Tray, instrument

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
09-11-2017

제공처:

Oticon Medical A Division of Audmet Australia

수업:

Class I

Manufactured by:

Oticon Medical AB Datavagen 37B, Askim, SE-436 32 Sweden

치료 영역:

12143 - Tray, instrument

치료 징후:

The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use. The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles: Temperature 132?C (270?F) ? Exposure time 4 minutes minimum ? Dry for 20 minutes minimum. Temperature 134-137?C (273-278?F) ? Exposure time 3 minutes minimum ? Dry for 16 minutes minimum.

승인 상태:

A

승인 날짜:

2014-06-28

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