當前，一場防控新型冠狀病毒肺炎的全民阻擊戰已經打響，全國上下眾志成城，共克時艱。本文將口罩、消毒劑、手套、護目鏡、防護服等防護產品相關國內外標準進行整理匯編，供參考。篇幅較長，建議收藏。 第一部分 口罩相關國內外標準 國別 標準號 中文題名 英文題名 中國 GB 2626-2006 呼吸防護用品 自吸過濾式防顆粒物呼吸器 Respiratory protective equipment. Non-powered air-purifying particle respirator GB 2626-2019 呼吸防護 自吸過濾式防顆粒物呼吸器 GB/T 18664-2002 呼吸防護用品的選擇、使用與維護 Selection,use and maintenance of respiratory protective equipment GB 19083-2010 醫用防護口罩技術要求 Technical requirements for protective face mask for medical use GB/T 23465-2009 呼吸防護用品 實用性能評價 GB/T 32610-2016 日常防護型口罩技術規范 Technical specification of daily protective mask YY 0469-2011 醫用外科口罩 Surgical mask YY/T 0691-2008 傳染性病原體防護裝備 醫用面罩抗合成血穿透性試驗方法(固定體積、水平注射) Clothing for protection against infectious agents. Medical face masks. Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) YY/T 0866-2011 醫用防護口罩總泄漏率測試方法 Total inward leakage determination method of protective face mask for medical use YY/T 0969-2013 一次性使用醫用口罩 Single-use medical face mask YY/T 1497-2016 醫用防護口罩材料病毒過濾效率評價測試方法 Phi-X174噬菌體測試方法 Evaluation test method for the viral filtration efficiency (VFE)of medical protective face mask materials. Test method using Phi-X174 bacteriophage DB 50/ 107-2003 醫用紗布口罩 DB 62/T 518-1998 一次性使用無紡布系列醫療衛生用品 DB 65/T 2028-2003 醫用脫脂紗布口罩 Medical purified ganuze mask CNS 14258-1998 呼吸防護具之選擇、使用及維護方法 Guidance for seclection use and maintenance of respiratory protective devices CNS 14755-2003 拋棄式防塵口罩 Disposable dust respirators CNS 14756-2003 附加活性碳拋棄式防塵口罩 Disposable dust respirators with activated - carbon CNS 14774-2018 醫用面(口)罩 Medical face masks CNS 14775-2003 醫用面罩材料細菌過濾效率試驗法─使用金黃色葡萄球菌生物氣霧 Method of test for evaluating the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of staphylococcus aureus CNS 14776-2003 醫用面罩對合成血液穿透阻力的試驗法─以已知速度定量的水平噴灑 Method of test for resistance of medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity) CNS 14777-2003 醫用面罩空氣交換壓力之試驗法 Method of test for air exchange pressure of medical face mask CNS 16076-2018 呼吸防護裝置－全面罩－要求、試驗、標示 Respiratory protective devices. Full face masks. Requirements, testing, marking 國際 ISO 22609-2004 傳染試劑防護服.醫療面罩.防人造血滲透的試驗方法(固定容積,水平注射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) 歐洲 EN 136-1998+AC-2003 呼吸保護裝置 全面罩 要求、測試和標記 Respiratory protective devices. Full face masks. Requirements,testing,marking EN 140-1998+AC-1999 呼吸保護裝置 半面罩和1/4面罩式 要求、測試和標記 Respiratory protective devices. Half masks and quarter masks. Requirements,testing,marking EN 143-2000 呼吸保護裝置 - 粒子濾波 - 要求、測試、標識 Respiratory protective devices. Particle filters. Requirements,testing,marking Including corrigenda July 2002 and March 2005;Including Amendment A1:June 2006 EN 149-2001 呼吸防護裝置.顆粒防護用過濾半面罩.要求、檢驗和標記 Respiratory protective devices - Filtering half masks to protect against particles - Requirements testing marking EN 149-2001+A1-2009 呼吸保護裝置 顆粒防護用過濾半遮罩 要求、測試和標記 Respiratory protective devices. Filtering half masks to protect against particles. Requirements,testing,marking EN 529-2005 呼吸保護器 選擇、使用、維護和保養建議 指導性文件 Respiratory protective devices. Recommendations for selection,use,care and maintenance. Guidance document Supersedes CR 529:1993 EN 12942-1998+A2-2008 呼吸保護裝置 全面罩、半面罩或1/4面罩式動力過濾裝置 要求、測試和標記 Respiratory protective devices. Power assisted filtering devices incorporating full face masks,half masks or quarter masks. Requirements,testing,marking EN 14387-2004+A1-2008 呼吸保護裝置 氣體過濾器和組合過濾器 要求、測試和標記 Respiratory protective devices. Gas filter(s) and combined filter(s). Requirements,testing,marking EN 14683-2019+AC-2019 醫用口罩 要求和試驗方法 Medical face masks - Requirements and test methods 美國 ASTM F1862/F1862M-2017 醫用口罩抗人工合成血滲透的標準試驗方法(已知速度下固定體積的水平投影) Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) ASTM F2100-2019 醫用口罩材料性能標準規范 Standard Specification for Performance of Materials Used in Medical Face Masks ASTM F2101-2019 用金黃色葡萄球菌生物氣溶膠評價醫用口罩材料的細菌過濾效率(BFE)的標準試驗方法 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus ASTM F2299/F2299M-2003(2017) 用乳膠球測定醫用口罩材料被微粒滲透的初始效率的標準試驗方法 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres CFR 42-84-1995解釋指南 NIOSH顆粒物防護口罩的選擇和使用指南 NIOSH Guide to the Selection and Use of Particulate Respirators 英國 BS EN 136-1998 呼吸保護裝置.全面罩.要求、試驗、標記 Respiratory protective devices. Full face masks. Requirements,testing,marking BS EN 140-1999 呼吸保護裝置 半口罩和四分之一口罩 要求、試驗、標記 Respiratory protective devices. Half masks and quarter masks. Requirements,testing,marking BS EN 143-2000 呼吸防護裝置 微粒過濾器 要求、測試、標記 Respiratory protective devices. Particle filters. Requirements,testing,marking BS EN 149-2001+A1-2009 呼吸保護裝置 可防微粒的過濾式半面罩 要求、試驗、標記 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking BS EN 529-2005 呼吸保護裝置 選擇、使用、保養和維護的建議 指導文檔 Respiratory protective devices. Recommendations for selection,use,care and maintenance. Guidance document BS EN 14387-2004+A1-2008 呼吸防護裝置 氣體過濾器和組合過濾器 要求、試驗、標志 Respiratory protective devices. Gas filter(s) and combined filter(s). Requirements, testing, marking BS EN 14683-2019 醫用口罩 要求和試驗方法 Medical face masks. Requirements and test methods 德國 DIN EN 136-1998 呼吸保護器.全面罩.要求、檢驗、標志 Respiratory protective devices. Fullface masks. Requirements, testing, marking; German version EN136:1997 DIN EN 140-1998 呼吸保護器.半面和四分之一面罩.要求、檢驗、標記 Respiratory protective devices. Half masks and quarter-masks. Requirements, testing, marking; German version EN140:1998 DIN EN 149-2009 呼吸保護裝置 過濾半面罩以防止顆粒物 要求，測試，標記; Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking; German version EN149:2001+A1:2009 DIN EN 529-2006 呼吸保護器 選擇、使用、維護和保養建議 指導性文件 Respiratory protective devices. Recommendations for selection, use, care and maintenance. Guidance document; German version EN529:2005 DIN EN 14683-2019 醫用口罩 要求和試驗方法 Medical face masks - Requirements and test methods; German version EN 14683:2019+AC:2019 法國 NF S76-014-2009 呼吸保護裝置.顆粒防護用過濾式半面罩.要求、試驗、標記 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking NF S76-034-1998 呼吸保護裝置與防護罩或防護面具結合的帶動力粒子過濾裝置.要求,試驗, 標志 Respiratory protective devices. Powered filtering devices incorporating a helmet or a hood. Requirements, testing, marking. NF S97-166-2014 醫用口罩 要求和試驗方法 Medical face masks - Requirements and test methods NF EN 140-1998 呼吸保護裝置.1/2 和1/4 防毒面具.