中國與歐盟醫(yī)用防護服標準指標比對情況ComparisonofMedicalProtectiveClothingStandards

1、中國與歐盟醫(yī)用防護服標準指標比對情況 Comparison of Medical Protective Clothing StandardsThe result of comparison between China's mandatory national standard GB19082-2009 technical requirements for disposable protective clothing for medical use and the EUstandard (EN 14126) is as follows. This result is summarized

2、 through the materials of standard comparison provided by Medical Device Standard Management Center of China Medical Products Administration,Science and Technology Development Department of China National Textile Industry Federation, National Technical Committee for Personal Protective Equipment Sta

3、ndardization and other relevant parties.For scope of application ：EN 14126 applies to reusable anti-virus protective clothing.GB 19082 applies to medical disposable protective clothing for medical personnel who comeinto contact with potentially infectious patients' blood, body fluids, secretions

4、 and airborne particles to provide barrier and protection.For physical properties of fabric ：EN 14126 refers to EN 14325, Chemical Protective Clothing -Chemical Protective Clothing Materials, Seams, Joints and the Test Method and Properties Classification of Components . EN 14325 requires that prote

5、ctive clothing should be tested and classified according to the fabric test methods and fabric performance classification system determined by the standard.GB19082 specifies two indexes such as elongation at break and fracture strength. Other indexes such as wear resistance, flexural resistance, fle

6、xural resistance (-30°C) and tear are notspecified.For barrier properties of fabric:EN 14126 mainly refers to international standard such as ISO 16603, ISO 16604, ISO 26610,ISO 26611 and ISO 26612. EU standardspecifies the classification requirements in five aspects including anti-synthetic blo

7、od penetration, anti-blood-borne pathogen (Phi-X174) bacteriophage contaminated liquid pressure penetration test, anti-wet microbial penetration test, anti-microbial aerosol test, and anti-dry microbial test.GB 19082 mainly specifies the requirements of the water resistance test, water testing, part

8、icle filtration efficiency and moisture permeability.For overall clothing performance:jointEN 14126 mainly specifies three indicators, namely, overall clothing performance test, strength and skin irritation, among whichtheoverall clothing performance refers to relevant international standards and EU

9、standards such as EN466. They are divided into protective suits against liquid aerosol and solid particles, liquid dense protective suits (Type3), spray dense protective suits (Type4), protective suits against solid particles (Type5), and protective suits against slight chemical liquid splash (Type6

10、).GB 19082 specifies six indicators, including requirements for microbial indicators, sterilization requirements, residual ethylene oxide, antistatic property, electrostatic attenuation and skin irritation.Comparison of key requirements from two standards is listed in table 4-1.Table 4-1 Comparison

11、of Key Technical Requirements from EN14126:2003 and GB19082-2009Sta ndard NumberGB 19082-2009EN 14126:2003Sta ndard NameTech ni calRequireme ntsforDisposable Protective Clothing for Medical UseProtective Clothi ng - Performa nee, Requireme nts and Test Methods for An ti-virus Protective Clothi ngSco

12、peThe standard standardizes the requirements for disposable protective clothi ng for medical use. This standard is applicable to medical disposable protective clothing for medical pers onnel who come into con tact with pote ntiallyin fectiouspatie nts'blood,body fluids,secretio nsandairbor ne pa

13、rticles to provide barrier and protectio n.Applicati ons:medicaldisposableprotective clothi ngThe sta ndard sta ndardizes the requireme nts and test methods for reusable,limited-usean ti-virusprotective clothing. The standard does not apply to protectiveclothingworn by first-linesurgicalpers onnel o

14、r surgical orders placed on the patie nt's body to preve nt cross-c on tam in atio n duri ng surgical in terve ntio n.Applicati ons:An ti-i nfective-substa neeprotectiveclothi ngTech ni cal TermsIn dex Requireme ntsTest MethodsIn dex Requireme ntsTest MethodsPhysical Properti es of FabricAbrasiv

15、e Resista n ceNoneMecha ni cal and flammability requireme nts: materials shall be tested and classified in accordanee with the test methods and performa nee classificati on system sta ndardized un der the releva nt provisi ons of pr EN 14325.Flexi ngResista n ceNoneFlexi ng Resista nee at-30(Optiona

16、l )NoneTearResista nceNoneElon gati onat BreakKey parts should not be less than 15%GB/T 3923.1-1997Fractu reStre ng thKey parts should not be less than 45NGB/T 3923.1-1997BarrierImpermeabilit yThe hydrostatic pressureGBT 4744-1997NoneProperties of FabricTestof key parts should be> 1.67kpaWater Te

17、st> Level 3GBT 4745-1997NoneParticleFiltrati onEfficie ncyThefiltrati onefficie ncy of Nacl at key parts and joints should be no less than 70%Article 5.7 ofGB 19082-2009NoneMoisture Tran smissi on> 2500g/(m2 d)Method A of GB/T12704-1991NoneResista nc t eoSyn theticBloodPen etrationLevel 1(0kPa

