ISO 15883-2:2006
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
Available format(s)
Hardcopy , PDF
Language(s)
English, French, Russian
Published date
06-04-2006
Withdrawn date
09-04-2025
Superseded by
€63.00
Excluding VAT
ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1.
The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 15883-2 (04/2006)
|
| DocumentType |
Standard
|
| Pages |
10
|
| ProductNote |
THIS STANDARD ALSO REFERS TO SIS - TR 3
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| UnderRevision |
| Standards | Relationship |
| GOST ISO 15883-2 : 2011 | Identical |
| NBN EN ISO 15883-2 : 2009 | Identical |
| NEN EN ISO 15883-2 : 2009 | Identical |
| NS EN ISO 15883-2 : 2009 | Identical |
| I.S. EN ISO 15883-2:2009 | Identical |
| PN EN ISO 15883-2 : 2010 | Identical |
| SS-EN ISO 15883-2:2009 | Identical |
| BS EN ISO 15883-2:2009 | Identical |
| EN ISO 15883-2:2009 | Identical |
| NF EN ISO 15883-2 : 2009 | Identical |
| DIN EN ISO 15883-2:2009-09 | Identical |
| DS EN ISO 15883-2 : 2009 | Identical |
| ONORM EN ISO 15883-2 : 2009 | Identical |
| UNE-EN ISO 15883-2:2007 | Identical |
| GOST R ISO 15883-2 : 2009 | Identical |
| BS EN ISO 15883-2:2006 | Identical |
| UNE-EN ISO 15883-2:2006 | Identical |
| UNE-EN ISO 15883-2:2009 | Identical |
| 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 |
| 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 |
| AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| 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 |
| 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 |
| 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 |
| 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 |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION 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) |
| ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| 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) |
| 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 |
| 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 |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| 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 |
| AAMI ST65 : 2008 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| 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) |
| AAMI ST15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| I.S. EN ISO 13504:2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| 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 |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| I.S. EN ISO 15883-1:2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| 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 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) |
| 12/30252545 DC : 0 | BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| 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 |
| 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 |
| 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 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| ISO 13504:2012 | Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants — General requirements |
| 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 |
| ISO/TS 11135-2:2008 | Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 |
| BS EN ISO 15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| 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 15883-6:2015 | 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) |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| 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 |
| 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 |
| 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) |
| DIN EN ISO 15883-1:2014-10 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014) (includes Amendment A1:2014) |
| 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/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| 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) |
| ANSI/AAMI ST108:2023 | Water for the processing of medical devices |
| AAMI TIR34:2014(R2021) | Water for the reprocessing of medical devices |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 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) |
| 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) |
| UNE-EN ISO 13504:2013 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
| UNE-EN ISO 15883-1:2009 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| BS 2745-3:1993 | Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| ISO 4017:2014 | Fasteners — Hexagon head screws — Product grades A and B |
| EN 10088-2:2014 | Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| ISO/TS 15883-5:2005 | Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy |
| IEC 61010-2-045:2000 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
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