CSA Z17664 : 2006 (R2016)
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
Hardcopy , PDF
19-11-2018
English
01-01-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be provided by the medical device manufacturer
4 Presentation of the information
5 Validation of the reprocessing information provided
6 Risk analysis
Annex A (informative) - Commonly utilized reprocessing methods
Annex B (informative) - An example of reprocessing instructions
for reusable medical devices
Bibliography
Gives 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.
| DocumentType |
Standard
|
| Pages |
32
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 17664:2017 | Identical |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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