DIN EN 14820:2004-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION
Hardcopy , PDF
01-12-2017
English
01-01-2004
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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
Provides requirements and test methods for single-use receptacles, intended by their manufacture, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 14820:2004 | Identical |
| NEN EN 14820 : 2004 | Identical |
| BS EN 14820:2004 | Identical |
| SN EN 14820 : 2005 | Identical |
| UNI EN 14820 : 2005 | Identical |
| NS EN 14820 : 1ED 2004 | Identical |
| I.S. EN 14820:2004 | Identical |
| NBN EN 14820 : 2004 | Identical |
| UNE-EN 14820:2005 | Identical |
| NF EN 14820 : 2005 | Identical |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| EN 829 : 1996 | IN VITRO DIAGNOSTIC SYSTEMS - TRANSPORT PACKAGES FOR MEDICAL AND BIOLOGICAL SPECIMENS - REQUIREMENTS, TESTS |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN 14254:2004 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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