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I.S. EN 14820:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

09-24-2017

Language(s)

English

Published date

01-01-2004

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination.

DocumentType
Standard
Pages
21
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 14820 : 2004 Identical
UNE-EN 14820:2005 Identical
BS EN 14820:2004 Identical
EN 14820:2004 Identical
NEN EN 14820 : 2004 Identical
SN EN 14820 : 2005 Identical
UNI EN 14820 : 2005 Identical
NS EN 14820 : 1ED 2004 Identical
NF EN 14820 : 2005 Identical
DIN EN 14820 E : 2004 Identical
DIN EN 14820:2004-11 Identical

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
CLSI H1 A4 : 4ED 96 EVACUATED TUBES AND ADDITIVES FOR BLOOD SPECIMEN COLLECTION
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 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
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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