要求,試驗和標志 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking NF EN 12941-1998 呼吸保護裝置與防護罩或防護面具結合的帶動力粒子過濾裝置.要求,試驗, 標志 Respiratory protective devices. Powered filtering devices incorporating a helmet or a hood. Requirements, testing, marking. 澳大利亞 AS/NZS 1715-2009 呼吸保護設備的選擇 使用和維護 Selection, Use And Maintenance Of Respiratory Protective Equipment AS/NZS 1716-2012 呼吸防護設備 Respiratory protective devices 日本 JIS T8062-2010 預防傳染性病原體的防護服.面罩.防止人造血漿滲透的試驗方法(確定容量,水平注射) Clothing for protection against infectious agents -- Face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) JIS T8150-2006 呼吸防護器具的選擇、使用及保管辦法 Guidance for selection, use and maintenance of respiratory protective devices JIS T8159-2006 呼吸防護面具漏泄率試驗方法 Leakage rate testing method for respiratory protective devices 韓國 KS M 6673-2008 防塵口罩 Dust respirators KS K ISO 22609-2018 抗傳染病防護服 醫用口罩 合成血液抗滲透的試驗方法(確定容量,水平注射) Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood(fixed volume, horizontally projected) 越南 TCVN 8389-1-2010 醫用口罩. 第1部分: 普通醫用口罩 Medical face mask. Part 1: Normal medical face mask. TCVN 8389-2-2010 醫療口罩. 第2部分: 防細菌醫用口罩 Medical face mask. Part 2: Medical face mask preventing bacteria. TCVN 8389-3-2010 醫用口罩. 第3部分: 防有毒化學物質醫用口罩 Medical face mask. Part 3: Medical face mask preventing of toxic chemicals 其他國家 DS/ISO 22609-2005 防病毒衣物. 醫用口罩. 合成血液滲透性測試方法(確定容量,水平注射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) GOST 12.4.166-2018 職業安全標準體系 呼吸保護裝置 面具 一般規范 Occupational Safety Standards System. Respiratory Protective Devices. Facepiece. General Specifications GOST 12.4.285-2015 職業安全標準體系 呼吸保護裝置 防微粒過濾半面罩 一般規范 Occupational safety standards system. Respiratory protective devices. Filter self-rescuer. General technical requirements. Test methods GOST 12.4.294-2015 職業安全標準體系 呼吸保護裝置 面罩 一般規范 Occupational safety standards system. Respiratory protective devices. Filtering half masks to protect against particles. General specifications GOST R 58396-2019 醫療口罩 要求和測試方法 Medical Face Masks. Requirements And Test Methods AS/NZS 1715-2009 呼吸保護設備的選擇 使用和維護 Selection, Use And Maintenance Of Respiratory Protective Equipment AS/NZS 1716-2012 呼吸防護設備 Respiratory protective devices SANS 1866-1-2018 醫療設備 第1部分 醫用口罩 Medical devices Part 1: Medical face masks SANS 50136-1998 呼吸保護裝置. 全面罩. 要求、測試、標記 Respiratory Protective Devices. Full Face Masks. Requirements, Testing, Marking SANS 50140-1998 呼吸保護裝置. 半面罩和四分之一面罩. 要求、測試、標記 Respiratory Protective Devices. Half Masks And Quarter Masks. Requirements, Testing, Marking SS 548-2009 選擇、使用和維修呼吸保護裝置 Code of practice for selection, use and maintenance of respiratory protective devices ABNT NBR 13694-1996 呼吸保護裝置 半面罩和四分之一面罩 規范 Respiratory protective devices. Half masks and quarter masks. Specification ABNT NBR 13695-1996 呼吸保護裝置 全面罩 規范 Respiratory protective devices. Full face masks. Specification ABNT NBR 13698-2011 呼吸保護裝置 顆粒過濾半面罩 Respiratory protective devices. Filtering half mask to protect against particles IS 14166-1994 呼吸防護裝置：全面罩 Respiratory protective devices : Full face masks IS 14746-1999 呼吸防護裝置-半面罩和四分之一面罩 Respiratory Protective Devices - Half Masks And Quarter Masks IS 9473-2002 呼吸防護裝置-防止顆粒的過濾半面罩 Respiratory Protective Devices - Filtering Half Masks to Protect Against Particles UNI EN 14683-2019 醫用口罩 要求和試驗方法 Medical face masks - Requirements and test methods IS 9623-2008 呼吸防護裝置的選擇、使用和維護-規程 Selection, use and maintenance of respiratory protective devices - Code of practice UNE EN 14683-2014 醫用口罩 要求和試驗方法 Medical Face Masks - Requirements And Test Methods 第二部分 消毒劑相關國內外標準 類別 標準號 中文題名 英文題名 中國 GB/T 10666-2019 次氯酸鈣（漂粉精） Calcium hypochlorite GB 16383-2014 醫療衛生用品輻射滅菌消毒質量控制 Quality control for radiation sterilization of medical and hygienical products GB 18280-2000 醫療保健產品滅菌 確認和常規控制要求 輻射滅菌 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization GB/T 19104-2008 過氧乙酸溶液 Peracetic acid solution GB/T 19106-2013 次氯酸鈉 Sodium hypochlorite GB 19193-2015 疫源地消毒總則 General principle on disinfection for infectious focus GB/T 19633-2005 最終滅菌醫療器械的包裝 Packaging for terminally sterilized medical devices GB/T 20468-2006 臨床實驗室定量測定室內質量控制指南 Guideline for internal quality control for quantitative measurements in clinical laboratory GB/T 20469-2006 臨床實驗室設計總則 General guideline of the clinical laboratory design GB/T 20470-2006 臨床實驗室室間質量評價要求 Requirements of external quality assessment for clinical laboratories GB/T 23854-2009 溴氯海因 Bromochloro-5,5-dimethylhydantoin GB/T 23854-2019 溴氯海因 Bromochloro-5,5-dimethylhydantoin GB/T 26366-2010 二氧化氯消毒劑衛生標準 Hygienic standard for chlorine dioxide disinfectant GB/T 26367-2010 胍類消毒劑衛生標準 Hygienic standard for biguanides disinfectants GB/T 26368-2010 含碘消毒劑衛生標準 Hygienic standard for iodine disinfectants GB/T 26369-2010 季銨鹽類消毒劑衛生標準 Hygienic standard for quaternary ammonium disinfectant GB/T 26370-2010 含溴消毒劑衛生標準 Hygienic standard for disinfectants with bromine GB/T 26371-2010 過氧化物類消毒劑衛生標準 Hygienic standard for peroxide disinfectants GB/T 26372-2010 戊二醛消毒劑衛生標準 Hygienic standard for glutaraldehyde disinfectant GB/T 26373-2010 乙醇消毒劑衛生標準 Hygienic standard for alcohol disinfectants GB/T 27947-2011 酚類消毒劑衛生要求 Hygienic requirements for phenol disinfectant GB 27948-2011 空氣消毒劑衛生要求 Hygienic requirements for air disinfectant GB/T 27949-2011 醫療器械消毒劑衛生要求 Hygienic requirements for medical items disinfection GB 27950-2011 手消毒劑衛生要求 Hygienic requirements for hand antiseptic agents GB 27951-2011 皮膚消毒劑衛生要求 Hygiene requirements for skin disinfectant GB 27952-2011 普通物體表面消毒劑的衛生要求 Hygienic requirements for surface disinfectants GB 27953-2011 疫源地消毒劑衛生要求 Hygienic requirements of disinfectant for infectious focus GB 27954-2011 黏膜消毒劑通用要求 General standard for disinfectant of mucous membrane GB 27955-2011 過氧化氫氣體等離子體低溫滅菌裝置的通用要求 General requirements for low-temperature hydrogen peroxide gas plasma sterilizer GB 28232-2011 臭氧發生器安全與衛生標準 Safety and sanitation standard for ozone generator GB 28233-2011 次氯酸鈉發生器安全與衛生標準 Safety and hygienic standard for disinfection by sodium hypochlorite generator GB 28234-2011 酸性氧化電位水生成器安全與衛生標準 Safety and sanitation standard for acidic electrolyzed-oxidizing water generator GB 28235-2011 紫外線空氣消毒器安全與衛生標準 Safety and sanitary standard for ultraviolet appliance for