18、)Level 2 (1.75kPa)Level 3(3.5kPa)Level 4(7kPa)Level 5(14kPa)Level 6(20kPa)Annex A toGB 19082-2009Level 1(0kPa)Level 2 (1.75kPa)Level 3(3.5kPa)Level 4(7kPa)Level 5(14kPa)Level 6(20kPa)Classifivatio ntoISO 16603Should not < Level 2accord in g actual test results.Pressure pen etrati on test of con t

19、am in ated liquidaga in st blood-bor ne pathoge n (phi-x174) bacteriopha geNoneLevel 1(0kPa)Level 2 (1.75kPa)Level 3(3.5kPa)Level 4(7kPa)Level 5(14kPa)Level 6(20kPa)Classificatio naccord intog actual test results.ISO 16604Resista nc t eoMoistureMicrobePen etrati onNoneLevel 1(< 15mi n)Level 2(15&

20、lt;t < 30mi n)Level 3(30<t < 45mi n)Level 4(45<t < 60mi n)ISO 26610Level 5 (60<t < 75min)Level 6(t>75min )T is the breakthrough timeAn ti-microbi al Aerosol TestNoneLevel 1 (1<log < 3)Level 2(3<log < 5)Level 3 (log>5 )Log ispen etrati onISO 26611An ti-dry Micro

21、be TestNoneLevel 1 ( 2<log cfu < 3) Level 1(1<logcfu < 2) Level 3 (log cfu < 1)Log cfu is the penetration in dexISO 26612OverallClothi ng Performa n ceOverallClothi ng Performa nc e TestNoneSpecific requirements refer to other EN standards:Type 1 EN943-1( EN943-2 for emergency team (E

22、T)"airtight" chemical protective clothi ng)Type 3 EN 466Type 4 EN 465 ,Type 5 ISO 13982-1 ,Type 6 EN 13034Partial body protectio nEN 467Seam Stre ngthNoneEN 14325Microbiologi ca lIndexRequireme ntsThere are requireme nts for bacterialcolonydetect ionAnnex B toGB 15979-2002NoneSterilizati o

23、n Requireme nt sSterilizedandnon-sterilized.I f sterilized,thewords "sterile" shall be marked on the packageNoneResidualShould not exceedArticle 5.13 ofNoneEthyle n e Oxide10 u g/gGB19082-2009Ski n Irritatio nThe primary stimulus score should not exceed 1Article 5.11ofGB19082-2009Article 4

24、.3 of EN14126 requires that materials and desig ns used shall not cause skin irritati on or adverse health effects.An tista tic Propert yThe electric qua ntity of protective clothi ng should not exceed 0.6 口 C/pieceArticle 7.2 of GB/T 12703-1991NoneStatic DecayThe static decay time ofprotectivecloth

25、i ng should not exceed 0.5s.Article 5.10ofGB19082-2009NoneNote: The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.中國與歐盟醫(yī)用防護服標準指標比對情況經(jīng)匯總國家藥品監(jiān)督管理局醫(yī)療器械標準管理中心、 中國紡織工業(yè)聯(lián)合會科技發(fā)展部、 全國個體防護裝備標準 化技術

26、委員會等 相關方面提供的標準比對材料， 我國強制性國家標準 GB19082-2009 醫(yī)用一次性防護服技術 要求禾歐盟標準（EN14126）的比對情況如下。在適用范圍上， 歐盟標準（ EN 14126）適用于可重復使用的防傳病毒防護服。我國標準（GBI9082）適用于醫(yī)務人員在工作中接觸具有潛在感染性的患者血液、體液、分泌物、 空氣中的顆粒物等提供阻隔、防護作業(yè)的醫(yī)用一次性防護服。在面料物理性能上，歐盟標準（EN14126）引用EN14325防化學物質(zhì)的防護服一化學防護服的材料、接縫、接 頭和組件的測試方法和性能分類，要求面料應該根據(jù)該標準確定的測試方法和性能分類系統(tǒng)，對防護服產(chǎn)品 進行測試和

27、分類。我國標準（ GB 19082）規(guī)范了斷裂伸長率、斷裂強度等 2 項指標，耐磨性、耐屈撓性、耐 屈撓性（-30 C）、撕裂等其他指標未規(guī)范。在面料阻隔性上，歐盟標準（EN14126 主要引用ISO 16603、ISO 16604、ISO 26610、ISO 26611、ISO 26612 等國 際標準，規(guī)范了抗合成血液穿透性、抗血源性病原體（Phi-X174）噬菌體污 染性液體耐壓穿透測試、抗?jié)駪B(tài)微生物 穿透、防微生物氣溶膠測試、抗干態(tài)微生物測試等5方面的分等分級要求。我國標準（GB 19082主要規(guī)范了抗?jié)B水性測試、沾水性測試、 顆粒過濾效率、 透濕量。在服裝整體性能上，歐盟標準（EN14126）主要規(guī)范了整體服裝性能測試、接縫強度和皮膚刺激性等 3項指標, 其中整體服裝性能參考相關國際標準和 EN466 等歐盟標準，分為防液體氣溶膠和固體顆粒的防護服、 液體致密型 防護服（Type3）、噴霧致密型防護服（Type4）、防固態(tài)顆粒物防護服（Type5）、防輕度化學液體飛濺防 護服