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ONORM EN 14254 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
23-12-2021
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal liquid capacity
6 Graduation and fill lines
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
A.1 Reagents and apparatus
A.2 Test Conditions
A.3 Test procedure
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
B.1 Reagents and apparatus
B.2 Test conditions
B.3 Test procedures
Annex C (normative) Tests for draw volume and minimum free
space for evacuated receptacles
C.1 Reagents and apparatus
C.2 Test conditions
C.3 Test procedure
Annex D (normative) Test for leakage from the closure of
a receptacle
D.1 Reagents and apparatus
D.2 Test procedure for non-evacuated receptacles intended
for storage above 0 degree C
D.3 Test procedure for non-evacuated receptacles intended
for storage at 0 degree C or below
D.4 Test procedure for evacuated receptacles
Annex E (normative) Test for the robustness of a receptacle
that is intended for centrifugation
E.1 Reagents and apparatus
E.2 Test conditions
E.3 Test procedure
Annex ZA (informative) Relationship between this European
Standard and the Essential
Requirements of EU Directive 98/79/EC
Bibliography
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