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  • DIN EN ISO 11135-1:2007-08

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-10-2014

    Language(s):  English

    Published date:  01-01-2007

    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 Qualitätsmanagementsysteme
       4.1 Dokumentation
       4.2 Verantwortlichkeit der Leitung
       4.3 Produktrealisierung
       4.4 Messung, Analyse und Verbesserung - Lenkung
           fehlerhafter Produkte
    5 Charakterisierung des sterilisierenden Agens
       5.1 Sterilisierendes Agens
       5.2 Keimabtötende Wirkung
       5.3 Auswirkungen auf Materialien
       5.4 Überlegungen zur Umwelt
    6 Charakterisierung von Verfahren und Ausrüstung
       6.1 Charakterisierung des Verfahrens
       6.2 Charakterisierung der Ausrüstung
    7 Produktdefinition
       7.1 Allgemeines
       7.2 Produktsicherheit und Produktleistung
       7.3 Mikrobiologische Qualität
       7.4 Dokumentation
    8 Verfahrensdefinition
    9 Validierung
       9.1 Abnahmebeurteilung
       9.2 Funktionsbeurteilung
       9.3 Leistungsbeurteilung
       9.4 Wechselnde Konfigurationen der Beladung
       9.5 Überprüfung und Bestätigung der Validierung
    10 Lenkung der Anwendung und Kontrolle
    11 Produktfreigabe nach der Sterilisation
    12 Aufrechterhaltung der Wirksamkeit des Verfahrens
       12.1 Allgemeines
       12.2 Instandhaltung der Ausrüstung
       12.3 Erneute Beurteilung
       12.4 Beurteilung von Veränderungen
    Anhang A (normativ) Bestimmung der keimabtötenden
                           Wirkung des Prozesses - Verfahren mit
                           biologischen Indikatoren und der
                           Keimbelastung
    Anhang B (normativ) Konservative Bestimmung der keimabtötenden
                           Wirkung des Prozesses - Keimabtötung
                           über das übliche Mass hinaus ('Overkill')
    Anhang C (informativ) Allgemeiner Leitfaden
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen dieser
                           Europäischen Norm und den
                           grundlegenden Anforderungen der
                           EG 93/42/EWG über Medizinprodukte

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 169, 267/2, 268 and 263. Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

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

    Development Note Supersedes DIN EN ISO 11135 issue 08-2004. (01/2006) Supersedes DIN 58948-6, DIN EN 550. (08/2007)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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    DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
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    DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
    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 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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    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 HDBK 263 : 4ED 2014
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    DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
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    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    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 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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