Standard No.:	GB 18281.1-2015
Chinese Name:	医疗保健产品灭菌 生物指示物 第1部分：通则
English Name:	Sterilization of health care products—Biological indicators—Part 1:General requirements
Professional Classification:	C47 Public medical equipment
Professional Classification:	GB National Standard
ICS Classification:	11.080.01 Sterilization and disinfection in general
Issued by:
Issued on:	2015-12-10
Implemented on:	2017-01-01
Status:	VALID
Replace:	GB18281.1-2000 Sterilization of health care products--Biological indicators--Part 1:General
Language:	English
File Format:	PDF
Word Count:	18000 words
Price(USD):	540 (USD)
Delivery:	via email in 1-5 business day

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
ISO8601 数据元和交换格式 信息交换 日期和时间表示法(Dataelementsandinterchange formats—Informationinterchange—Representationofdatesandtimes)
ISO11135-1 医疗保健产品灭菌 环氧乙烷 第1部分:医疗器械灭菌过程的开发、确认和常规控制的要求(Sterilizationofhealthcareproducts—Ethyleneoxide—Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO11135-2 医疗保健产品灭菌 环氧乙烷 第2部分:ISO11135-1应用指南(Sterilizationof
healthcareproducts—Ethyleneoxide—Part2:GuidanceontheapplicationofISO11135-1)
ISO11137-1 医疗保健产品灭菌 辐射 第1部分:医疗器械灭菌过程的开发、确认和常规控制要求(Sterilization ofhealth care products—Radiation—Part1:Requirementsfor development,validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO11137-2 医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量(Sterilizationofhealthcare
products—Radiation—Part2:Establishingthesterilizationdose)
ISO11137-3 医疗保健产品灭菌 辐射 第3部分:剂量测量指南(Sterilizationofhealthcareproducts—Radiation—Part3:Guidanceondosimetricaspects)
ISO11607-1 最终灭菌医疗器械的包装 第1部分:材料、无菌屏障系统和包装系统要求Packagingforterminallysterilizedmedicaldevices—
Part1:Requirementsformaterials,sterilebarriersystemsandpackagingsystems)
ISO11607-2 最终灭菌医疗器械的包装 第2部分:成形、密封和装配过程的确认(Packagingfor terminallysterilized medicaldevices—Part2:Validation requirementsforforming,sealing and
assemblyprocesses)