air disinfection GB 28931-2012 二氧化氯消毒劑發生器安全與衛生標準 Safety and sanitation standard for chlorine dioxide disinfectant generator GB/T 30224-2013 剛地弓形蟲試驗臨床應用 Clinical use of tests for Toxoplasma gondii GB 30689-2014 內鏡自動清洗消毒機衛生要求 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes GB/T 30690-2014 小型壓力蒸汽滅菌器滅菌效果監測方法和評價要求 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer GB/T 33417-2016 過氧化氫氣體滅菌生物指示物檢驗方法 Test method of biological indicator for hydrogen peroxide vapour sterilization processes GB/T 33418-2016 環氧乙烷滅菌化學指示物檢驗方法 Test method of chemical indicator for ethylene oxide sterilization processes GB/T 33419-2016 環氧乙烷滅菌生物指示物檢驗方法 Test method of biological indicator for ethylene oxide sterilization processes GB/T 33420-2016 壓力蒸汽滅菌生物指示物檢驗方法 Evaluation standard of biological for moist heat sterilization processes GB/T 36758-2018 含氯消毒劑衛生要求 Hygienic requirements for disinfectants with chlorine YY/T 0215-2016 醫用臭氧消毒設備 Ozone disinfector for medical purpose YY 0970-2013 含動物源材料的一次性使用醫療器械的滅菌液體滅菌劑滅菌的確認與常規控制 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants WS/T 327-2011 消毒劑殺滅分枝桿菌實驗評價要求 Requirements of mycobactericidal evaluation for disinfectant in laboratory WS/T 466-2014 消毒專業名詞術語 Disinfection professional terms WS/T 496-2017 臨床實驗室質量指標 Quality indicators in clinical laboratories WS/T 497-2017 侵襲性真菌病臨床實驗室診斷操作指南 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases WS/T 498-2017 細菌性腹瀉臨床實驗室診斷操作指南 Performance guideline for clinical laboratory diagnosis of bacterial diarrhea WS/T 508-2016 醫院醫用織物洗滌消毒技術規范 Regulation for washing and disinfection technique of medical textiles in healthcare facilities WS/T 514-2017 臨床檢驗方法檢出能力的確立和驗證 Establishment and verification of detection capability for clinical laboratory measurement procedures WS 628-2018 消毒產品衛生安全評價技術要求 WS/T 646-2019 過碳酸鈉消毒劑衛生要求 WS/T 648-2019 空氣消毒機通用衛生要求 GA/T 933-2011 生物樣品中氟乙酸根離子的氣相色譜和氣相色譜-質譜聯用檢驗方法 GC and GC-MS examination methods for monofluorocetate anion in biological samples GA/T 934-2011 生物樣品中次烏頭堿、烏頭堿、中烏頭堿的液相色譜-串聯質譜檢驗方法 SN/T 1823-2006 醫學媒介生物衛生處理常用藥物及處理方法 Common drugs and methods of sanitary treatment for medical vectors SN/T 2064-2008 國際直達列車突發公共衛生事件處理規程 Codes for the rapid response to the public health emergency occurred in international trains SN/T 2069-2008 國際旅行衛生保健中心 質量管理標準及評價 Quanlity management criterion and evaluation of international travel healthcare centre SN/T 4387-2015 進出口一次性使用衛生用品檢驗規程 Rules for inspection of disposable sanitary products for import and export DB11/ 116-1999 送餐企業衛生規范 DB65/T 2176-2004 高原地區醫療機構消毒滅菌工作規程 Rules of Disinfecting Sterilization in Medical Institute on Plateau DB65/T 2203-2005 海拔2000m以上地區壓力蒸汽滅菌效果評價方法與標準 Methods and Standards to Evaluting the Efficacy of High.pressure Steam Sterilization at Altitude Above 2000m DB13/T 491-2003 有害生物防制服務質量要求 DB31/ 405-2008 公共場所空調通風系統運行衛生要求 DB31/ 358-2006 驅避劑衛生安全要求 DB31/ 354-2005 消毒劑生產環境衛生要求 DB31/ 486-2010 獻血屋(點)安全衛生要求 Requirements for Fixed Collection Sites DB31/T 794-2014 老年護理院分級護理要求 Requirments of grading nursing in Geriatric Nursing Hospital DB34/T 1352-2011 住宿業衛生服務規范 Hygienic Service Specification for Lodging Industry DB44/T 951-2011 水產品加工過程臭氧及過氧化氫使用準則 Guidelines for the use of ozone and hydrogen peroxide in fishery products CNS 5937-1980 滅菌盤（消毒盤） Sterilizing Trays CNS 14622-1-2002 保健產品之滅菌─生物指示劑─第一部份：通則 Sterilization of health care products-biological indicators-part 1：General CNS 14622-2-2002 保健產品之滅菌─生物指示劑─第二部分：使用環氧乙烷滅菌的生物指示劑 Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization CNS 14622-3-2002 保健產品之滅菌─生物指示劑─第三部分：用于濕熱滅菌的生物指示劑 Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization CNS 14623-1-2002 保健產品之滅菌─化學指示劑─第一部分：一般規定 Sterilization of health care products-chemical indicators-Part 1：General requirements CNS 14708-2002 醫療器材－環氧乙烷滅菌確效與例行管制 Medical decice-validation and routine control of ethylene oxide strilization CNS 14709-2002 保健產品之滅菌－輻射滅菌確效與例行管制規定 Sterilization of health care products-requirements for validation and routine control-radiation sterliization 國際 ISO 6579 CORR 1-2004 食品和動物飼料的微生物學.沙門氏菌屬檢測的水平法.技術勘誤1 Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp,; Technical Corrigendum 1 ISO 11140-1:2014 保健品消毒. 化學指示物. 通用要求 Sterilization of health care products — Chemical indicators — Part 1: General requirements ISO 11140-3-2007 衛生保健品的滅菌.化學指示劑.第3部分:布維-狄克(Bowie and Dick-type)蒸汽穿透試驗用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 test ISO 11140-4-2007 衛生保健品的滅菌.化學指示劑.第4部分:蒸汽穿透檢測布維-狄(Bowie and Dick)形式試驗的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 penetration ISO 11140-5-2007 衛生保健品的滅菌.化學指示劑.第5部分:布維-狄克形式(Bowie and Dick-type)除氣試驗的2級指示劑 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests ISO 11607-1:2019 最終滅菌醫療器械的包裝. 第1部分：材料、無菌屏障系統和包裝系統的要求 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 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 requirements ISO 13408-2-2018 醫療保健產品的無菌加工.第2部分:除菌過濾 Aseptic processing of health care products - Part 2: Sterilizing filtration ISO 13408-3-2006 衛生保健產品的無菌工藝.第3部分:凍干法 Aseptic processing of health care products - Part 3: Lyophilization ISO 13408-6-2005 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 systems ISO 18472:2018 保健品消毒. 化學指示物. 試驗設備 Sterilization of health care products — Biological and chemical indicators — Test equipment CIE 155-2003 紫外線空氣消毒法 ULTRAVIOLET AIR DISINFECTION (G) 歐洲 EN 1499-2013 化學消毒劑和防腐劑.消毒洗手液.檢驗方法和要求(第2階段/2級) Chemical Disinfectants and Antiseptics - Hygienic Handwash - Test Method and Requirements (Phase 2/Step 2) EN 1811:2011+A1:2015 從插入人體穿孔部分和與皮膚直接和長期接觸的物品的所有柱組件中釋放鎳的參考試驗方法 Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin 美國 ANSI/AAMI/ISO 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: Filtration ANSI/AAMI/ISO 13408-3-2006 衛生保健產品的無菌工藝.第3部分:凍干法 Aseptic Processing of health care products - Part 3: Lyophilization ANSI/AAMI/ISO 13408-4-2005 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 technologies ANSI/AAMI/ISO 13408-5-2006 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 place ANSI/AAMI/ISO 13408-6-2005 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 systems ANSI/AAMI/ISO 13408-6/A1-2013 保健產品的防腐處理.第6部分:隔離器.