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EN ISO 17664:2004
Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Devices


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General Product Information

Document Type Standard
Status Current
Publisher:    Comite Europeen de Normalisation
Committee TC 204
Supersedes:
PREN ISO 17664:2001



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Table of Contents

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be provided by the medical device manufacturer
  3.1  Reprocessing instructions
  3.2  Limitations and restrictions on reprocessing
  3.3  Preparation at the point of use prior to processing
  3.4  Preparation before cleaning
  3.5  Cleaning
  3.6  Disinfection
  3.7  Drying
  3.8  Inspection, maintenance and testing
  3.9  Packaging
  3.10 Sterilization
  3.11 Storage
4 Presentation of the information
5 Validation of the reprocessing information provided
6 Risk analysis
Annex A (informative) Commonly utilized reprocessing methods
  A.1  General
  A.2  Matrix for identifying methods of processing
Annex B (informative) An example of reprocessing instructions
                      for reusable medical devices
Bibliography

Abstract

Describes the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.

History

2004 [01/03/2004]

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