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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
15-01-2024
English
18-08-2017
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
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