• DIN EN ISO 8871-1:2004-11

    Current The latest, up-to-date edition.

    ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES

    Available format(s):  Hardcopy, PDF

    Language(s):  German

    Published date:  01-01-2004

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    FOREWORD
    1 Scope
    2 Normative reference
    3 Terms and definitions
    4 Symbols
    5 Currents during two separate simultaneous line-to-earth
      short circuits
      5.1 Calculation method
          5.1.1 Initial symmetrical short-circuit current
          5.1.2 Peak short-circuit current, symmetrical
                short-circuit breaking current and steady-state
                short-circuit current
          5.1.3 Distribution of line-to-earth short-circuit
                currents during two separate simultaneous
                line-to-earth short circuits
    6 Partial short-circuit currents flowing through earth in
      the case of an unbalanced short circuit
      6.1 Calculation method
          6.1.1 General
          6.1.2 Line-to-earth short circuit in a station
          6.1.3 Line-to-earth short circuit far outside a station
          6.1.4 Line-to-earth short circuit in the vicinity of a
                station
          6.1.5 Reduction factor for overhead lines and cables
    Annex A (informative) Example for the calculation of two
                          separate simultaneous line-to-earth
                          short-circuit currents
    Annex B (informative) Examples for the calculation of partial
                          short-circuit currents through earth
    Annex ZA (normative) Normative references to international
                          publications with their corresponding
                          European publications

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 231. Describes procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.

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    Development Note Supersedes DIN 58367-2 and DIN ISO 8871 (11/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN ISO 8536-6:2017-09 INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
    DIN ISO 8536-6:2012-09 INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
    DIN EN ISO 8362-5 E : 2016 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)
    DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    DIN ISO 11040-2 E : 2012 PREFILLED SYRINGES - PART 2: PLUNGER STOPPERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-2:2011)
    DIN EN ISO 8362-2:2016-02 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
    DIN EN ISO 8871-2:2014-08 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
    DIN ISO 8362-5:2011-06 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS
    DIN ISO 15759:2006-05 Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process (ISO 15759:2005)
    DIN ISO 11040-5:2013-12 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
    DIN EN ISO 8362-5:2016-07 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)
    DIN HDBK 231 : 4ED 2012
    DIN ISO 11040-5 E : 2013 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
    DIN ISO 11040-2:2012-10 Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges (ISO 11040-2:2011)
    DIN ISO 8536-12:2013-04 Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    DIN EN ISO 8536-2:2010-08 Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
    DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    DIN ISO 13926-2:2012-09 PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE (ISO 13926-2:2011)
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