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  • UNI EN ISO 11607-1 : 2014

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    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

    Available format(s): 

    Superseded date:  29-08-2022

    Language(s): 

    Published date:  31-12-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    PREMESSA ALLA NORMA
    PREMESSA ALL'AGGIORNAMENTO A1
    INTRODUZIONE
    1 SCOPO E CAMPO DI APPLICAZIONE
    2 RIFERIMENTI NORMATIVI
    3 TERMINI E DEFINIZIONI
    4 REQUISITI GENERALI
    5 MATERIALI E SISTEMI DI BARRIERA STERILI
      PREFORMATI
    6 REQUISITI DI PROGETTAZIONE E SVILUPPO PER I
      SISTEMI DI IMBALLAGGIO
    7 INFORMAZIONI DA FORNIRE
    APPENDICE A (informativa) - GUIDA AGLI IMBALLAGGI MEDICALI
    APPENDICE B (informativa) - METODI DI PROVA NORMALIZZATI E
                PROCEDURE CHE POSSONO ESSERE UTILIZZATE
                PER DIMOSTRARE LA CONFORMITA AI REQUISITI
                DELLA PRESENTE PARTE DELLA ISO 11607
    APPENDICE C (normativa) - METODO DI PROVA PER LA
                AL PASSAGGIO DELL'ARIA
    APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
                 NORMA EUROPEA E I REQUISITI ESSENZIALI
                 DELLA DIRETTIVA UE 93/42/CEE SUI DISPOSITIVI
                 MEDICI
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Defines the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

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

    Committee U42.12
    Development Note Supersedes UNI EN 868-1. (07/2006) Italian version issued in NOVEMBER 2014. (11/2014)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    UNI/TR 11408 : 2011 GUIDE TO DESIGN, DEVELOPMENT AND CONTROL OF A RECONDITION PROCESS FOR REUSABLE MEDICAL DEVICES THAT SHALL BE STERILIZED BY STEAM

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

    EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
    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 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    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
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    ISO 5636-1:1984 Paper and board Determination of air permeance (medium range) Part 1: General method
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ISO 5636-2:1984 Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
    ISO 5636-5:2013 Paper and board Determination of air permeance (medium range) Part 5: Gurley method
    ISO 186:2002 Paper and board — Sampling to determine average quality
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    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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