AAMI TIR14-2016
使用環(huán)氧乙烷進(jìn)行合同滅菌

Contract sterilization using ethylene oxide

適用范圍: This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.

術(shù)語(yǔ)	描述
方法適用性測(cè)試 method suitability test	使用選定的微生物進(jìn)行的測(cè)試，以證明存在或不存在抑制其繁殖的物質(zhì)
合同滅菌商 contract sterilizer	提供合同服務(wù)的設(shè)施，旨在滅菌由其他機(jī)構(gòu)制造的醫(yī)療器械
制造商 manufacturer	制造、加工或組裝完成設(shè)備的機(jī)構(gòu)，包括重新包裝或重新貼標(biāo)者
驗(yàn)證 verification	為確保系統(tǒng)當(dāng)前操作或適用性而進(jìn)行的評(píng)估
生物指示劑 biological indicators (BIs)	用于驗(yàn)證滅菌過(guò)程有效性的含有活微生物的測(cè)試系統(tǒng)