Name: CEN ISO/TS 17665-2:2009
Brand: CEN

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)

Published date

15-01-2009

Publisher

Comite Europeen de Normalisation

ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.

Committee	CEN/TC 204
DocumentType	Technical Specification
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
S.R. CEN ISO/TS 17665-2:2009	Identical
SNR CEN ISO/TS 17665-2 : 2017	Identical
UNE-CEN ISO/TS 17665-2:2009 EX	Identical
SIS-CEN ISO/TS 17665-2:2009	Identical
UNI CEN ISO/TS 17665-2 : 2009	Identical
NF CEN ISO/TS 17665-2 : 2009	Identical
ISO/TS 17665-2:2009	Identical
NEN NPR CEN ISO/TS 17665-2 : 2009	Identical
DD CEN ISO/TS 17665-2:2009	Identical

PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
I.S. EN 285:2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN 556-2:2015-11	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
BS EN 556-2:2015	Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
DIN EN 285:2016-05	Sterilization - Steam sterilizers - Large sterilizers
UNE-EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
I.S. EN ISO 25539-1:2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
STANAG 2906 : 2015	ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS
UNE-EN 556-2:2016	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
BS EN 285:2015	Sterilization. Steam sterilizers. Large sterilizers
EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
EN 556-2:2015	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
BS EN ISO 25539-1:2017	Cardiovascular implants. Endovascular devices Endovascular prostheses
BS EN ISO 7198:2017	Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
I.S. EN 556-2:2015	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
I.S. EN ISO 7198:2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
UNE-EN 285:2016	Sterilization - Steam sterilizers - Large sterilizers

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
ISO 15883-1:2006	Washer-disinfectors Part 1: General requirements, terms and definitions and tests
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11138-3:2017	Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 15882:2008	Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
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
EN 868-5:2009	Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
BS EN 12442-3:2000	Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
BS EN 12442-2:2000	Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
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
EN 867-5:2001	Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
ISO/TR 14969:2004	Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 11140-3:2007	Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
ISO/TS 15883-5:2005	Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 3746:2010	Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
ISO 11140-4:2007	Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
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 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 11140-5:2007	Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
BS EN 12442-1:2000	Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ANSI/AAMI ST79:2017	COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 14040:2006	Environmental management Life cycle assessment Principles and framework
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.
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN 13060:2014	Small steam sterilizers
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