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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded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