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PREN 14254 : DRAFT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
01-06-2004
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal capacity
6 Marks on the container
6.1 Graduation lines
6.2 Minimum fill line
6.3 Maximum fill line
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Information supplied by the manufacturer
Annex A (normative) Tests for nominal capacity, graduation
lines and minimum free space for non-evacuated
specimen receptacles up to and including 30 ml
nominal capacity
Annex B (normative) Tests for nominal capacity, graduation lines
and minimum free space, for non-evacuated specimen
receptacles of greater than 30 ml nominal capacity
Annex C (normative) Tests for draw volume and minimum free space
for evacuated receptacles
Annex D (normative) Test for leakage from the closure of a
receptacle
Annex E (normative) Test for the robustness of a receptacle
that is intended for centrifugation
Annex ZA (normative) Clauses of this European Standard addressing
essential requirements or other provisions of EU
Directives
Bibliography
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