15/30289037 DC : 0

Superseded

View Superseded by

BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

Available format(s)

Hardcopy , PDF

Superseded date

13-04-2018

Language(s)

English

Publisher

British Standards Institution

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Status	Superseded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	BS EN ISO 7886-1:1997

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