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  • UNI EN ISO 17664 : 2005

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES

    Available format(s): 

    Superseded date:  04-09-2022

    Language(s): 

    Published date:  31-12-2004

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    PREMESSA
    INTRODUZIONE
    1 SCOPO E CAMPO DI APPLICAZIONE
    2 TERMINI E DEFINIZIONI
    3 INFORMAZIONI CHE DEVONO ESSERE FORNITE DAL
      FABBRICANTE DEL DISPOSITIVO MEDICO
    4 PRESENTAZIONE DELLE INFORMAZIONI
    5 VALIDAZIONE DELLE INFORMAZIONI FORNITE SUI PROCESSI RIPETUTI
    6 ANALISI DEL RISCHIO
    APPENDICE A (informativa) - METODI DI UTILIZZO COMUNE PER I
      PROCESSI RIPETUTI
    APPENDICE B (informativa) - ESEMPIO DI ISTRUZIONI SUI PROCESSI
      RIPETUTI PER DISPOSITIVI MEDICI RIUTILIZZABILI
    APPENDICE ZA (informativa) - PUNTI DELLA PRESENTE NORMA EUROPEA
      RIGUARDANTI REQUISITI ESSENZIALI O ALTRE DISPOSIZIONI DELLE
      DIRETTIVE UE
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.

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

    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By

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

    EN 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 14937:2009)
    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
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    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 11607:2003 Packaging for terminally sterilized medical devices
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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