NF EN ISO 7886-4

NF EN ISO 7886-4

December 2009
Standard Cancelled

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

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. 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. 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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2009

Number of pages

14 p.

Reference

NF EN ISO 7886-4

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-001-4

Print number

1 - 19/11/2009

International kinship

European kinship

EN ISO 7886-4:2009
Sumary
Sterile hypodermic syringes for single use - Part 4 : syringes with re-use prevention feature

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.

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.

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.

Replaced standards (1)
NF EN ISO 7886-4
December 2006
Standard Cancelled
Sterile hypodermic syringes for single use - Part 4 : syringues 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>

Standard replaced by (1)
NF EN ISO 7886-4
March 2019
Standard Current
Sterile hypodermic syringes for single use - Part 4 : syringes with re-use prevention feature

<p>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.</p> <p>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.</p> <p>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.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Nomenclature
    2
  • 5 Types de seringues
    2
  • 6 Propreté
    2
  • 7 Limites d'acidité ou d'alcalinité
    2
  • 8 Teneurs limites en métaux extractibles
    2
  • 9 Lubrifiant
    4
  • 10 Tolérance sur la capacité nominale
    4
  • 11 Échelle graduée
    4
  • 12 Corps
    4
  • 13 Assemblage de la tête et de la tige du piston
    4
  • 14 Embout/aiguille de seringue
    5
  • 15 Performances
    5
  • 16 Emballage
    6
  • 17 Étiquetage
    6
  • Annexe A (normative) Méthode de préparation des extraits
    10
  • Annexe B (normative) Méthode d'essai du dispositif empêchant la réutilisation des seringues qui en sont équipées
    11
  • Annexe C (informative) Aspects environnementaux
    13
  • Bibliographie
    14
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