修改件1 Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1 ANSI/AAMI/ISO 13408-7-2012 保健產品的無菌加工.第7部分:非典型醫療設備和組合產品用替換加工 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products ANSI/AAMI ST79/A 3.1-2012 衛生醫療設施蒸汽滅菌法和無菌保證綜合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.3-2012 衛生醫療設施蒸汽滅菌法和無菌保證綜合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.4-2012 衛生醫療設施蒸汽滅菌法和無菌保證綜合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.6-2012 衛生醫療設施蒸汽滅菌法和無菌保證綜合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.7-2012 衛生醫療設施蒸汽滅菌法和無菌保證綜合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/American Society of Sanitary Engineering SERIES 12000-2018 所有建筑系統感染控制風險評估專業資格標準 Professional Qualifications Standard for Infection Control Risk Assessment for All Building Systems ANSI/ASTM E2553-2007 自動通用衛生保健識別系統實施用指南 Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System ANSI/MEDBIQ PP.10.1-2008 衛生保健專業簡介 Healthcare Professional Profile ANSI/NSF 49(i14)-2008 II級(層流)生物安全室 Class II (laminar flow) biosafety cabinetry ANSI/NSF 49(i15r2)-2008 生物安全柜:設計,制作,性能和行業認證 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification ANSI/NSF 49(i27)-2011 生物安全柜:設計,制作,性能和行業認證 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ANSI/NSF 49(i42)-2011 生物安全柜:設計,制作,性能和行業認證 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ANSI/NSF 49(i43)-2011 生物安全廚柜:設計,建造,性能和實地認證 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ASHRAE QC-06-066-2006 在飛機艙實體模擬的空降疾病傳播的示蹤研究 Tracer Study of Airborne Disease Transmission in an Aircraft Canin Mock-Up CFR 42-70.1-2017 公共衛生.第70部分：州際隔離.第70.1節：一般定義. Public health. Part 70: Interstate quarantine. Section 70.1: General definitions. CFR 42-70.5-2017 公共衛生.第70部分：州際隔離.第70.5節：與聯邦隔離、隔離或有條件釋放令下的旅行者有關的要求. Public health. Part 70: Interstate quarantine. Section 70.5: Requirements relating to travelers under a Federal order of isolation, quarantine, or conditional release. CFR 42-70.6-2017 公共衛生.第70部分：州際隔離.第70.6節：逮捕和拘留患有可隔離傳染病的人. Public health. Part 70: Interstate quarantine. Section 70.6: Apprehension and detention of persons with quarantinable communicable diseases. CFR 42-70.10-2017 公共衛生.第70部分：州際隔離.第70.10節：公共衛生預防措施，以發現傳染病. Public health. Part 70: Interstate quarantine. Section 70.10: Public health prevention measures to detect communicable disease. CFR 42-70.11-2017 公共衛生.第70部分：州際隔離.第70.11節：航空公司經營的飛機上死亡或生病的報告. Public health. Part 70: Interstate quarantine. Section 70.11: Report of death or illness onboard aircraft operated by an airline. CFR 42-70.12-2017 公共衛生.第70部分：州際隔離.第70.12節：體檢. Public health. Part 70: Interstate quarantine. Section 70.12: Medical examinations. CFR 42-70.13-2017 公共衛生.第70部分：州際隔離.第70.13節：支付護理和治療費用. Public health. Part 70: Interstate quarantine. Section 70.13: Payment for care and treatment. CFR 42-70.14-2017 公共衛生.第70部分：州際隔離.第70.14節：有關發出聯邦檢疫、隔離或有條件釋放令的要求. Public health. Part 70: Interstate quarantine. Section 70.14: Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.15-2017 公共衛生.第70部分：州際隔離.第70.15節：強制重新評估用于隔離、隔離或條件釋放的聯邦訂單. Public health. Part 70: Interstate quarantine. Section 70.15: Mandatory reassessment of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.16-2017 公共衛生.第70部分：州際隔離.第70.16節：對聯邦隔離令、隔離令或有條件釋放令的醫學審查. Public health. Part 70: Interstate quarantine. Section 70.16: Medical review of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.17-2017 公共衛生.第70部分：州際隔離.第70.17節：與聯邦檢疫、隔離或有條件釋放有關的行政記錄. Public health. Part 70: Interstate quarantine. Section 70.17: Administrative records relating to Federal quarantine, isolation, or conditional release. CFR 42-405.373-2017 公共衛生.第405部分：老年人和殘疾人聯邦醫療保險.第C子部分：暫停付款，追回多付款項，償還獎學金和貸款.第405.37節：程序用于抵銷或收回的定金. Public health. Part405: Federal health insurance for the aged and disabled. Subpart C: Suspension of payment, recovery of overpayments, and repayment of scholarships and loans. Section405.373 : Proceeding for offset or recoupment. CFR 42-405.2413-2017 公共衛生.第405部分：老年人和殘疾人聯邦醫療保險.第X子部分：農村衛生診所和聯邦合格醫療中心服務.第405.2413節：與醫生服務有關的服務和用品. Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2413 : Services and supplies incident to a physician's services. CFR 42-405.2415-2017 公共衛生.第405部分：老年人和殘疾人聯邦醫療保險.第X子部分：農村衛生診所和聯邦合格醫療中心服務.第405.2415節：服務事故和直接監督. Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2415 : Incident to services and direct supervision. CFR 42-410.26-2017 公共衛生.第410部分：補充醫療保險福利.第 B子部分：醫療和其他衛生服務.第410.26節：向醫生提供的服務和用品事件：條件. Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.26 : Services and supplies incident to a physician's professional services: Conditions. CFR 42-410.79-2017 公共衛生.第410部分：補充醫療保險福利.第 B子部分：醫療和其他衛生服務.第410.79節：醫療保健糖尿病預防方案擴大模式：覆蓋條件. Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.79 : Medicare Diabetes Prevention Program expanded model: Conditions of coverage. CFR 42-411.357-2017 公共衛生.第411部分：醫療保險除外和醫療保險支付的限制.第 J子部分：提供指定保健服務的醫生和實體之間的財務關系.第411.357 節：與賠償安排有關的禁止轉介的例外情況. Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.357: Exceptions to the referral prohibition related to compensation arrangements. CFR 42-411.372-2017 公共衛生.第411部分：醫療保險除外和醫療保險支付的限制.第 J子部分：提供指定保健服務的醫生和實體之間的財務關系.第411.372 節：提交請求的程序. Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.372: Procedure for submitting a request. CFR 42-414.22-2017 公共衛生.第414部分：支付b部分醫療和其他衛生服務費用.第B子部分：醫生和其他從業人員.第411.372 節：相對價值單位(RVU). Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.22: Relative value units (RVUs). CFR 42-414.90-2017 公共衛生.第414部分：支付b部分醫療和其他衛生服務費用.第B子部分：醫生和其他從業人員.第414.90節：醫師質量報告制度. Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.90: Physician Quality Reporting System (PQRS). CFR 42-414.94-2017 公共衛生.第414部分：支付b部分醫療和其他衛生服務費用.第B子部分：醫生和其他從業人員.第414.94節：先進診斷成像服務的適當使用標準. Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.94: Appropriate use criteria for advanced diagnostic imaging services. ANSI/AAMI/ISO 13408-6-2005 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 systems ANSI/AAMI/ISO 13408-7-2012 保健產品的無菌加工.