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  • ISO 15883-1:2006

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    Washer-disinfectors Part 1: General requirements, terms and definitions and tests

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s): 

    Published date:  06-04-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.

    The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.

    ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.

    ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.

    The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

    ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

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

    Committee ISO/TC 198
    Development Note Supersedes ISO/DIS 15883-1 (04/2006)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO 80/778/EEC,97/23/EEC,SIS - TR 3 This standard is identical to EN ISO 15883-1 :2009
    Publisher International Organization for Standardization
    Status Current

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

    DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    DIN EN ISO 20857 E : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    BS EN ISO 20857:2013 (published 2013-04) Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
    12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
    BS EN 16442 : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    ISO 15883-7:2016 Washer-disinfectors Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    AAMI TIR52 : 2014 : R2017 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    I.S. EN 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
    AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    CSA Z15883-5:09 (R2019) Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (Adopted ISO/TS 15883-5:2005, first edition, 2005-11-15)
    UNE-EN ISO 13504:2013 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
    16/30288024 DC : 0 BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    14/30235350 DC : 0 BS EN ISO 15883-7 - WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
    CSA Z15883-3 : 2009 : R2014 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 5700-1 : 2015 REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - MEASURES FOR RISK CONTROL
    DD CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    CSA Z15883-3:09 (R2019) WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    UNI EN ISO 13504 : 2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
    09/30196750 DC : DRAFT MAY 2009 BS EN ISO 15883-6 - WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    BS PD ISO/TS 17665-3 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    CAN/CSA-ISO 15883-6:17 Washer-disinfectors Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive , non-critical medical devices and healthcare equipment (Adopted ISO 15883-6:2011, first edition, 2011-04-15)
    11/30212235 DC : 0 BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    CAN/CSA-ISO 15883-7:17 Washer-disinfectors Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
    DD CEN ISO/TS 11135-2 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 (ISO/TS 11135-2:2008)
    S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    16/30280931 DC : DRAFT APR 2016 BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
    04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    CSA Z11135-2 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    CSA Z11135-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    AAMI 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
    AAMI 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
    08/30173546 DC : DRAFT JAN 2008 BS ISO 4073 - DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    CSA Z15883-2 : 2009 : R2014 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    CSA Z11135-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    CSA Z15883-4 : 2009 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008, IDT)
    AAMI ISO 20857 : 2010 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    AAMI ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    BS EN ISO 15883-4:2009 (published 2009-09) Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
    AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    AAMI ST58 : 2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    AAMI ISO TIR 17665-3 : 2014 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    NBR ISO 15883-2 : 2013 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    I.S. EN ISO 15883-4:2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    AAMI ISO TIR 17665-2 : 2009 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    I.S. CEN ISO TS 15883-5:2006 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    EN 13060:2014 SMALL STEAM STERILIZERS
    AAMI ISO 17665-1 : 2006 : R2013 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNI CEN ISO/TS 11135-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    AAMI ST65 : 2008 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z15883-3:09 (R2019) Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (Adopted ISO 15883-3:2006, first edition, 2006-04-15, with Canadian deviations)
    AAMI ST65 : 2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    AAMI TIR30 : 2011 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
    CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z15883-2 : 2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    CSA Z15883-4 : 2009 : R2014 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    CSA Z15883-5 : 2009 : R2014 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    S.R. CEN ISO TS 11135-2:2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    UNE-EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    BS EN ISO 15883-6:2015 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
    DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    UNI EN ISO 15883-4 : 2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    CEN ISO/TS 15883-5 : 2005 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    AAMI ISO TIR 11135-2 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1
    PREN ISO 15883-6 : DRAFT 2009 WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    UNE-EN 13060:2015 Small steam sterilizers
    I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    I.S. EN ISO 13504:2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
    I.S. EN ISO 15883-6:2015 WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-6:2011)
    BS EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    AAMI ST65 : 2008 : R2013 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    BS EN ISO 13504 : 2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    AAMI TIR30 : 2011 : R2016 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    EN ISO 15883-4:2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    ISO/TS 17665-3:2013 Sterilization of health care products Moist heat Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
    DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    DIN EN ISO 15883-2:2009-09 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    DIN EN ISO 15883-3:2009-09 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    DIN EN ISO 4073:2009-10 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    ISO 13504:2012 Dentistry General requirements for instruments and related accessories used in dental implant placement and treatment
    BS EN ISO 15883-2:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    BS EN 1639 : 2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
    ISO 15883-6:2011 Washer-disinfectors Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
    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 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    ISO 4073:2009 Dentistry Information system on the location of dental equipment in the working area of the oral health care provider
    UNE-EN ISO 4073:2010 Dentistry - Information system on the location of dental equipment in the working area of the oral health care provider (ISO 4073:2009)
    BS EN ISO 17665-1:2006 (published 2006-09) Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for 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
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    BS EN 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    BS EN ISO 15883-3:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    I.S. EN ISO 15883-2:2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    I.S. EN ISO 4073:2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    I.S. EN ISO 15883-3:2009 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    CEN ISO/TS 11135-2:2008/AC:2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    DIN EN ISO 15883-4:2009-09 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
    EN ISO 15883-7 : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    EN ISO 15883-2:2009 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    EN ISO 4073:2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    EN ISO 15883-6:2015 WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-6:2011)
    EN 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 (ISO 17665-1:2006)
    EN ISO 13504 : 2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    EN 16442 : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES

    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
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    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 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1717 : 2000 PROTECTION AGAINST POLLUTION OF POTABLE WATER IN WATER INSTALLATIONS AND GENERAL REQUIREMENTS OF DEVICES TO PREVENT POLLUTION BY BACKFLOW
    ISO 12100:2010 Safety of machinery General principles for design Risk assessment and risk reduction
    AS 2773:2019 Ultrasonic cleaners for health service organisations
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 13849-2:2012 Safety of machinery Safety-related parts of control systems Part 2: Validation
    DIN 58955-3:1998-09 DECONTAMINATION-APPARATUS IN THE MEDICAL FIELD - EFFICIENCY TESTING
    IEC 80416-1:2008 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: CREATION OF GRAPHICAL SYMBOLS FOR REGISTRATION
    ISO 10012:2003 Measurement management systems Requirements for measurement processes and measuring equipment
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 9001:2015 Quality management systems Requirements
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products Biological indicators Part 1: General requirements
    EN 1822-1 : 2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    DIN 10510:2013-10 FOOD HYGIENE - COMMERCIAL DISHWASHING WITH MULTITANK-TRANSPORTDISHWASHERS - HYGIENE REQUIREMENTS, PROCEDURE TESTING
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    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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