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16/30339096 DC : 0

NA
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
Available format(s)

Hardcopy , PDF

Language(s)

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

ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
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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