M00023949
New product
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
International Organization for Standardization
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Availability date: 11/05/2021
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
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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 84 |
Supersedes |
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