第7部分:非典型醫療設備和組合產品用替換加工 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products ASTM E1327-2007 利用手指甲區域評估抗菌洗手液配方的標準試驗方法 Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions ASTM E1714-2000 通用保健識別符(UHTD)特性的標準指南 Standard Guide for Properties of a Universal Healthcare Identifier (UHID) ASTM E1891-2010a 測定抗菌劑抗選定微生物的生存曲線和計算D值及濃度系數的標準指南 Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient ASTM E2042-1999 可控區域和清潔室的清潔和維修的標準實施規程 Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms ASTM E2720-2010 當表層沾有人體病原性病毒時用于評估透氣材料凈化程序效能的標準試驗方法 Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses ASTM E2721-2010 評定遭到含有人類致病性病毒的飛沫攻擊時表面凈化程序效能的標準試驗方法 Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses ASTM E2799-2011 用 MBEC 化驗測試消毒劑對綠膿桿菌(Pseudomonas aeruginosa)生物膜功效的標準試驗方法 Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay ASTM E3058-2016 手消毒劑殺傷活性測定方法 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations ASTM F1114-2006 商業用的熱消毒筒,槽和架式水驅動旋轉噴射器皿站 Standard Specification for Heat Sanitizing Commercial Pot, Pan, and Utensil Station Rack Type Water-Driven Rotary Spray 英國 BS 3970-1-1990 醫療制品用滅菌消毒設備.第1部分:一般要求規范 Sterilizing and disinfecting equipment for medical products. Specification for general requirements BS 3970-2-1991 醫療制品用滅菌消毒設備.第2部分:裝含水液體的密封硬質容器用蒸汽消毒器規范 Sterilizing and disinfecting equipment for medical products. Specification for steam sterilizers for aqueous fluids in sealed rigid containers BS 6256-1989 醫用蒸汽消毒紙袋、紙盒和紙筒用紙規范 Specification for paper for steam sterilization paper bags, pouches and reels for medical use BS CWA 15793-2011 實驗室生物危害管理 Laboratory biorisk management BS CWA 16833-2014 整體管理棕色地帶更新的術語表 (GoT-HOMBRE) Glossary of Terms for Holistic Management of Brownfield Regeneration (GoT-HOMBRE) BS DD CEN ISO/TS 17665-2-2009 保健產品的消毒.潮熱.ISO 17665-1應用指南 Sterilization of health care products - Moist heat - Guidance on the application of ISO 17665-1 BS EN 13549-2001 清潔服務.質量度量系統的基本要求和推薦方法 Cleaning services - Basic requirements and recommendations for quality measuring systems BS EN ISO 11137-3-2007 衛生保健產品的滅菌.輻射.劑量測定方面的指南 Sterilization of health care products - Radiation - Guidance on dosimetric aspects BS EN ISO 11140-3-2009 保健品滅菌.化學指示劑.蒸汽滲透布維-狄(Bowie和Dick)型試驗2級指示劑系統 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test BS EN ISO 15882-2008 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 results BS ISO 11140-5-2007 衛生保健品滅菌.化學指示劑.布維-狄(Bowie和Dick)型除氣試驗用2級指示劑 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests BS ISO 21527-1-2008 食品和動物飼料的微生物學.酵母和霉菌的計數用水平方法.水活性大于0.95的產品用菌落計數技術 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Colony count technique in products with water activity greater than 0,95 BS PAS 5748-2014 醫院清潔服務的規劃, 應用, 測量以及審查規格 Specification for the planning, application, measurement and review of cleanliness services in hospitals 德國 DIN 58949-2-2014 消毒。蒸汽消毒儀 第二部分：要求 德語和英語文本 Disinfection. Steam disinfection apparatus. Part2: Requirements; Text in German and English DIN 58949-3-2012 消毒 蒸汽消毒裝置 第三部分：效率測試 Disinfection. Steam disinfection apparatus. Part3: Efficiency testing DIN 58949-4-2014 消毒。蒸汽消毒儀 第4部分：功效測試的生物指標 Disinfection. Steam disinfection-apparatus. Part4: Biological indicators for efficacy tests DIN 58949-6-2015 消毒。蒸汽消毒儀 第六部分：蒸汽消毒設備的運行，其安裝要求及其供應來源 Disinfection. Steam disinfection apparatus. Part6: Operation of steam disinfection apparatus, their requirements for the installation and their supply sources DIN EN 285-2016 滅菌。蒸汽滅菌器。大型消毒器 Sterilization. Steam sterilizers. Large sterilizers; German version EN285:2015 DIN V ENV 12612-1997 醫療信息技術.衛生行業行政管理信息交換報文 Medical informatics - Messages for the exchange of healthcare administrative information; English version ENV 12612:1997 法國 NF S98-101-2-2008 衛生保健品的消毒.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 11135-1. NF V08-040-1-2008 食品和動物飼料的微生物學.酵母和霉菌的計數的水平方法.第1部分:水活性大于0.95的產品用菌落計數技術 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Part 1 : colony count technique in products with water activity greater than 0,95. 日本 JIS K3801-2000 微生物用HEPA過濾器的試驗方法 Test method of HEPA filters for microbiological use JIS T7328-2005 醫用甲醛氣消毒器 Formaldehyde gas disinfecters for medical use 韓國 KS P 6115-2006 醫用氧化乙烯氣體消毒器 Ethylene oxide gas sterilizers for medical use KS P 6116-2006 醫用氧化乙烯氣體消毒器(小型) Ethylene oxide gas sterilizers for medical use(Small size) 其他國家 CAN/CSA-ISO 13958-2011 主要用于血液分析和相關治療(第一版) Concentrés pour hémodialyse et thérapies apparentées (Première édition) CAN/CSA-Z22870-2007 重點護理即時檢驗(POCT). 質量和能力的要求(第一版) Point-of-care testing (POCT) - Requirements for quality and competence (First Edition) CSA EXP06-2015 評價預防感染和控制感染的新材料和技術(第一版) Evaluating emerging materials and technologies for infection prevention and control (First Edition) GOST 10385-2014 魚類綜合飼養人員. 通用規格 Combined feeding staffs for fishes. General specifications GOST 32375-2013 人類危險化學品檢測. 皮膚過敏 Testing of chemicals of human hazard. Skin sensitisation GOST R 56677-2015 人身防范工程手段. 編碼, 標識和標記. 通用要求 Means of physical protection engineering. Coding, identification and marking. General requirements AS/NZS 3896-2008 水.包括嗜肺軍團菌的在內的軍團菌的檢查 Waters—Examination for Legionella spp. including Legionella pneumophila SNZ PAS 8170-2005 初級衛生保健實踐管理系統 PRIMARY HEALTHCARE PRACTICE MANAGEMENT SYSTEMS SANS 1780-2018 一般用途過氧化氫和過氧乙酸產品的殺菌效果 Bactericidal efficacy of peroxide and peracetic acid based products for general use. UL 2783 BULLETIN-2015 UL安全標準 即時性手消毒產品的可持續性 Ul Standard For Safety Sustainability Of Instant Hand Antiseptic Products (Comments Due: March 16, 2015) 第三部份 手套相關國內外標準 國別 標準號 中文題名 英文題名 中國 GB 7543-2006 一次性使用滅菌橡膠外科手套 Single-use sterile rubber surgical gloves GB 10213-2006 一次性使用醫用橡膠檢查手套 Single-use medical rubber examination gloves GB/T 21869-2008 醫用手套表面殘余粉末的測定 Medical gloves.Determination of removable surface powder GB/T 21870-2008 天然膠乳醫用手套水抽提蛋白質的測定. 改進Lowry法 Medical gloves made from natural rubber latex.Determination of water-extractable protein using the modified lowry method GB 24786-2009 一次性使用聚氯乙烯醫用檢查手套 Single-use medical poly (vinyl chloride) examination gloves GB 24788-2009 醫用手套表面殘余粉末、水抽提蛋白質限量 Limit for the removable surface powder and water-extractable protein of medical gloves YY/T 0616.1-2016 一次性使用醫用手套.第1部分: 生物學評價要求與試驗 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation YY/T 0616.2-2016 一次性使用醫用手套 第2部分: 測定貨架壽命的要求和試驗 Medical glove for single use.Part 2:Requirements and testing for shelf life determination YY/T 0616.3-2018 一次性使用醫用手套 第3部分: 用倉貯中的成品手套確定實際時間失效日期的方法 Medical gloves for single use.Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions YY/T 0616.4-2018 一次性使用醫用手套 第4部分: 抗穿刺試驗方法 Medical glove for single use.Part 4:Test method for the puncturation resistance YY/T 0616.5-2019 一次性使用醫用手套 第5部分: 抗化學品滲透 持續接觸試驗方法 Medical gloves for single use Part 5: Test Method for Permeation of Chemicals under Conditions of Continuous Contact CNS 12543-1997 外科手術用橡膠手套 Surgical rubber gloves CNS 12837-1991 一般醫療用聚氯乙烯手套 Polyvinyl Chloride Medical Gloves CNS 12838-1991 一般醫療用聚氯乙烯手套檢驗法 Method of Test for Polyvinyl Chloride Medical Gloves 國際 ISO 11193-1-2008 一次性醫用檢驗手套. 第1部分: 橡膠乳膠或膠液制手套規范 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution ISO 11193-1 AMD 1-2012 一次性醫用檢驗手套. 第1部分: 橡膠乳膠或膠液制手套規格.修改件1 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1 ISO 11193-2-2006 一次性醫用檢查手套. 第2部分: 聚乙烯(氯乙烯)制手套規范 Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride) ISO 12243-2003 醫用天然膠乳手套 用改性格雷法測量可水萃取的蛋白質 Medical gloves made from natural rubber latex determination of water-extractable protein using the modified lowry method first edition ISO 21171-2006 醫療專用手套.可移動表面粉末的測定 Medical gloves - Determination of removable surface powder 歐洲　 EN 455-1-2000 一次性醫用手套. 第1部分: 無孔試驗和要求 Medical gloves for single use. Part 1: Requirements and testing for freedom from holes EN 455-2-2015 一次性醫用手套. 第2部分: 物理性能要求和試驗 Medical gloves for single use - Part 2: Requirements and testing for physical properties EN 455-3-2015 一次性醫用手套 第3部分:生物評定要求和試驗 Medical gloves for single use. Part 3:Requirements and testing for biological evaluation EN 455-4-2009 一次性醫用手套. 第4部分: 保質期測定要求和檢驗 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination CEN/TR 16953-2017 一次性醫用手套. 選擇指南 Medical gloves for single use - Guidance for selection EN ISO 21171-2006 醫療專用手套.可移動表面粉末的測定 ISO 21171-2006 Medical gloves Determination of removable surface powder 美國 ASTM D3578-2019 橡膠檢驗手套標準規范 Standard Specification for Rubber Examination Gloves ASTM D5151-2006(2015) 檢測醫用手套漏孔的標準試驗方法 Standard Test Method for Detection of Holes in Medical Gloves ASTM D5250-2019 醫用聚氯乙烯手套的標準規范 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application ASTM D6124-2006(2017) 醫用手套殘余粉末的標準試驗方法 Standard Test Method for Residual Powder on Medical Gloves ASTM D6319-2000a(2005) 醫用腈橡膠檢驗手套的標準規范 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-2010 醫用腈類檢驗手套的標準規范 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-2019 醫用腈檢驗手套規格 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6355-1998(2003) 醫用手套人重復損害修補試驗的標準試驗方法 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves ASTM D6977-2019 醫療檢查用氯丁橡膠手套的標準規格 Standard Specification for Polychloroprene Examination Gloves for Medical Application ASTM D6978-2005(2019) 醫用手套對化療藥物滲透阻力的評價的標準操作規程 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ASTM D7102-2010 測定無菌醫用手套上的內毒素的標準指南 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves ASTM D7103-2018 醫用手套評定的標準指南 Standard Guide for Assessment of Medical Gloves ASTM D7160-2016 醫用手套有效期測定的標準實施規程 Standard Practice for Determination of Expiration Dating for Medical Gloves ASTM D7161-2016 測定典型倉庫條件下存放的成熟醫用手套實時有效期的標準實施規程 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions ASTM D7907-2014 測定醫用檢查手套表面殺菌作用的標準試驗方法 Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves ANSI/ADA 102-1998 牙醫用無菌丁二烯手套 Non-Sterile Nitrile Gloves for Dentistry ANSI/ADA 103-2001 牙醫用無菌增塑聚氯乙烯手套 Non-Sterile Polyvinyl Chloride Gloves for Dentistry 英國 BS EN 455-1-2000 一次性醫用手套 無孔要求和測試 Medical gloves for single use. Requirements and testing for freedom from holes BS EN 455-2-2015 一次性醫用手套.物理性質的要求和測定 Medical gloves for single use. Requirements and testing for physical properties BS EN 455-3-2015 一次性醫用手套 第3部分:生物評定要求和試驗 Medical gloves for single use. Requirements and testing for biological evaluation BS EN 455-4-2009 一次性醫用手套.第4部分: 測定貨架壽命的試驗和要求 Medical gloves for single use Part 4: Requirements and testing for shelf life determination BS EN ISO 21171-2006 醫療專用手套.可移動表面粉末的測定 Medical gloves - Determination of removable surface powder BS ISO 12243-2003+A1-2012 醫用天然膠乳手套 用改良的半細胞法測定水可萃取蛋白質 Medical gloves made from natural rubber latex. Determination of water-extractable protein using the modified Lowry method BS PD CEN/TR 16953-2017 一次性醫用手套. 選擇指南 Medical gloves for single use. Guidance for selection 德國 DIN 58133-2008 醫療壓縮襪 Medical compression hosiery DIN EN 455-1-2001 一次性醫用手套. 第1部分:密封性要求和檢驗 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes; German version EN 455-1:2000 DIN EN 455-2-2015 一次性醫用手套. 第2部分:物理特性用要求和試驗.德文版本EN 455-2-2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2015 DIN EN 455-3-2015 一次性醫用手套. 第3部分:生物評定要求和試驗;德文版本EN 455-3-2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015 DIN EN 455-4-2009 醫用手套一次性使用 第4部分：保質期確定的要求和測試; Medical gloves for single use. Part4: Requirements and testing for shelf life determination; German version EN455-4:2009 DIN EN ISO 21171-2006 醫療專用手套. 可移動表面粉末的測定 (ISO 21171-2006) Medical gloves - Determination of removable surface powder (ISO 21171:2006) English version of DIN EN ISO 21171:2006-08 法國 NF S97-004-2006 醫療專用手套. 可移動表面粉末的測定 Medical gloves - Determination of removable surface powder. 泰國 TIS 1056.1-2013 一次性醫用檢查手套. 第1部分: 橡膠乳膠或橡膠溶液制手套規范 Single-use medical examination gloves part 1: specification for gloves made from rubber latex or rubber solution TIS 1056-2005 一次性醫用檢查手套. 第1部分: 橡膠乳膠或橡膠溶液制手套規范 Single.use medical examination gloves.part 1: specification for gloves made from rubber latex or rubber solution 越南 TCVN 6343-1-2007 一次性醫用檢查手套. 第1部分: 橡膠膠乳或膠液制手套規范 Single-use medical examination gloves.Part 1: Specification for gloves made from rubber latex or rubber solution TCVN 6343-2-2007 一次性醫用檢查手套. 第2部分: 聚乙烯(氯乙烯)制手套規范 Single-use medical examination gloves.Part 2: Specification for gloves made from poly (vinyl chloride) 其他國家 GOST EN 455-1-2014 一次性醫用手套. 第1部分. 緊密性的測定方法 Medical gloves for single use. Part 1. Method for determination of tightness GOST EN 455-2-2014 一次性醫用手套. 第2部分. 物理特性的測定方法 Medical gloves for single use. Part 2. Method for determination of physical-mechanical properties GOST R 52239-2004 一次性醫療檢查手套. 第1部分: 橡膠乳膠或橡膠膠漿制手套規范 Single-use medical examination gloves. Part 1. Specification for gloves made from rubber latex or rubber solution GOST R 57397-2017 醫療檢查用橡膠手套. 