• ONORM EN ISO 11135 : 2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)

    Available format(s): 

    Superseded date:  15-02-2024

    Language(s): 

    Published date:  27-10-2014

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

    Sorry this product is not available in your region.

    Add To Cart

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

    Development Note Supersedes ONORM EN ISO 11135-1 & ONORM CEN ISO/TS 11135-2. (10/2014)
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Superseded
    Superseded By

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

    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 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective