1、生物危险等级附表一 生物安全等級規範及病原體微生物危險性等級分類危險群與生物安全等級、操作規範及設備對照表危險群RISK GROUP生物安全等級BIOSAFETY LEVEL實驗室類型LABORATORY TYPE實驗室操作規範LABORATORY PRACTICES安全設備SAFETY EQUIPMENT第一級1第一等級Biosafety Level 1基礎教學、研究Basic teaching, research優良微生物學技術GMT無,開放式工作檯None; open bench work第二級2第二等級Biosafety Level 2初級衛生服務、診斷服務、研究Primary hea
2、lth services; diagnostic services, research優良微生物學技術加上防護衣、生物危害標誌GMT plus protective clothing, biohazard sign開放式工作檯加上防止氣霧外流之生物安全櫃Open bench plus BSC for potential aerosols第三級3第三等級Biosafety Level 3特殊診斷服務、研究Special diagnostic services, research同第二等級加上特殊防護衣、進入管制及定向氣流As Level 2 plus special clothing, cont
3、rolled access, directional airflow生物安全櫃及(或)其他所有實驗室工作所需要之基本裝置BSC and/or other primary devices for all activities第四級4第四等級Biosafety Level 4具危險性之病原體Dangerous pathogen units同第三等級加上氣密門、出口淋浴及廢棄物之特殊處理As Level 3 plus airlock entry, shower exit, special waste disposal三級生物安全櫃或二級生物安全櫃並穿著正壓防護衣、雙門高壓蒸氣滅菌器(穿牆式)及經過濾
4、之空氣Class III BSC, or positive pressure suits in conjunction with Class II BSCs, double-ended autoclave (through the wall), filtered air病原微生物依其危險性為基礎之分類(依據行政院國家科學委員會九十三年六月增修之基因重組實驗守則)甲、第一級危險群(Risk group 1 , RG1)微生物第一級危險群微生物與人類健康成人之疾病無關。例如不產生內孢子之Bacillus licheniformis, Escherichia coli-K12, adeno-asso
5、ciated virus第一型至第四型,及重組的不含潛在致癌基因產物或毒素之adeno-associated virus,且在無輔助病毒存在下進行培養。乙、第二級危險群(Risk group 2 , RG2)微生物第二級危險群微生物在人類所引起的疾病很少是嚴重的,而且通常有預防及治療的方法。(一)細菌包括披衣菌1.Acinetobacter baumannii(以前稱為Acinetobacter calcoaceticus)2.Actinobacillus3.Actinomyces pyogenes(以前稱為Corynebacterium pyogenes)4.Aeromonas hydrop
6、hila5.Amycolata autotrophica 6.Archanobacterium haemolyticum(以前稱為Corynebacterium haemolyticum)7.Arizona hinshawii(所有血清型)8.Bacillus anthracis9.Bartonella henselae, B. quintana, B. vinsonii 10.Bordetella包括B. pertussis 11.Borrelia recurrentis, B. burgdorferi 12.Burkholderia(以前稱為Pseudomonas species;列於第三
7、級危險群者除外) 13.Campylobacter coli, C. fetus, C. jejuni 14.Chlamydia psittaci, C. trachomatis, C. pneumoniae15.Clostridium botulinum, Cl. chauvoei, Cl. haemolyticum, Cl. histolyticum, Cl. novyi, Cl. septicum, Cl. tetani 16.Corynebacterium diphtheriae, C. pseudotuberculosis, C. renale 17.Dermatophilus co
8、ngolensis 18.Edwardsiella tarda 19.Erysipelothrix rhusiopathiae 20.Escherichia coli(所有腸致病性、腸致毒性、腸侵襲性及攜帶有K1抗原的菌株,包括E. coli O157:H7) 21.Haemophilus ducreyi, H. influenzae 22.Helicobacter pylori 23.Klebsiella(除K. oxytoca(RG1)以外之所有菌株) 24.Legionella包括L. pneumophila 25.Leptospira interrogans(所有血清型) 26.Lis
9、teria 27.Moraxella 28.Mycobacterium(除了列於第三級危險群者)包括M. avium complex, M. asiaticum, M. bovis BCG vaccine strain, M. chelonei, M. fortuitum, M. kansasii, M. leprae, M. malmoense, M. marinum, M. paratuberculosis, M. scrofulaceum, M. simiae, M. szulgai, M. ulcerans, M. xenopi 29.Mycoplasma(M. mycoides及 M
10、. agalactiae除外) 30.Neisseria gonorrhoeae, N. meningitidis31.Nocardia asteroides, N. brasiliensis, N. otitidiscaviarum, N. transvaiensis 32.Rhodococcus equi 33.Salmonella包括S. arizonae, S. cholerasuis, S. enteritidis, S. gallinarum-pullorum, S. meleagridis, S. paratyphi, A, B, C, S. typhi, S. typhimur