技術要求 Rubber examination medical gloves. Technical requirements GOST R 57402-2017 醫用手套. 使用期限的測定 Medical gloves. Determination of expiration dating GOST R 57403-2017 醫用聚氯乙稀手套. 技術要求 Poly(vinyl chloride) medical gloves. Technical requirements GOST R 57404-2017 醫用手套. 質量評估指南 Medical gloves. Quality assessment guide SANS 11193-1-2010 一次性使用醫用檢查手套 第1部分：橡膠膠乳或橡膠溶液制成的手套規范 Single-Use Medical Examination Gloves Part 1: Specification For Gloves Made From Rubber Latex Or Rubber Solution SANS 15190-2016 醫用手套 安全要求 Medical laboratories - Requirements for safety LST EN 455-1-2001 一次性醫用手套. 第1部分:孔自由度試驗和要求 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes LST EN 455-2-2015 一次性醫用手套. 第2部分: 物理特性的要求和檢驗 Medical gloves for single use - Part 2: Requirements and testing for physical properties LST EN 455-3-2015 一次性醫用手套. 第3部分: 生物評價的要求和試驗 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation LST EN ISO 21171-2006 醫用手套表面殘余粉末的測定(ISO 21171-2006) Medical gloves - Determination of removable surface powder (ISO 21171:2006) SNI ISO 11193.1-2010 一次性醫用檢驗手套. 第1部分:用橡膠乳和膠液制成的手套規范 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution SNI ISO 11193.2-2010 一次性醫用檢查手套. 第2部分: 聚氯乙烯制成的手套規格 Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride) STN EN 455-1-2002 一次性醫用手套. 第1部分: 指孔間自由度的要求和試驗 Medical gloves for single use. Part 1: Requirements and testing for freedom from holes STN EN 455-2-2015 一次性醫用手套. 第2部分: 物理特性的要求和檢驗 Medical gloves for single use - Part 2: Requirements and testing for physical properties STN EN 455-4-2009 一次性醫用手套. 第4部分: 測定貨架壽命的要求和試驗 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination ABNT NBR ISO 11193-1-2009/Amd 1-2015 一次性醫用檢驗手套。第1部分：用膠乳或膠水制成的手套規范 ABNT NBR ISO 11193-1-2015 一次性醫用檢驗手套 Single-use medical examination gloves ABNT NBR ISO 11193-2-2013 一次性使用的醫療檢查手套 第2部分：由聚氯乙烯制成的手套 Single-use medical examination gloves Part 2: Specification for gloves made from poly (vinyl chloride) DS/EN 455-3-2007 一次性使用醫用手套第3部分:生物學評價要求和測試 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation DS/EN ISO 21171-2006 醫用手套可移動表面粉末的測定 Medical gloves - Determination of removable surface powder 第四部分 防護服相關國內外標準 國別 標準號 中文題名 英文題名 中國 GB 19082-2009 醫用一次性防護服技術要求 Technical requirements for single-use protective clothing for medical use GB/T 20097-2006 防護服一般要求 Protective clothing - General requirements YY 0318-2000 醫用診斷X射線輻射防護器具.第3部分:防護服和性腺防護器具 Protective device against diagnostic medical X-radiation.Part 3:Protective clothing and protective devices for gonads YY/T 0506.1-2005 病人、醫護人員和器械用手術單、手術衣和潔凈服 第1部分:制衣廠、處理廠和產品的通用要求 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 1:General requirements for manufacturers,processors and products YY/T 0506.2-2016 病人、醫護人員和器械用手術單、手術衣和潔凈服 第2部分：性能要求和試驗方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 2: Performance requirements and test methods YY/T 0506.4-2016 病人、醫護人員和器械用手術單、手術衣和潔凈服 第4部分：干態落絮試驗方法 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 4: Test method for linting in the dry state YY/T 0506.5-2009 病人、醫護人員和器械用手術單、手術衣和潔凈服 第5部分:阻干態微生物穿透試驗方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 5:Test method for resistance to dry microbial penetration YY/T 0506.6-2009 病人、醫護人員和器械用手術單、手術衣和潔凈服 第6部分:阻濕態微生物穿透試驗方法 Surigical drapes,gowns and clean air suits,used as medical devices,for patients,clinical staff and equipment. Part 6:Test method to determine the resistance to wet bacterial penetration YY/T 0506.7-2014 病人、醫護人員和器械用手術單、手術衣和潔凈服 第7部分:潔凈度-微生物試驗方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 7:Test methods for determination of cleanliness-mircrobial YY/T 0506.8-2019 病人、醫護人員和器械用手術單、手術衣和潔凈服 第8部分：產品專用要求 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 8-Special requirements for products YY/T 0689-2008 血液和體液防護裝備.防護服材料抗血液傳播病原體穿透性能測試.Phi-X174噬菌體試驗方法 Clothing for protection against contact with blood and body fluids.Determination of resistance of protective clothing materials to penetration by blood-borne pathogens.Test method using Phi-X174 bacteriophage YY/T 0699-2008 液態化學品防護裝備.防護服材料抗加壓液體穿透性能測試方法 Clothing for protection against liquid chemicals.Determination of the resistance of protective clothing materials to penetration by liquids under pressure YY/T 0700-2008 血液和體液防護裝備.防護服材料抗血液和體液穿透性能測試.合成血試驗方法 Clothing for protection against contact with blood and body fluids.Determination of the resistance of protective clothing materials to penetration by blood and body fluids.Test method using synthetic blood YY/T 1425-2016 血液和體液防護裝備.防護服材料抗血液和體液穿透性能測試.合成血試驗方法 Clothing for protection against contact with blood and body fluids.Determination of the resistance of protective clothing materials to penetration by blood and body fluids.Test method using synthetic blood YY/T 1498-2016 醫用防護服的選用評估指南 Guideline for evaluation of selection and use of medical protective clothing YY/T 1499-2016 醫用防護服的液體阻隔性能和分級 Liquid barrier performance and classification of protective apparel intended for use in health care facilities YY/T 1632-2018 醫用防護服材料的阻水性:沖擊穿透測試方法 Water resistance of textiles for medical protective apparel.Impact penetration test 國際 ISO 16603-2004 防止接觸血液和體液的防護服.防護服材料防止血液和體液滲透性的測定.使用人造血液的試驗方法 Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood ISO 16604-2004 防止接觸血液和體液的防護服.防護服材料防止血液病原滲透性的測定.使用Phi-X 174噬菌體的試驗方法 Clothing for protection against contact with blood and body fluids - Determination of resistance of protective clothing materials to penetration by blood-borne pathogens - Test method using Phi-X 174 bacteriophage ISO 22609-2004 傳染試劑防護服.醫療面罩.防人造血滲透的試驗方法(固定容積,水平噴射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) ISO 22612-2005 防傳感病病原體的防護服 防干微生物侵入能力的試驗方法 Clothing for protection against infectious agents test method for resistance to dry microbial penetration first edition 歐洲 EN 14126-2003 防護服.防傳病毒防護服的性能要求和試驗方法.