NF EN ISO 7886-1

NF EN ISO 7886-1

March 2018
Standard Current

Sterile hypodermic syringes for single use - Part 1 : syringes for manual use

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2018

Number of pages

40 p.

Reference

NF EN ISO 7886-1

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-001-1

Print number

2 - 01/07/2020

International kinship

ISO 7886-1:2017

European kinship

EN ISO 7886-1:2018
Sumary
Sterile hypodermic syringes for single use - Part 1 : syringes for manual use

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.

Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.

It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).

Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

Replaced standards (1)
NF EN ISO 7886-1
December 1997
Standard Cancelled
Sterile hypodermic syringes for single use. Part 1 : syringes for manual use.

Table of contents
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  • Avant-propos européen
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Nomenclature
  • 5 Exigences générales
  • 6 Substances étrangères
  • 7 Lubrifiant
  • 8 Tolérance sur la capacité graduée
  • 9 Échelle graduée
  • 10 Corps
  • 11 Assemblage bouchon-piston/piston
  • 12 Embout
  • 13 Performance
  • 14 Emballage
  • 15 Informations fournies par le fabricant
  • Annexe A (normative) Méthode de préparation des solutions d'essai
  • Annexe B (normative) Méthode d'essai permettant de détecter, à l'aspiration, des fuites d'air au niveau du bouchon-piston de la seringue et un détachement du bouchon-piston du piston
  • Annexe C (normative) Méthode de détermination de l'espace mort
  • Annexe D (normative) Méthode d'essai permettant de détecter des fuites de liquide au niveau du bouchon-piston de la seringue sous compression
  • Annexe E (informative) Méthode d'essai permettant de déterminer les forces requises pour actionner la tête de piston
  • Annexe F (informative) Méthode d'essai permettant de déterminer la quantité de silicone
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE [JO L 169]
  • Bibliographie
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