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  • BS ISO 22413:2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Transfer sets for pharmaceutical preparations. Requirements and test methods

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2011

    Language(s):  English

    Published date:  31-07-2010

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Design and designation
    4 Material
    5 Physical requirements
    6 Chemical requirements
    7 Biological requirements
    8 Testing of physical requirements
    9 Testing of chemical requirements
    10 Testing of biological requirements
    11 Packaging
    12 Storage
    13 Labelling
    Annex A (normative) - Testing of fragmentation of
                          transfer sets with plastic
                          piercing devices
    Annex B (normative) - Testing of fragmentation of
                          transfer sets with metal
                          piercing devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to sterilized single use transfer sets that are used for pharmaceutical preparations.

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

    Committee CH/212
    Development Note Supersedes 05/30135133 DC. (03/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 15759:2005 Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
    DIN 13097-4:2009-08 HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 15747:2010 Plastic containers for intravenous injections
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