SAE AS21942 Body, Cluster Fitting, One Way, Flareless
作者:标准资料网 时间:2024-05-20 03:36:51 浏览:9726
来源:标准资料网
Product Code:SAE AS21942
Title:Body, Cluster Fitting, One Way, Flareless
Issuing Committee:G-3, Aerospace Couplings, Fittings, Hose, Tubing Assemblies
Scope:Scope unavailable.
【英文标准名称】:Asepticprocessingofhealthcareproducts-Part6:Isolatorsystems
【原文标准名称】:保健产品的无菌加工.第6部分:隔离器系统
【标准号】:ISO13408-6-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-06
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:无菌的;医疗卫生事业;无菌;证实;质量保证;清洁处理;绝缘子;医疗技术学;定义;规范(验收);隔离器
【英文主题词】:Aseptic;Cleaning;Definitions;Healthservices;Insulators;Isolators;Medicaltechnology;Qualityassurance;Specification(approval);Sterility;Validation
【摘要】:ThispartofISO13408specifiestherequirementsforisolatorsystemsusedforasepticprocessingandoffersguidanceonqualification,bio-decontamination,validation,operationandcontrolofisolatorsystemsusedforasepticprocessingofhealthcareproducts.ThispartofISO13408isfocusedontheuseofisolatorsystemstomaintainasepticconditions;thismayincludeapplicationsforhazardousmaterials.ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirementsthatpertaininparticulartonationalorregionaljurisdictions.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01
【页数】:17P;A4
【正文语种】:英语
