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NEN EN 14820 : 2004

Current

Current

The latest, up-to-date edition.

SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION

Published date

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
DIN EN 14820 E : 2004 Identical
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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