KLS Martin group Instruments de chirurgie généraux Mode D'emploi page 32

In specific, the following sources should be observed for cleaning, instrument care, disinfection
and sterilization:
ISO 17664: "Sterilization of medical devices/Information to be provided by the
•
manufacturer for the processing of resterilizable medical devices"
• EN 285: "Sterilization – Steam sterilizers – Large sterilizers"
ISO 17665-1: Sterilization of health care products – Moist heat – Requirements for the
•
development, validation and routine control of a sterilization process for medical devices
EN 556-1: Sterilization of medical devices – Requirements for medical devices to be
•
designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices
Recommendation of the Instrument Preparation Working Group (Arbeitskreis
•
Instrumenten-Aufbereitung/AKI), http://www.a-k-i.org, "Proper Maintenance of
Instruments"
Recommendation of the German Society for Hospital Hygiene (Deutsche Gesellschaft für
•
Krankenhaushygiene/DGKH), http://www.dgkh.de, "Hygiene Requirements for
Reprocessing Medical Devices"
Recommendation of the Commission for Hospital Hygiene and Infection Prevention at the
•
Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices
(BfArM), http://www.rki.de, "Hygiene Requirements for Reprocessing Medical Devices"
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Instructions for Use
Surgical Instruments
Revision 5