BS EN 14820:2004

Superseded

View Superseded by

Single-use containers for human venous blood specimen collection

Available format(s)

Hardcopy , PDF

Superseded date

31-10-2017

Language(s)

English

Published date

08-09-2004

Publisher

British Standards Institution

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.

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.

Committee	CH/212
DevelopmentNote	Supersedes BS ISO 6710 and 01/561851 DC. (09/2004)
DocumentType	Standard
Pages	22
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 6710:2017
Supersedes	BS ISO 6710:1995 01/561851 DC : DRAFT MAY 2001

Standards	Relationship
NBN EN 14820 : 2004	Identical
UNE-EN 14820:2005	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
I.S. EN 14820:2004	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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BS EN 14820:2004

Single-use containers for human venous blood specimen collection

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory