16/30339096 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Requirements
6 Cleanliness
7 Limits for acidity or alkalinity
8 Limits for extractable metals
9 Lubricant
10 Tolerance on nominal capacity
11 Graduated scale
12 Barrel
13 Plunger stopper/plunger assembly
14 Needle
15 Performance
16 Packaging
17 Information supplied by the manufacturer
Annex A (normative) - Method for preparation
of extracts
Annex B (informative) - Test method for forces
required to operate piston
Annex C (normative) - Test method for testing
auto-disable feature
Bibliography
BS EN ISO 7886-3.
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
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| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
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| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| 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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