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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Single-use containers for human venous blood specimen collection

Available format(s):

Superseded date: 01-09-2017

Language(s):

Published date: 01-09-2004

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

General Product Information - (Show below) - (Hide below)

Committee	CEN/TC 140
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DIN EN 14820:2004-11	Identical
DIN EN 14820 E : 2004	Identical
NBN EN 14820 : 2004	Identical
UNE-EN 14820:2005	Identical
BS 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
I.S. EN 14820:2004	Identical
NF EN 14820 : 2005	Identical
PN EN 14820 : 2009	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

14/30303000 DC : 0	BS EN 16777 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST WITHOUT MECHANICAL ACTION FOR THE EVALUATION OF VIRUCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2/STEP 2)
DIN EN 14563 E : 2009	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF MYCOBACTERICIDAL OR TUBERCULOCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED FOR INSTRUMENTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
BS EN ISO 6710:2017	Single-use containers for human venous blood specimen collection
17/30358087 DC : 0	BS EN 17126 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF SPORICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
16/30348955 DC : 0	BS EN 16777 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST WITHOUT MECHANICAL ACTION FOR THE EVALUATION OF VIRUCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2/STEP 2)
UNI EN 14563 : 2009	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF MYCOBACTERICIDAL OR TUBERCULOCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED FOR INSTRUMENTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
DIN EN 14254 E : 2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
BS EN 14348:2005	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1)
I.S. EN ISO 6710:2017	SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
BS EN 14563:2008	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area. Test method and requirements (phase 2, step 2)
EN ISO 6710:2017	Single-use containers for human venous blood specimen collection (ISO 6710:2017)
PREN 17111 : DRAFT 2017	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF VIRUCIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
I.S. EN 14563:2008	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF MYCOBACTERICIDAL OR TUBERCULOCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED FOR INSTRUMENTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
ISO 6710:2017	Single-use containers for human venous blood specimen collection
DIN EN 14562:2006-08	Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
BS EN 14562:2006	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2)
DIN EN 14563:2009-02	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF MYCOBACTERICIDAL OR TUBERCULOCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED FOR INSTRUMENTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
PREN 16777 : DRAFT 2016	BS EN 16777 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST WITHOUT MECHANICAL ACTION FOR THE EVALUATION OF VIRUCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2/STEP 2)
I.S. EN 14254:2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
DIN EN 14562 E : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
DIN EN 14561 E : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
BS EN 14561:2006	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2)
BS EN 14254:2004	In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
EN 14562 : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
EN 14563 : 2008	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF MYCOBACTERICIDAL OR TUBERCULOCIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED FOR INSTRUMENTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
EN 14348:2005	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
EN 14561 : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
PREN 17126 : DRAFT 2017	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF SPORICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
17/30354236 DC : 0	BS EN 17111 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF VIRUCIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
EN 14254:2004	In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
DIN EN 14348 E : 2005	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF MYCOBACTERICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS IN THE MEDICAL AREA INCLUDING INSTRUMENT DISINFECTANTS - TEST METHODS AND REQUIREMENTS (PHASE 2, STEP 1)
DIN EN 14254:2004-09	In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
DIN EN 14348:2005-04	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
DIN EN 14561:2006-08	Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

Standards Referencing This Book - (Show below) - (Hide below)

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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