合并勘誤表2004年9月 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents (Incorporating corrigendum September 2004) EN 14126-2003+AC-2004 防護服 抗感染防護服的性能要求和試驗方法 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents EN ISO 22612-2005 防傳感病病原體的防護服 防干微生物侵入能力的試驗方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration ISO 22612:2005 EN 61331-3-2014 醫用診斷x射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing@ eyewear and protective patient shields 美國 AAMI PB70-2012 FDA認可的用于衛生保健設施的防護服和防護單的液體阻隔性能及分類 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities FDA RECOGNIZED ANSI/PB70-2012 旨在用于醫療保健設施的防護服和防護層的液體屏障性能和分類（FDA認可） Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (FDA RECOGNIZED) ANSI/AAMI PB70-2012 醫療保健設施中使用的防護服和防護布的液體阻擋層性能和分類 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities ANSI/NFPA 1999-2008 急救醫療手術用防護服的標準 Standard on Protective Clothing for Emergency Medical Operations ASTM F903-2018 防護服用材料耐液體滲透性的試驗方法 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids ASTM F1670/F1670M-2017a 防護服材料對合成血液滲透的阻力的標準試驗方法 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ASTM F1671/F1671M-2013 使用Phi-X174噬菌體滲透作為試驗系統的血源性病原體對防護服使用的抗滲透材料用標準試驗方法 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System ASTM F2878-2019 防護服材料耐皮下注射針頭剌破性試驗方法 Standard Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture ASTM F3050-2017 個人防護服及設備合格評定指南 Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment NFPA 1999-2018 緊急醫療服務用防護服和服裝標準 Standard on Protective Clothing and Ensembles for Emergency Medical Operations (Effective Date: 8/21/2017) 英國 BS EN 14325-2018 化學藥品防護服 化學防護服裝材料、縫合線、聯結和組合的試驗方法和性能分類 Protective clothing against chemicals. Test methods and performance classification of chemical protective clothing materials,seams,joins and assemblages BS EN 61331-3-2014 防醫療診斷用X射線的防護裝置. 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear and protective patient shields BS EN ISO 13688-2013 防護服 通用要求 Protective clothing. General requirements BS EN ISO 22612-2005 傳染介質防護服.防干微生物滲入的試驗方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration BS ISO 16603-2004 防止接觸血液和體液的防護服.防護服材料防止血液和體液滲透性的測定.使用人造血液的試驗方法 Clothing for protection against contact with blood and body fluids. Determination of the resistance of protective clothing materials to penetration by blood and body fluids. Test method using synthetic blood 德國 DIN EN 61331-3-2016 防醫療診斷用X射線的防護裝置.第3部分:防護服,護目鏡和患者防護罩(IEC 61331-3-2014).德文版本EN 61331-3-2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014 DIN EN ISO 22612-2005 防傳感病病原體的防護服 防干微生物侵入能力的試驗方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration (ISO22612:2005); German version ENISO22612:2005 日本 JIS T8060-2015 血液和體液接觸的防護用服裝.血液和體液滲透防護服裝材料 Clothing for protection against contact with blood and body fluids -- Determination of the resistance of protective clothing materials to penetration by blood and body fluids -- Test method using synthetic blood JIS T8061-2015 防止接觸血液和體液的防護服 測定防護服材料對血源性病原體滲透的抵抗力 使用Phi-X174噬菌體的測試方法 Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage JIS T8062-2010 預防傳染性病原體的防護服.面罩.防止人造血漿滲透的試驗方法（確定容量,平行注射） Clothing for protection against infectious agents -- Face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) JIS T61331-3-2016 醫療診斷用X射線防護裝置. 第3部分: 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing, eyewear and protective patient shields 韓國 KS K ISO 22609-2012 傳染試劑防護服.醫療面罩.防人造血滲透的試驗方法(固定容積、水平噴射) Clothing for protection against infectious agents－Medical face masks－Test method for resistance against penetration by synthetic blood(fixed volume, horizontally projected) 其他國家 DS/EN 61331-3-1999 防止診斷醫療X射線輻射的保護裝置 - 第3部分:生殖器防護服和保護裝置 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads GOST R 57493-2017 醫療器械. 放射科材料防護服. 政府采購技術要求 Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases GOST R 57503-2017 醫療器械. 放射科患者防護服. 政府采購技術要求 Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases ABNT NBR IEC 61331-3-2004 防護服和性腺防護裝置-對診斷醫用X射線防護裝置第3部分 Protective devices against diagnostic medical X-radiation Part 3- Protective clothing and protective devices for gonads LST EN 61331-3-2014 醫用診斷x射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩(IEC 61331-3-2014) Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) UAE.S/GSO ISO 22609-2010 傳染試劑防護服.醫療面罩.防人造血滲透的試驗方法(固定容積,水平噴射) Clothing for protection against infectious agents -Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) STN EN 61331-3-2001 醫用診斷X射線輻射防護器具. 第3部分: 防護服和性腺防護器具 Protective devices against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads STN EN 61331-3-2015 醫用診斷X射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields IS 16545-2016 防止接觸血液和體液的衣服-血傳播致病菌對防護服材料滲透性的測定-Phi-X174噬菌體試驗方法 Clothing for Protection Against Contact with Blood and Body Fluids - Determination of Resistance of Protective Clothing Materials to Penetration by Blood-Borne Pathagens - Test Method Using Phi-X174 Bacteriophage IS 16546-2016 防止接觸血液和體液的衣服-血液和體液滲透性測定防護服材料的滲透性-合成血液的試驗方法 Clothing for Protection Against Contact with Blood and Body Fluids - Determination of the Resistance of Protective Clothing Materials to Penetration by Blood and Body Fluids - Test Method Using Synthetic Blood 第五部分 護目鏡相關國內外標準 國別 標準號 中文題名 英文題名 中國 GB 14866-2006 個人用眼護具技術要求 The specifications for personal eye-protectors 國際 ISO 4849-1981 個人用護目鏡 技術要求 Personal eye-protectors. Specifications first edition ISO 12609-1-2013 第1部分: 產品規范. 防護人體和動物用強光源用于化妝品和醫療用途的護目鏡. 第1部分: 產品規范 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications. Part 1: Specification for products 歐洲 EN 166-2001 個人眼睛保護 - 規格 Personal Eye-Protection. Specifications 英國 BS EN 61331-3-2014 防醫療診斷用X射線的防護裝置. 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear and protective patient shields 德國 DIN EN 61331-3-2016 防醫療診斷用X射線的防護裝置.第3部分:防護服,護目鏡和患者防護罩(IEC 61331-3-2014).德文版本EN 61331-3-2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014 法國 NF C74-228-3-2015 防醫療診斷用X射線的防護裝置. 第3部分: 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation - Part 3 : protective clothing, eyewear and protective patient shields 日本 JIS T8147-2016 個人眼睛防護 Personal eye protectors 韓國 KS G ISO 12609-1-2014 第1部分:產品規范。防護人體和動物用強光源用于化妝品和醫療用途的護目鏡。第1部分:產品規范 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products 其他國家 LST EN 61331-3-2014 醫用診斷x射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩(IEC 61331-3-2014) Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) STN EN 61331-3-2015 醫用診斷X射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields