I.S. EN ISO 7886-1:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
Hardcopy , PDF
English
01-01-1998
03-06-2018
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.
National Foreword
European foreword
Endorsement notice
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
Defines requirements for sterile single-use hypodermic plastic syringes for aspiration or injecting of fluids immediately after filling. Does not include syringes to be used with insulin, single-use glass syringes, syringes used with power-driven syringe pumps, prefilled with injection by the manufacturer or supplied as a kit for filling by a pharmacist.
| DevelopmentNote |
2018 edition incorporates corrigendum 2018. (05/2018)
|
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN ISO 7886-1:1997 | Identical |
| ISO 7886-1:2017 | Identical |
| NEN EN ISO 7886-1 : 1997 | Identical |
| NF EN ISO 7886-1 : 1997 | Identical |
| DIN EN ISO 7886-1:2015-10 (Draft) | Identical |
| NBN EN ISO 7886-1 : 1997 | Identical |
| BS EN ISO 7886-1:2018 | Identical |
| UNE-EN ISO 7886-1:1998 | Identical |
| NS EN ISO 7886-1 : 2018 | Identical |