PD ISO/TS 17665-3:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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
Hardcopy , PDF
02-01-2024
English
12-31-2013
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Product family (pf)
6 Processing category
7 Sterilization process parameters
8 Additional considerations
Annex A (informative) - Process parameters
Annex B (informative) - Characterization of a
procedure set - Examples
Annex C (informative) - Designating a processing
category
Annex D (informative) - Processing categories
- Examples
Bibliography
Specifies guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of indentifying the aligning it to a processing category for a specific moist head sterilization process.
| Committee |
CH/198
|
| DocumentType |
Standard
|
| Pages |
62
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.
NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO17664).
| Standards | Relationship |
| ISO/TS 17665-3:2013 | Identical |
| 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 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| 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 |
| EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| 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 |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: 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 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 |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| 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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