NF EN ISO 7886-1

NF EN ISO 7886-1

December 1997
Standard Cancelled

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

View the extract
Main informations

Collections

National standards and national normative documents

Publication date

December 1997

Number of pages

33 p.

Reference

NF EN ISO 7886-1

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-001-1

Print number

1 - 01/10/1997

International kinship

ISO 7886-1:1993

European kinship

EN ISO 7886-1:1997
Replaced standards (1)
NF S90-016
January 1984
Standard Cancelled
Medico-surgical equipment. Sterile, single-use hypodermic syringes.

Standard replaced by (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.

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Définitions
    2
  • 4 Nomenclature
    2
  • 5 Propreté
    2
  • 6 Limites d'acidité et d'alcalinité
    2
  • 7 Teneur limite en métaux extractibles
    2
  • 8 Lubrifiant
    2
  • 9 Tolérance sur la capacité graduée
    2
  • 10 Échelle graduée
    4
  • 11 Corps
    5
  • 12 Assemblage tête de piston/piston
    6
  • 13 Embout
    6
  • 14 Performances
    6
  • 15 Emballage
    6
  • 16 Étiquetage
    7
  • Annexe A Méthode de préparation des solutions d'essai
    8
  • Annexe B Méthode d'essai de détection, à l'aspiration, des fuites d'air au niveau de la tête du piston de la seringue, et de séparation de la tête de piston et du piston
    9
  • Annexe C Méthode de détermination de l'espace mort
    11
  • Annexe D Méthode d'essai de détection des fuites de liquide au niveau de la tête du piston de la seringue lors de la compression
    12
  • Annexe E Recommandations relatives aux matériaux
    13
  • Annexe F Exemples de méthodes d'essai permettant de déterminer l'incompatibilité entre les seringues et les liquides injectables
    14
  • Annexe G Méthode d'essai des forces nécessaires pourfaire fonctionner le piston
    18
  • Annexe H Symbole "ne pas réutiliser"
    22
  • Annexe J Bibliographie
    23
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