11、ium 34.Shigella包括S. boydii, S. dysenteriae, type 1, S. flexneri, S. sonnei 35.Sphaerophorus necrophorus 36.Staphylococcus aureus 37.Streptobacillus moniliformis 38.Streptococcus包括S. pneumoniae, S. pyogenes 39.Treponema pallidum, T. carateum 40.Vibrio cholerae, V. parahemolyticus, V. vulnificus 41.Ye
12、rsinia enterocolitica(二)真菌1.Blastomyces dermatitidis2.Cladosporium bantianum, C.(Xylohypha)trichoides3.Cryptococcus neoformans 4.Dactylaria galopava(Ochroconis gallopavum)5.Epidermophyton6.Exophiala(Wangiella)dermatitidis7Fonsecaea pedrosoi8.Microsporum9.Paracoccidioides braziliensis 10.Penicillium
13、marneffei 11.Sporothrix schenckii 12.Trichophyton(三)寄生蟲1.Ancylostoma human hookworms包括A. duodenale, A. ceylanicum2.Ascaris包括Ascaris lumbricoides suum3.Babesia包括B. divergens, B. microti4.Brugia filaria worms包括B. malayi, B. timori5.Coccidia6.Cryptosporidium包括C. parvum7.Cysticercus cellulosae(hydatid c
14、yst, larva of T. solium)8.Echinococcus 包括E. granulosis, E. multilocularis, E. vogeli9.Entamoeba histolytica 10.Enterobius 11.Fasciola包括F. gigantica, F. hepatica 12.Giardia包括G. lamblia 13.Heterophyes 14.Hymenolepis包括H. diminuta, H. nana 15.Isospora 16.Leishmania包括L. braziliensis, L. donovani, L. ethi
15、opia, L. major, L. mexicana, L. peruvania, L. tropica 17.Loa loa filaria worms 18.Microsporidium 19.Naegleria fowleri 20.Necator human hookworms包括N. americanus 21.Onchocerca filaria worms包括O. volvulus 22.Plasmodium包括引起猿猴類疾病之P. cynomologi, P. falciparum, P. malariae, P. ovale, P. vivax 23.Sarcocystis
16、包括S. sui hominis 24.Schistosoma包括S. haematobium, S. intercalatum, S. japonicum, S. mansoni, S. mekongi 25.Strongyloides包括S. stercoralis 26.Taenia solium 27.Toxocara包括T. canis 28.Toxoplasma包括T. gondii 29.Trichinella spiralis 30.Trypanosoma包括T. brucei brucei, T. brucei gambiense, T. brucei rhodesiense
17、, T. cruzi 31.Wuchereria bancrofti filaria worms(四)病毒1.Adenoviruses, human-all types2.Arenavirusesa. Lymphocytic choriomeningitis virus(non-neurotropic strains)b. Tacaribe virus complexc.其他被特別引述而列名之病毒3.Bunyavirusesa. Bunyamwera virusb. Rift Valley fever virus vaccine strain MP-12c.其他被特別引述而列名之病毒4.Cal
18、civiruses5.Coronaviruses(SARS-Associated Coronaviruses列於第三級危險群除外)6.Flaviviruses(Togaviruses)- Group B Arbovirusesa. Dengue virus serotypes 1, 2, 3, and 4b. Japanese encephalitis virusc. Yellow fever virus vaccine strain 17Dd. 其他被特別引述而列名之病毒7.Hepatitis A, B, C, D, and E viruses8.Herpesviruses(Herpesvi
19、rus simiae(Monkey B virus)除外)a. Cytomegalovirusb. Epstein Barr virusc. Herpes simplex types 1 and 2d. Herpes zostere. Human herpesvirus types 6 and 79.Orthomyxovirusesa. Influenza viruses types A, B, and Cb.其他被特別引述而列名之壁蝨攜帶正黏液病毒 10.PapovavirusesAll human papilloma viruses 11.Paramyxovirusesa. Newcast
20、le disease virusb. Measles virusc. Mumps virusd. Parainfluenza viruses types 1, 2, 3, and 4e. Respiratory syncytial virus 12.ParvovirusesHuman parvovirus(B19) 13.Picornavirusesa. Coxsackie viruses types A and Bb. Echoviruses-all typesc. Rhinoviruses-all types 14.Poxviruses (Monkeypox virus及被管制的Alast
