EN 14820:2004

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

This document specifies 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. This document also applies to receptacles containing media for blood culture.This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.