Exsurco Medical Amalgatome SD, Руководство пользователя

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A
MALGATOME
®
SD U
SER
G
UIDE
PN#: X101456, Rev. C Page 54 of 56
Appendix E: References for Sterilization
and Details of Validation Report
References
•
Current version of ANSI/AAMI/ISO 17665-1 – Sterilization of health care products – Moist heat – Part 1:
Requirements for the development, validation and routine control of sterilization process for medical
devices
•
Current version of AAMI TIR12 – Designing, testing and labeling reusable medical devices for
reprocessing in health care facilities: A guide for medical device manufacturers
•
Current version of ANSI/AAMI ST81 – Sterilization of medical devices – Information to be provided by
the manufacturer for the processing of resterilizable medical devices
•
Current version of ISO 17664 – Sterilization of medical devices – Information to be provided by the
manufacturer for the processing of resterilizable medical devices
•
Based on guidelines outlined in AAMI TIR12 – Designing, testing and labeling reusable medical devices
for reprocessing in health care facilities: A guide for medical device manufacturers
•
Current version of AAMI TIR30 – A compendium of processes, materials, test methods, and acceptance
criteria for cleaning reusable medical devices
•
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and
Radiological Health, and Office of Device Evaluations (March 17, 2015). Reprocessing Medical Devices
in Health Care Settings: Validation Methods and Labeling - Document Guidance for Industry and Food
and Drug Administration Staff
•
Current version of ANSI/AAMI ST8 – Hospital steam sterilizers
•
Current version of ANSI/AAMI ST79/A1/A2/ A3/A4 – Comprehensive guide to steam sterilization and
sterility assurance in health care facilities (Consolidated text)
Internal Validation Reports
•
Steam Sterilization Efficacy Validation of the Amalgatome
®
SD Reusable Surgical Device Report -
Project 154421.
•
Cleaning Efficacy Validation of the Amalgatome
®
SD Reusable Surgical Device and Sterilization Tray –
Manual Cleaning Report- Project 154421 Part I.
•
Cleaning Efficacy Validation of the Amalgatome
®
SD Reusable Surgical Device and Sterilization Tray –
Automated Cleaning Validation Summary Report- 165647
•
The cleaning agents listed below were used by Exsurco Medical when validating the instructions for
processing provided in this document.
•
Exsurco Medical does not recommend these products in preference to others that are available. Other
products may perform equally in conjunction with the equipment being used. The instructions provided
by the supplier of the detergents should be followed. Personal protection for operators should be
provided in accordance with the supplier´s instructions and safety data sheets. Suitability of alternative
agents should be checked by reference to the supplier’s information and/or physical testing.
Supplier Designation Comment
Steris Prolystica
®
2X Concentrate
Enzymatic Presoak
neutral pH or instrument safe enzymatic
cleaner