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NBN EN ISO 7886-1 : 1997

Current

Current

The latest, up-to-date edition.

STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

Published date

01-12-2013

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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 Barrel
12 Piston/plunger assembly
13 Nozzle
14 Performance
15 Packaging
16 Labelling
Annexes
A Method for preparation of extracts
B Test method for air leakage past syringe piston during
    aspiration, and for separation of piston and plunger
C Method for determination of dead space
D Test method for liquid leakage at syringe piston
    under compression
E Guidance on materials
F Examples of test methods for incompatibility between
    syringes and injection fluids
G Test method for forces required to operate plunger
H Symbol for "do not use"
J Bibliography

Defines requirements for sterile single-use hypodermic plastic syringes for aspiration or injecting of fluids immediately after filling. Does not include syringes to be used with insulin, single-use glass syringes, syringes used with power-driven syringe pumps, prefilled with injection by the manufacturer or supplied as a kit for filling by a pharmacist.

DocumentType
Standard
PublisherName
Belgian Standards
Status
Current

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