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PREN 14254 : DRAFT 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS

Superseded date

01-06-2004

Published date

12-01-2013

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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

Specifies requirements and test methods for evacuated and non-evacuated single-use specimen receptacles intended by their manufacturers for the primary containment and preservation of specimens.

Committee
TC 140
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded

Standards Relationship
01/564180 DC : DRAFT OCT 2001 Identical

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