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16/30280931 DC : DRAFT APR 2016

Superseded

Superseded

View Superseded by

BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES

Published date

05-10-2016

Superseded date

01-31-2018

Superseded by

BS EN ISO 17664:2004

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Summarise this standard

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) - An 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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on medical devices
Bibliography

BS EN ISO 17664.

Committee
²CH/198
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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