NF EN ISO 7886-3

NF EN ISO 7886-3

May 2020
Standard Current

Sterile hypodermic syringes for single use - Part 3 : auto-disabled syringes for fixed-dose immunization

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2020

Number of pages

24 p.

Reference

NF EN ISO 7886-3

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-001-3

Print number

1

International kinship

ISO 7886-3:2020

European kinship

EN ISO 7886-3:2020
Sumary
Sterile hypodermic syringes for single use - Part 3 : auto-disabled syringes for fixed-dose immunization

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.

This document does not specify the design of the auto-disable syringe feature.

This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

Replaced standards (1)
NF EN ISO 7886-3
December 2009
Standard Cancelled
Sterile hypodermic syringes for single use - Part 3 : auto-disable syringes for fixed-dose immunization

<p>ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.</p> <p>ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer</p> <p>ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Nomenclature
  • 5 Exigences générales
  • 6 Substances étrangères
  • 7 Lubrifiant
  • 8 Tolérances sur la capacité nominale
  • 9 Échelle graduée
  • 10 Corps
  • 11 Assemblage bouchon-piston/piston
  • 12 Aiguille
  • 13 Performances
  • 14 Emballage
  • 15 Informations fournies par le fabricant
  • Annexe A (normative) Méthode de préparation des solutions d'essai
  • Annexe C (normative) Méthode d'essai pour soumettre à essai le système autobloquant
  • Annexe B (informative) Méthode d'essai des forces nécessaires pour actionner la tête de piston
  • Bibliographie
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