01/561624 DC : DRAFT APR 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 17664 STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
12-03-2004
23-11-2012
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
BS EN ISO 17664
| Committee |
CH/67
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 17664 : DRAFT 2001 | Identical |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
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