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  • UNI EN ISO 14937 : 2009

    Current The latest, up-to-date edition.

    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

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    Published date:  25-11-2009

    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 RIFERIMENTI NORMATIVI
    3 TERMINI E DEFINIZIONI
    4 ELEMENTI DEL SISTEMA DI GESTIONE DELLA QUALITA
    5 CARATTERIZZAZIONE DELL'AGENTE STERILIZZANTE
    6 CARATTERIZZAZIONE DI PROCESSO E APPARECCHIATURE
    7 DEFINIZIONE DEL PRODOTTO
    8 DEFINIZIONE DEL PROCESSO
    9 CONVALIDA
    10 MONITORAGGIO E CONTROLLO SISTEMATICO
    11 RILASCIO DEL PRODOTTO DALLA STERILIZZAZIONE
    12 MANTENIMENTO DELL'EFFICACIA DEL PROCESSO
    APPENDICE A (normativa) - FATTORI DA CONSIDERARE NELLA
                SELEZIONE DEI MICRORGANISMI PER LA DIMOSTRAZIONE
                DELL'EFFICACIA MICROBICIDA
    APPENDICE B (normativa) - APPROCCIO 1 - DEFINIZIONE DEL
                PROCESSO BASATA SULL'INATTIVAZIONE DELLA
                POPOLAZIONE MICROBICA NEL SUO STATO NATURALE
    APPENDICE C (normativa) - APPROCCIO 2 - DEFINIZIONE DEL
                PROCESSO BASATA SULL'INATTIVAZIONE DI MICRORGANISMI
                DI RIFERIMENTO E SULLE CONOSCENZE DELLA CARICA
                MICROBIOLOGICA
    APPENDICE D (normativa) - APPROCCIO 3 - DEFINIZIONE DEL
                PROCESSO CONSERVATIVO BASATO SULL'INATTIVAZIONE
                DEI MICRORGANISMI DI RIFERIMENTO
    APPENDICE E (informativa) - GUIDA ALL'APPLICAZIONE DELLA
                PRESENTE NORMA INTERNAZIONALE
    APPENDICE ZA (informativa) - RAPPORTO TRA LA PRESENTE NORMA
                 EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
                 UE 90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI
                 IMPIANTABILI ATTIVI
    APPENDICE ZB (informativa) - RAPPORTO TRA LA PRESENTE NORMA
                 EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
                 UE 93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI
    APPENDICE ZC (informativa) - RAPPORTO TRA LA PRESENTE NORMA
                 EUROPEA E I REQUISITI ESSENZIAL I DELLA DIRETTIVA
                 UE 98/79/CEE CONCERNENTE I DISPOSITIVI MEDICI
                 DIAGNOSTICI IN VITRO
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.

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

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

    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/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    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 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 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 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    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 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    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 22442-3:2007 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
    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
    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
    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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