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  • UNI EN ISO 11737-1 : 2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS

    Available format(s): 

    Superseded date:  29-08-2022

    Language(s): 

    Published date:  31-12-2005

    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 PER LA QUALITA
    5 SELEZIONE DEL PRODOTTO
    6 METODI PER LA DETERMINAZIONE E LA CARATTERIZZAZIONE
      MICROBICA DELLA CARICA MICROBIOLOGICA
    7 CONVALIDA DEL METODO PER LA DETERMINAZIONE DELLA
      CARICA MICROBIOLOGICA
    8 DETERMINAZIONE SISTEMATICA DELLA CARICA
      MICROBIOLOGICA E INTERPRETAZIONE DEI DATI
    9 MANTENIMENTO DELLA VALIDITA DEL METODO DI
      DETERMINAZIONE DELLA CARICA MICROBIOLOGICA
    APPENDICE A (informativa) - GUIDA PER LA DETERMINAZIONE DI
                 UNA POPOLAZIONE DI MICRORGANISMI SUL PRODOTTO
    APPENDICE B (informativa) - GUIDA SUI METODI DI DETERMINAZIONE
                 DELLA CARICA MICROBIOLOGICA
    APPENDICE C (informativa) - CONVALIDA DEI METODI PER LA CARICA
                 MICROBIOLOGICA
    APPENDICE ZA (informativa) - RAPPORTO TRA LA PRESENTE NORMA
                 EUROPEA E I REQUISITI ESSENZIALI DELLE DIRETTIVE
                 UE 90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI
                 IMPIANTABILI ATTIVI, 93/42/CEE CONCERNENTE I
                 DISPOSITIVI MEDICI E 98/79/CEE CONCERNENTE I
                 DISPOSITIVI MEDICO-DIAGNOSTICI IN VITRO
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.

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

    Development Note Supersedes UNI EN 1174-1, UNI EN 1174-2 and UNI EN 1174-3. (07/2006)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    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 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 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/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 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO/TR 7871:1997 Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
    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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