p.

Reference

NF EN ISO 7886-4

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-001-4

Print number

2 - 01/05/2019

International kinship

ISO 7886-4:2018

European kinship

EN ISO 7886-4:2019
Sumary
Sterile hypodermic syringes for single use - Part 4 : syringes with re-use prevention feature

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.

This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document.

NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Replaced standards (1)
NF EN ISO 7886-4
December 2009
Standard Cancelled
Sterile hypodermic syringes for single use - Part 4 : syringes with re-use prevention feature

<p>ISO 7886-4:2006 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. </p> <p>ISO 7886-4:2006 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in ISO 7886-4:2006.</p> <p>NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with ISO 7886-4:2006 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in ISO 7886-4:2006.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Types de seringues
  • 5 Substances étrangères
  • 6 Lubrifiant
  • 7 Tolérance sur la capacité graduée
  • 8 Échelle graduée
  • 9 Corps
  • 10 Assemblage bouchon-piston/piston
  • 11 Embout/aiguille de seringue
  • 12 Performances
  • 13 Emballage
  • 14 Informations fournies par le fabricant
  • Annexe A (normative) Méthode de préparation des solutions d'essai
  • Annexe B (normative) Méthode d'essai du dispositif empêchant la réutilisation
  • Bibliographie
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