NEN EN 14820 : 2004
Current
The latest, up-to-date edition.
SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal liquid capacity
6 Graduation and fill lines
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Information supplied by the manufacturer
12 Receptacle and additive identification
Annex A (normative) Test for nominal liquid capacity and
graduation marks, for non-evacuated
blood specimen receptacles
A.1 Reagents and apparatus
A.2 Test conditions
A.3 Test procedure
Annex B (normative) Tests for draw volume for evacuated
receptacles
B.1 Reagents and apparatus
B.2 Test conditions
B.3 Test procedure
Annex C (normative) Test for leakage from the closure of a
receptacle
C.1 Reagents and apparatus
C.2 Test procedure for non-evacuated container
C.3 Test procedure for evacuated receptacles
Annex D (normative) Test for the robustness of a receptacle
that is intended for centrifugations
D.1 Reagents and apparatus
D.2 Test conditions
D.3 Test procedure
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directive 98/79/EC
Bibliography
Describes requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. Also applicable to receptacles containing media for blood culture.
DocumentType |
Standard
|
PublisherName |
Netherlands Standards
|
Status |
Current
|
Standards | Relationship |
BS EN 14820:2004 | Identical |
I.S. EN 14820:2004 | Identical |
UNE-EN 14820:2005 | Identical |
DIN EN 14820:2004-11 | Identical |
EN 14820:2004 | Identical |
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