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ISO 7886-1 : 2017

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ISO 7886-1 : 2017

STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

International Organization for Standardization

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Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Extraneous matter
7 Lubricant
8 Tolerance on graduated capacity
9 Graduated scale
10 Barrel
11 Plunger stopper/plunger assembly
12 Nozzle
13 Performance
14 Packaging
15 Information supplied by the manufacturer
Annex A (normative) - Method for preparation of
        extracts
Annex B (normative) - Test method for air leakage
        past syringe plunger stopper during aspiration,
        and for separation of plunger stopper and plunger
Annex C (normative) - Method for determination of
        dead space
Annex D (normative) - Test method for liquid leakage
        at syringe plunger stopper under compression
Annex E (informative) - Test method for the
        determination of forces required to operate the
        piston
Annex F (informative) - Test method for the quantity
        of silicone
Bibliography

Abstract

This document 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.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 84
Supersedes
  • ISO 7886 : 1984
  • ISO/DIS 7886-1 : 60.00 (2017)
  • ISO 7886-1 : 1993
  • ISO 7886-1 : 1993 : COR 1