• 01/564180 DC : DRAFT OCT 2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS

    Available format(s): 

    Superseded date:  06-07-2004

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Nominal capacity
    6 Marks on the container
       6.1 Graduation lines
       6.2 Minimum fill line
       6.3 Maximum fill line
    7 Design
    8 Construction
    9 Sterility and special microbiological states
    10 Additives
    11 Information supplied by the manufacturer
    Annex A (normative) Tests for nominal capacity, graduation
            lines and minimum free space for non-evacuated
            specimen receptacles up to and including 30 ml
            nominal capacity
    Annex B (normative) Tests for nominal capacity, graduation lines
            and minimum free space, for non-evacuated specimen
            receptacles of greater than 30 ml nominal capacity
    Annex C (normative) Tests for draw volume and minimum free space
            for evacuated receptacles
    Annex D (normative) Test for leakage from the closure of a
            receptacle
    Annex E (normative) Test for the robustness of a receptacle
            that is intended for centrifugation
    Annex ZA (normative) Clauses of this European Standard addressing
             essential requirements or other provisions of EU
             Directives
    Bibliography

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

    Comment Closes On
    Committee CH/29
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 4788:2005 Laboratory glassware Graduated measuring cylinders
    ISO 6710:2017 Single-use containers for human venous blood specimen collection
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    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
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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