I.S. EN ISO 17664-1:2021
Current
The latest, up-to-date edition.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semicritical medical devices (ISO 17664-1:2021)
Hardcopy , PDF
English
09-19-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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 device
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer
Bibliography
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