I.S. EN ISO 7886-1:2018&LC:2018
Current
The latest, up-to-date edition.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
Hardcopy , PDF
English
01-06-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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 singleuse 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.
| Committee |
TC 84
|
| DocumentType |
Test Method
|
| Pages |
50
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. CORRECTED VERSION IS AVAILABLE FOR THIS STANDARD.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 7886-1:2018 | Identical |
| ISO 7886-1:2017 | Identical |
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