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  • BS EN 14820:2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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    Superseded date:  31-10-2017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

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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)

    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.

    Scope - (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 CH/212
    Development Note Supersedes BS ISO 6710 and 01/561851 DC. (09/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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