I.S. EN ISO 7886-3:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
Hardcopy , PDF
11-30-2020
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Cleanliness
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on nominal capacity
10 Graduated scale
11 Barrel
12 Piston/plunger assembly
13 Needle
14 Performance
15 Packaging
16 Labelling
Annex A (normative) Method for preparation of extracts
Annex B (informative) Test method for forces required
to operate plunger
Annex C (normative) Test method for testing auto-disable
feature
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
Bibliography
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