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
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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 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| 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 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 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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