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ISO 15883-1:2006

Current
Current

The latest, up-to-date edition.

Washer-disinfectors Part 1: General requirements, terms and definitions and tests
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Published date

04-06-2006

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.

DevelopmentNote
Supersedes ISO/DIS 15883-1 (04/2006)
DocumentType
Standard
Pages
70
ProductNote
THIS STANDARD ALSO REFERS TO 80/778/EEC,97/23/EEC,SIS - TR 3 This standard is identical to EN ISO 15883-1 :2009
PublisherName
International Organization for Standardization
Status
Current

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
DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
DD CEN ISO/TS 11135-2:2008 Sterilization of health care products. Ethylene oxide Guidance on the application of ISO 11135-1
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
AAMI/ISO TIR17665-3:2014(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
AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
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
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
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.
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.
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
VDI 5700 Blatt 1:2015-04 Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
DIN EN ISO 15883-4:2016-07 (Draft) WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
BS 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
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)
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
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)
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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)
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
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ANSI/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
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)
I.S. EN 13060:2014 SMALL STEAM STERILIZERS
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)
UNI EN ISO 15883-4 : 2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
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)
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
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
VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED 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
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
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
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
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
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
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
ANSI/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
AAMI TIR30:2011(R2016) A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
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)
CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
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
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 13060:2015-03 SMALL STEAM STERILIZERS
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN ISO 4073 : 2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
UNI 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.
UNI EN ISO 15883-3 : 2009 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
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 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
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
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)
CSA Z15883-3 : 2009 : R2014 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
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
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
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
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)
ANSI/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
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)
BS EN ISO 15883-4:2009 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)
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 TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
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)
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)
EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
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
ISO 13504:2012 Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
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 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
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. (ISO 15883-2:2006)
EN ISO 4073:2009 Dentistry - Information system on the location of dental equipment in the working area of the oral health care provider (ISO 4073:2009)
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
BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
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)
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)
DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
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)
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
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
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.
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)
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
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)
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
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
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)
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/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
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 (ISO/TS 17665-2:2009)

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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