共找到 150 條與 滅菌保證水平 相關(guān)的標(biāo)準(zhǔn)，共 10 頁(yè)
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
This technical information report describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
This technical information report describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
本文件規(guī)定了對(duì)全部或部分來(lái)源于動(dòng)物材料的一次性使用醫(yī)療器械進(jìn)行滅菌的液體化學(xué)滅菌劑的特征，以及滅菌開(kāi)發(fā)、確認(rèn)、過(guò)程控制和監(jiān)控的要求。本文件適用于液體化學(xué)滅菌過(guò)程中細(xì)菌和真菌污染的風(fēng)險(xiǎn)控制，與其它微生物相關(guān)的風(fēng)險(xiǎn)可使用其他方法進(jìn)行評(píng)估。本文件不適用于：人體來(lái)源的材料；病毒和傳染性海綿狀腦?。═SE）滅
Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax
Steam Sterilization and Sterility Assurance in Healthcare Facilities
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
本標(biāo)準(zhǔn)規(guī)定了轄射滅菌使醫(yī)療保健產(chǎn)品達(dá)到10-6無(wú)菌保證水平的選定的滅菌劑量的證實(shí)和劑量審核方法。 本標(biāo)準(zhǔn)適用于整個(gè)產(chǎn)品單元的平均生物負(fù)載符合選定劑量所要求的平均生物負(fù)載范圍的醫(yī)療保健產(chǎn)品
Sterilization of health care products.Radiation.Substantiation of a selected sterilization dose method VDmax
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
This National Standard of Canada is equivalent to International Standard ISO 11137:1995. 1 Scope This International Standard specifies requirements
Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
This Technical Information Report is intended to prepare the industry for extending application of the VDmax method contained in ANSI/AAMI/ISO 11137-2
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
