國際標準(ISO)
ISO 11135-1:2007 -醫療保健產品的消毒--環氧乙烷--第1部分：醫療設備消毒過程的制定、確認和常規控制的要求
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1:2006 -醫療保健產品的消毒--輻射--第1部分：醫療器件消毒過程的制定、確認、和常規控制的要求
Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-2:2013 -的醫療保健產品滅菌 - 輻射 - 第2部分：建立滅菌劑量
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization doseISO 11137-3:2006 -醫療保健產品的消毒--輻射--第3部分：劑量測定方面指南
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspectsISO 11138-1:2006 -醫療保健產品的消毒--生物指示劑--第1部分：一般要求
Sterilization of health care products -- Biological indicators -- Part 1: General requirementsISO 11138-2:2006 -醫療保健產品的消毒--生物指示劑--第2部分：環氧乙烷消毒同生物指示劑
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processesISO 11138-3:2006 -醫療保健產品的消毒--生物指示劑--第3部分：濕熱消毒用生物指示劑
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processesISO 11138-4:2006 -醫療保健產品的消毒--生物指示劑--第4部分：幹熱消毒處理用生物指示器
Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processesISO 11138-5:2006 -醫療保健產品的消毒--生物指示劑--第5部分：低溫蒸汽和甲醛溶液消毒處理用生物指示器
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesISO 11140-1:2005 -醫療保健產品的消毒--化學指示劑--第1部分：一般要求
Sterilization of health care products -- Chemical indicators -- Part 1: General requirementsISO 11140-3:2007 -醫療保健產品的消毒--化學指示劑--第3部分：布維-狄克(Bowie and Dick-type)蒸汽穿透測試用2級指示劑體系
Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration testISO 11140-4:2007 -醫療保健產品的消毒--化學指示劑--第4部分：蒸汽穿透檢測布維-狄(Bowie and Dick)形式測試的2級指示劑
Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetrationISO 11140-5:2007 -醫療保健產品的消毒--化學指示劑--第5部分：布維-狄克形式(Bowie and Dick-type)除氣測試的2級指示劑
Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal testsISO 11607-1:2006 -終端無菌醫學設備的包裝--第1部分：原材料、消毒阻擋系統和包裝的要求
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2:2006 -終端無菌醫學設備的包裝--第2部分：組成、密封和裝配過程的確認要求
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processesISO 11737-1:2006 -醫療器械消毒--微生物學方法--第1部分：產品上微生物群落的測定
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on productsISO 11737-2:2009 -醫療器械消毒--微生物學方法--第2部分：不孕進行測試中消毒處理的定義、確認與維護
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processISO 13408-1:2008 -醫療保健產品的無菌加工--第1部分：一般要求
Aseptic processing of health care products -- Part 1: General requirementsISO 13408-2:2003 -醫療保健產品的無菌加工--第2部分：過濾
Aseptic processing of health care products -- Part 2: FiltrationISO 13408-3:2006 -醫療保健產品的無菌加工--第3部分：凍幹法
Aseptic processing of health care products -- Part 3: LyophilizationISO 13408-4:2005 -醫療保健產品的無菌加工--第4部分：就地清洗技術
Aseptic processing of health care products -- Part 4: Clean-in-place technologiesISO 13408-5:2006 -醫療保健產品的無菌加工--第5部分：現場消毒
Aseptic processing of health care products -- Part 5: Sterilization in placeISO 13408-6:2005 -醫療保健產品的無菌加工--第6部分：隔離器系統
Aseptic processing of health care products -- Part 6: Isolator systemsISO 13408-7:2012 -醫療器械和組合產品的替代方法：第7部分 - 保健產品的無菌加工
Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination productsISO 14160:2011 -醫療保健產品滅菌 - 化學液體的滅菌用動物組織及其衍生物一次性使用的醫療器械代理 - 為表徵，開發，驗證和滅菌過程的醫療設備常規控制的要求
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesISO 14161:2009 -醫療保健產品的消毒--生物指示劑--選擇、使用和解釋結果的指南
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of resultsISO 14937:2009 -醫療保健產品的消毒--消毒劑特徵的一般要求與醫療設備消毒過程的開發、驗證和常規控制
Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 15882:2008 -醫療保健產品的消毒--化學指示劑--選擇、使用和結果說明用指南
Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of resultsISO 15883-1:2006 -洗滌消毒器--第1部分：一般要求、術語、定義和測試
Washer-disinfectors -- Part 1: General requirements, terms and definitions and testsISO 15883-2:2006 -洗滌消毒器--第2部分：對外科設備、麻醉設備、碗、碟、收集器、器皿、玻璃器具等進行熱消毒的洗滌消毒器的要求和測試
Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.ISO 15883-3:2006 -洗滌消毒器--第3部分：對人類廢棄物容器進行熱消毒的洗滌消毒器的要求和測試
Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containersISO 15883-4:2008 -洗滌消毒器--第4部分：不耐熱的內診鏡使用化學消毒的墊圈-消毒器具的要求和測試
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesISO 15883-6:2011 -清洗消毒 - 第6部分：要求和試驗清洗消毒採用熱消毒的非侵入性，非關鍵的醫療設備和醫療設備
Washer-disinfectors -- Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipmentISO 17664:2004 -醫療設備的消毒--生產商提供的可重複消毒醫療器械的處理資訊
Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devicesISO 17665-1:2006 -醫療保健產品的消毒--濕熱--第1部分：醫療機械消毒過程的制定、確認和常規控制的要求
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 18472:2006 -醫療保健產品的消毒--生物和化學指示劑--測試器械
Sterilization of health care products -- Biological and chemical indicators -- Test equipmentISO 20857:2010 -醫療保健產品的消毒--乾熱--醫療設備消毒過程的開發、驗證和常規控制
Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 25424:2009 -醫療設備的消毒--低溫蒸汽與甲醛--醫療設備消毒過程的開發、驗證和常規控制
Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devicesISO/AWI 17210 -測試方法展示出一種醫療設備模擬器的過程中蒸汽消毒的適宜性 - 醫療設備模擬器測試
Test method to demonstrate the suitability of a medical device simulator during steam sterilization -- Medical device simulator testingISO/CD 11137-3 -醫療保健產品滅菌 - 輻射 - 第3部分：指導劑量學方面
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspectsISO/CD 18362 -細胞為基礎的保健品加工
Processing of cell-based health care productsISO/DIS 11135.2 -環氧乙烷 - - 對滅菌過程對醫療器械的開發，驗證和常規控制要求的醫療保健產品滅菌
Sterilization of health-care products -- Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devicesISO/DIS 11140-1 -一般要求： - 化學指示物 - 第1部分的醫療保健產品滅菌
Sterilization of health care products -- Chemical indicators -- Part 1: General requirementsISO/NP 11138-6 -生物指標過氧化氫蒸汽滅菌過程： - 生物指標 - 第6部分的醫療保健產品滅菌
Sterilization of health care products -- Biological Indicators -- Part 6: Biological indicators for hydrogen peroxide vapour sterilization processesISO/NP 11140-6 -2級指標和蒸汽滅菌器的性能測試使用過程中的挑戰裝置： - 化學指示物 - 第6部分的醫療保健產品滅菌
Sterilization of health care products -- Chemical indicators -- Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizersISO/PRF TS 16775 -包裝為最終滅菌醫療器械 - 指導ISO11607-1和ISO11607-的應用
Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2ISO/TS 11135-2:2008 -醫療保健產品的消毒--環氧乙烷--第2部分：ISO 11135-1應用指南
Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1ISO/TS 11139:2006 -醫療保健產品的消毒--詞彙
Sterilization of health care products -- VocabularyISO/TS 13004:2013 -醫療保健產品滅菌 - 輻射 - 屬實選擇的滅菌劑量的方法：方法VDmaxSD
Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSDISO/TS 15883-5:2005 -洗滌消毒器--第5部分：測試土和清潔效果的實驗說明方法
Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacyISO/TS 17665-2:2009 -醫療保健產品的消毒--濕熱--第2部分：ISO 17665-1的應用指南
Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1ISO/TS 17665-3:2013 -醫療保健產品滅菌 - 濕熱 - 第3部分：指導醫療器械的產品系列及加工類蒸汽消毒的指定
Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilizationISO/WD 15883-4 -清洗消毒 - 第4部分：要求和試驗清洗消毒採用化學消毒不耐熱內窺鏡
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesISO/WD 15883-7 -清洗消毒 - 第7部分：要求和試驗清洗消毒採用化學消毒的非侵入性，非關鍵不耐熱的醫療設備和醫療設備
Washer-disinfectors -- Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment