15/30289037 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
Hardcopy , PDF
English
13-04-2018
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) - Examples of test methods for
incompatibility between syringes and injection fluids
Annex F (normative) Test method for forces required to
operate plunger
Annex G (informative) - Test method for the quantity of silicone
Bibliography
BS EN ISO 7886-1.
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
43
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| 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 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
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