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  • UNE-EN ISO 8536-8:2015

    Current The latest, up-to-date edition.

    Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  11-11-2015

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    1 Scope
    2 Normative references
    3 General requirements
    4 Designation
       4.1 Infusion set
       4.2 Air-inlet device
    5 Materials
    6 Physical requirements
       6.1 Particulate contamination
       6.2 Tensile strength
       6.3 Leakage
       6.4 Male conical fitting
       6.5 Injection site
       6.6 Fluid filter
       6.7 Flow rate of infusion fluid
       6.8 Closure-piercing device
       6.9 Air-inlet device
       6.10 Drip chamber and drip tube
       6.11 Tubing
       6.12 Flow regulator
       6.13 Protective caps
       6.14 Storage volume
    7 Chemical requirements
    8 Biological requirements
    9 Packaging
    10 Labelling
       10.1 Unit container
       10.2 Shelf or multi-unit container
    Annex A (normative) Physical tests
    Annex B (normative) Chemical tests
    Annex C (normative) Biological tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides users information on sterilized infusion sets for single use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

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

    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 8536-9:2015 Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    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
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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