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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
03-06-2018
English
01-01-1998
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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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Superseded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 |
| UNI EN ISO 7886-1 : 1998 | Identical |
| ONORM EN ISO 7886-1 : 1998 | Identical |
| UNE-EN ISO 7886-1:1998 | Identical |
| BS EN ISO 7886-1:1997 | Identical |
| SN EN ISO 7886-1 : 1998 | 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 |
| NS EN ISO 7886-1 : 2018 | Identical |
| EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| ISO 384:2015 | Laboratory glass and plastics ware — Principles of design and construction of volumetric instruments |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
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