CMK認證服務(蘇州)有限公司
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(0512)69574816
CMK認證服務(蘇州)有限公司
CMK Certification (Suzhou) Co., Ltd
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。本文將大家比較關心的防護服的相關國內外標準進行整理匯編，僅供參考。
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國別 |
標準號 |
中文題名 |
英文題名 |
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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 |
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GB/T 20097-2006 |
防護服一般要求 |
Protective clothing - General requirements |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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 |
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BS EN ISO 13688-2013 |
防護服 通用要求 |
Protective clothing. General requirements |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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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) |
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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) |
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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 |
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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 |
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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 |
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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 |
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