Page 44 - Kit LUMIS CHU de RENNES Intervention le 16-03-2017

Instructions for Cleaning, Sterilization, Inspection and
®
Maintenance of SpineVision medical devices
English version

Application date : 2015-12-09 Reference document: CI_01EN

4. References

The reprocessing instructions have been written in accordance with standards:

- ISO 11607 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
- ISO 17664 - Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
- AAMI ST 79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- AAMI TIR 12 – Designing, testing and labelling reusable medical devices for reprocessing in Health Care
Facilities: A guide for medical device manufacturers.
- AAMI TIR 30 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning
reusable medical devices.
- Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labelling.
- ASTM F565 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- World Health Organization (WHO) and Robert Koch Institute (RKI) recommendations regarding exposure
time: WHO/CDS/CSR/APH/2000.3, Annex III, section 2, 6.

Refer to data on file for further information on the validation studies.

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