References - Stryker 0233032105 Manual Del Usuario

References

These processing instructions are provided in accordance with the below referenced
standards. While they have been validated by Stryker as being capable of preparing
the device for re-use, the end user is responsible for ensuring that the processing,
as actually performed (using equipment, materials, and personnel in the processing
facility), achieves the desired result. This normally requires routine monitoring and
validation of the facility's processing procedures. Stryker recommends users observe
these standards when processing medical devices.
1. AAMI TIR12: Design, testing and labeling reusable medical devices for processing in
healthcare facilities: a guide for medical device manufacturers
2. AAMI TIR30: A compendium of processes, materials, test methods, and acceptance
criteria for cleaning reusable medical devices
3. AAMI TIR34: Water for processing of medical devices
4. ANSI/AAMI ST58: Chemical sterilization and high-level disinfection in healthcare
facilities
5. ANSI/AAMI ST77: Containment devices for reusable medical device sterilization
6. ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility
assurance in healthcare facilities
7. ISO 15883-1: Washer-disinfectors — Part 1: General requirements, terms and
definitions and tests
8. ISO 17664: Sterilization of reusable instruments — Information to be provided by
the manufacturer for the processing of resterilizable reusable instruments
EN-16