ANSI/AAMI/ISO 17664:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
English
18-08-2017
15-01-2024
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
ISO 17664:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified in
the information provided by the medical
device manufacturer
5 Risk analysis
6 Information to be provided by the
medical device manufacturer
7 Presentation of the information
Annex A (informative) - Commonly utilized
processing methods
Annex B (informative) - Example of processing
instructions for reusable medical devices
Annex C (informative) - Classification of medical
devices
Annex D (informative) - Additional guidance on
information to be provided by the medical
device manufacturer
Bibliography
Describes requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
| DevelopmentNote |
Supersedes AAMI ST81. (11/2017)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-685-6
|
| Pages |
37
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 17664:2017 | Identical |
| AAMI TIR16 : 2017 | MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO 25424:2009 | Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
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