BS EN 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
01-09-2021
English
08-01-2018
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
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