NBN EN ISO 17664 : 2004
Current
The latest, up-to-date edition.
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
12-01-2013
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
Annex ZA (informative) Clauses of this European Standard addressing
essential requirements or other provisions of EU Directives
Bibliography
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