PREN ISO 17664 : DRAFT 2001

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be provided by the manufacturer
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
Annex B (informative) An example of reprocessing
         instructions for reusable medical devices
         B.1 General
         B.2 Reprocessing instructions (reusable
             medical devices)
         Example template
Annex ZA (informative) Clauses of this European
          Standard addressing essential requirements
          or other provisions of EU Directives
Bibliography

Defines information to be provided by the manufacturer on the reprocessing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the user and requirements for validation of this information. It excludes textile devices used in patient draping systems or surgical clothing.