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BS EN ISO 7886-2:1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterile hypodermic syringes for single use Syringes for use with power-driven syringe pumps
Available format(s)

Hardcopy , PDF

Superseded date

05-20-2020

Language(s)

English

Published date

09-15-1996

Publisher

British Standards Institution

1 Scope
2 Normative references
3 Definitions
4 Nomenclature
5 Cleanliness
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on graduated capacity
10 Graduated scale
11 Syringe design
12 Piston/plunger assembly
13 Nozzle
14 Performance
15 Packaging
16 Labelling
Annexes
A Determination of flow characteristics
B Determination of forces required to move the piston
C Rationale for flowrate characteristics
E Bibliography

Defines requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and over, made from plastics materials to be used with power-driven syringe pumps. Not applicable to syringes to be used with insulin, single use glass syringes, those prefilled with injection by the manufacturer and those supplied as a kit for filling by a pharmacist. Does not deal with compatibility with injection fluids.

Committee
CH/84
DevelopmentNote
Renumbers and supersedes BS ISO 7886-2 (07/2004) 1997 Version incorporates amendment 9835 to BS ISO 7886-2 Supersedes 94/508351 DC (06/2005) Reviewed and confirmed by BSI, November 2007. (10/2007)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 595-2:1987 Reusable all-glass or metal-and-glass syringes for medical use Part 2: Design, performance requirements and tests
EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 595-1:1986 Reusable all-glass or metal-and-glass syringes for medical use Part 1: Dimensions
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 3696:1987 Water for analytical laboratory use — Specification and test methods
IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - 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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Hardcopy - English
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