ANSI/AAMI/ISO 17664:2017
Superseded
View Superseded by
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Superseded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 |
A newer version of this standard is available.
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