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  • DIN EN ISO 22442-3:2008-03

    Current The latest, up-to-date edition.

    MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2008

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

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Allgemeine Anforderungen
      4.1 Risikomanagement
      4.2 Verfahren der Beschaffung und Herstellung
      4.3 Allgemeine Anforderungen in Bezug auf
          die Validierung
          4.3.1 Dokumentierte Verfahren
          4.3.2 Personal
          4.3.3 Kalibrierung
          4.3.4 Ausrüstung
          4.3.5 Experimentelle Systeme
    5 Literaturrecherche
      5.1 Durchführung der Literaturrecherche
      5.2 Anwendung der Ergebnisse der Literaturrecherche
      5.3 Viren
      5.4 Infektiöse TSE-Materialien
    6 Eliminierungs- und/oder Inaktivierungsstudie für
      Viren und infektiöses TSE-Material
      6.1 Allgemeines
      6.2 Prüfplan
      6.3 Durchführung der Studie
      6.4 Auswertung der Daten
    7 Abschlussbericht
    8 Überprüfung des Abschlussberichtes
    9 Routineüberwachung und Kontrolle von
      kritischen Prozessparametern
    Anhang A (normativ) Anforderungen an die Literaturrecherche
                          und -bewertung
          A.1 Allgemeines
              A.1.1 Methodik
              A.1.2 Kritische Bewer
          A.2 Schlussfolgerungen
          A.3 Bericht
    Anhang B (informativ) Anleitung zur Eliminierungs- und/oder
                           Inaktivierungsstudie für Viren
          B.1 Allgemeines
          B.2 Auswahl der Viren
          B.3 Design und Umsetzung von Eliminierungs- und/oder
              Inaktivierungsstudien
              B.3.1 Allgemeines
              B.3.2 Design der Studie
              B.3.3 Kultivierung von Modellviren
              B.3.4 Durchführung von Prüfungen mit Zellkulturen
              B.3.5 Reduktionsfaktoren
          B.4 Grenzen der Eliminierungs- und/oder
              Inaktivierungsstudien
    Anhang C (informativ) Anleitung zur Eliminierungs- und/oder
                           Inaktivierungsstudie für
                           infektiöse TSE-Materialien
          C.1 Allgemeines
          C.2 Infektiöse TSE-Materialien, die nicht vom
              Inaktivierungsschritt erfasst wurden
    Anhang D (informativ) Anleitung zur Einrichtung eines
                           Verfahrens in massstabsgerechter
                           Verkleinerung (scaling down)
    Anhang E (informativ) Statistische Auswertung der Virustiter
                           und Reduktionsfaktoren und Bewertung
                           von deren Validität
    Anhang F (informativ) Berechnung von Reduktionsfaktoren
    Anhang G (informativ) Nachweiswahrscheinlichkeit von
                           Erregern bei geringen Konzentrationen
    Anhang ZA (informativ) Zusammenhang zwischen dieser
                           Europäischen Norm und den
                           grundlegenden Anforderungen der
                           durch die Richtlinie der Kommission
                           2003/32/EG geänderten EG-Richtlinie
                           93/42/EWG über Medizinprodukte
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 406. Describes requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable.

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

    Development Note Supersedes DIN EN 12442-3. (03/2008)
    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 EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    DIN HDBK 406 : 2ED 2016
    DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    DIN EN ISO 14160:2011-10 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
    DIN EN ISO 11137-1:2015-11 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)

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

    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    DIN EN ISO 22442-2:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    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
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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