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      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?!^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

      DB50/107-2003

      醫用紗布口罩

       

      DB62/T518-1998

      一次性使用無紡布系列醫療衛生用品

       

      DB65/T2028-2003

      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 顆粒防護用過濾半屏蔽 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 指導性檔

      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

      ASTMF 1862/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)

      ASTMF 2100-2019

      醫用口罩材料性能標準規范

      Standard Specification for Performance of Materials Used in Medical Face Masks

      ASTMF 2101-2019

      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

      ASTMF 2299/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

      CFR42-84-1995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 指導性檔

      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 S 76-014-2009

      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 S 76-034-1998

      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 S 97-166-2014

      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)

      第三部分 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-Part3:Protectiveclothing,eyewear and protective patient shields

      來源:質量與認證

      文章轉載:中國家電電器研究院測試計量技術研究所



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