PREN ISO 17664 : DRAFT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
01-03-2004
12-01-2013
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
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