21、rim, Smallpox與Whitepox除外) 15.Reoviruses包括Coltivirus, human Rotavirus及Orbivirus(Colorado tick fever virus) 16.Rhabdovirusesa. Rabies virus-all strainsb. Vesicular stomatitis virus-實驗室調適的病毒株包括VSV-Indiana, San Juan及Glasgow 17.Togaviruses(參見Alphaviruses及Flaviviruses)Rubivirus(rubella)丙、第三級危險群(Risk group
22、 3 , RG3)微生物第三級危險群微生物在人類可以引起嚴重或致死的疾病,可能有預防及治療之方法。(一)細菌包括立克次氏菌1.Bartonella2.Brucella包括B. abortus, B. canis, B. suis3.Burkholderia(Pseudomonas)mallei, B. pseudomallei4.Coxiella burnetii5.Francisella tularensis6.Mycobacterium bovis(但BCG除外), M. tuberculosis7.Pasteurella multocida type B - buffalo and ot
23、her virulent strains8.Rickettsia akari, R. australis, R. canada, R. conorii, R. prowazekii, R. rickettsii, R. siberica, R. tsutsugamushi, R. typhi(R. mooseri)9.Yersinia pestis(二)真菌1.Coccidioides immitis(sporulating cultures;contaminated soil)2.Histoplasma capsulatum, H. capsulatum var. duboisii(三)寄生
24、蟲無(四)病毒與變性蛋白(Prions)1.Alphaviruses(Togaviruses)- Group A Arbovirusesa. Eastern equine encephalomyelitis virusb. Semliki Forest virusc. St. Louis encephalitis virusd.Venezuelan equine encephalomyelitis virus(含TC-83疫苗株)e. Western equine encephalomyelitis virusf. 其他被特別引述而列名之病毒2.Arenavirusesa. Flexalb.
25、Lymphocytic choriomeningitis virus(LCM)(neurotropic strains)3.Bunyavirusesa. Hantaviruses包括Hantaan virusb. Rift Valley fever virus4.Coronavirusesa. SARS-associated Coronaviruses (SARS-CoV)-相關實驗操作必須嚴格遵照本守則附表八之規定5.Flaviviruses(Togaviruses)- Group B Arbovirusesa. West Nile Virus b. Yellow fever virusc.
26、 其他被特別引述而列名之病毒6.Picornavirusesa. Polioviruses-all types, wild and attenuated7.PoxvirusesMonkeypox virus8.PrionsTransmissible spongioform encephalopathies(TSE)agents(Creutzfeldt-Jacob disease and kuru agents)9.Retrovirusesa. Human immunodeficiency virus(HIV)types 1 and 2b. Human T cell lymphotropic v
27、irus(HTLV)types 1 and 2c. Simian immunodeficiency virus(SIV) 10.RhabdovirusesVesicular stomatitis virus丁、第四級危險群(Risk group 4 , RG4)微生物第四級危險群微生物在人類可以引起嚴重或致死的疾病,但通常無預防及治療之方法。(一)細菌無(二)真菌無(三)寄生蟲無(四)病毒1.Arenavirusesa. Guanarito virusb. Lassa virusc. Junin virusd. Machupo viruse. Sabia2.Bunyaviruses(Nairo
28、virus)Crimean-Congo hemorrhagic fever virus3.Filovirusesa. Ebola virusb. Marburg virus4.Flaviruses(Togaviruses)- Group B ArbovirusesTick-borne encephalitis virus complex包括Absetterov, Central European encephalitis, Hanzalova, Hypr, Kumlinge, Kyasanur Forest disease, Omsk hemorrhagic fever及Russian spr
29、ing-summer encephalitis viruses5.Herpesviruses(alpha)Herpesvirus simiae(Herpes B或Monkey B virus)6.ParamyxovirusesEquine morbillivirus7.Hemorrhagic fever agents and viruses as yet undefined戊、通用的動物病原性病毒下列實驗室中常用的動物病原性病毒與健康成人之疾病無關。通常RG1級的防護等級即可。但對murine leukemia virus之amphotropic及xenotropic病毒株,建議於RG2級之防護等級下進行實驗。1.Baculoviruses2.Herpesvirusesa. Herpesvirus atelesb. Herpesvirus saimiric. Mareks disease virusd. Murine cytomegalovirus3.Papovavirusesa. Bovine papilloma virusb. Polyoma virusc. Shope papilloma virusd. Simian virus 40(SV40)4.Retrovirusesa. Avian leukosis virusb. Avian sarcoma virusc. Bo
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