Biosafety
生物安全
1) 凡是病原微生物或疑似(包括可能的样品检测)病原微生物的操作均应在生物安全柜内操作,不宜在超净台内操作。
All tests related to (infectious) disease aetiology including sample tests should be operated in a bio-safety cabinet, not in laminar flow cabinet (standards).
2) 凡是安装生物安全柜的实验室不宜正压,对房间净化可不要求. 例如:霉菌实验室、微生物检验实验室和结核病实验室.
All the rooms that will install bio-safety cabinets should not run under positive pressure and need no requirements in cleaning degree.
3）生物安全柜 Biosafety cabinet
· 采购应考虑实验室高度报告。
· 应根据生物安全柜的不同类型设置不同的通风设施（如硬管连接、套管连接设施）。
· 要求厂家安装和安装后检测，并提供验证合格,任何国家的产品都需要检测,不合格者一律不能使用。
· 安装位置避免气流干扰和人员干扰(不靠近门窗、风口和人员流动多的位置)。
· When purchasing, CDC should consider the height of laboratory.
· Upon the different types of bio-safety cabinets, different ventilation establishments should be installed.
· During and after the installation of bio-safety cabinets, manufacturer must do on-site checking and safety validation according to national standard to make sure the bio-safety cabinet can comply with national standard. Any product from any country should be tested on site.
· Location place of bio-safety cabinet should avoid the disturbing of air and staff and should be positioned far from window, draught and polluted places.
4）BSL-2级实验室应符合国家标准（GB19489-2004和GB50346-2004）的最低要求，在硬件方面达到以下几点：
The conditions of BSL-2 labs should meet the minimum requirements of Laboratories - General Requirements for Biosafety (GB19489-2004), and Achitectual and technical code for biosafety laboratories (GB50346-2004), and the following points should be reached:
· 实验室门应带锁并可自动关闭。实验室的门应有可视窗。
The doors of the laboratory room should be lockable, be self-closing, and have vision panels;
· 应有足够的存储空间摆放物品以方便使用。在实验室工作区域外还应当有供长期使用的存储空间。
Storage space should be adequate to hold supplies for the convenience of use. Additional long-term utility storage space should also be provided outside the laboratory working areas;
· 在实验室内应使用专门的工作服；应戴乳胶手套。
Special work uniform and latex gloves should be provided for the laboratory;
· 在实验室的工作区域外应有存放个人衣物的条件。
Facilities for storing personal items should be provided outside the laboratory working areas;
· 在实验室所在的建筑内应配备高压蒸汽灭菌器，并按期检查和验证，以保证符合要求。
Autoclaves should be available in the laboratory building, and they should be checked and verified regularly to ensure their normal function;
· 应在实验室内配备生物安全柜。
Biosafty cabinets should be available in the laboratory;
· 应设洗眼设施，必要时应有应急喷淋装置。
Eyewash stations and, if necessary, emergency showers should be provided;
· 应通风，如使用窗户自然通风，应有防虫纱窗。
The laboratory should be ventilated. If windows are used for natural ventilation, they should be fitted with insect-proof screens.
· ⑨有可靠的电力供应和应急照明。必要时，重要设备如培养箱、生物安全柜、冰箱等应设备用电源。
There should be a reliable electricity supply and emergency lighting. When necessary, a stand-by power supply should be available for the support of important equipments, such as incubators, bio-safety cabinets, freezers, etc.
· ⑩实验室出口应有在黑暗中可明确辨认的标识。（包括逃生路线）
There should be signs that can be recognized in the dark to indicate exits of the laboratories.
5）涉及病原微生物检测的实验室（HIV、出血热、麻疹、结核、肝炎病毒、肠道病毒等），如为集中设置（即在同一层楼，不同房间）则可设置公用的清洁区（办公室等）和半污染区（工作服、鞋等），没有必要设置各自的清洁区和半污染区。所有检测操作区域均为污染区。
Where labs testing samples related to infectious diseases (HIV, Measles, TB, Hepatitis etc.) are on the same floor, it is better to arrange a public clean area (offices etc.) and semi-polluted area (to store uniforms, shoes etc.). There is no need to arrange different clean and semi-polluted areas separately. All the testing area is contaminated area.
6）PCR实验室 PCR labs
· PCR实验室应依据所使用的方法可分为试剂准备、样本制备、扩增和产物分析等三或四个区域，只是使用实时荧光PCR仪和HIV病毒载量测定仪的PCR实验室，有上述前面三个区域即可。各区域应完全独立分隔，不应有任何的空气直通。
Upon the used methods used in PCR lab, PCR labs should be divided in 3 or 4 areas, including reagent preparation area, samples preparation area, amplification area and products analyzing area. For PCR lab which only using real-time fluorescence PCR and instruments for HIV virus loading, the first three areas are acceptable. Each area should be separated completely and independently without any air flow (exchange) in between these areas.
· 产物分析区或三个区域的最后一个区域（即扩增及产物分析区）空气流向应由室外流向室内，可通过在室内设置通风橱和排风扇或其他排风系统来达到空气由室外向室内流动的要求。
Air flow in the last area of the PCR lab (amplification area or products analysing area) should be from outside to inside. Fume hood, air-exhausting fan or other ventilation systems can be installed indoors to reach this goal.
· 样本制备区域最好B2型的生物安全柜。
Class II B2 type bio-safety cabinet is preferred to be installed in the sample room.
1) 出血热、结核和HIV等实验室检测工作应按照卫生部《人间传染微生物名录》中实验活动所需生物安全实验室级别操作的要求，在BSL-2级实验室中进行即可。但当培养物确认为高致病微生物时，必须放在BSL-3级实验室进行。BSL-2级实验室的建设要求应符合《第（一）部分中的第（5）条》；
For haemorrhagic fever virus, TB and HIV rooms, the work should be operated in BSL-2 labs under the requirements of the List of Human Pathogenic Microorganisms issued by the Ministry of Health. If the culture materials could cause infections, all tests should be operated in BSL-3 labs. The construction of BSL-2 labs should meet the demands of Item 5, Part 1.
2）BSL-2级实验室门的开向应考虑与逃生方向一致，确保在实验室发生意外时工作人员的安全。
All laboratory doors should swing to the same direction of exit to ensure the safety of staff.
3）BSL-2级实验室的门应加上闭门器。
Auto-close device should be installed in doors of BSL-2 labs.
1）为确保安全，对临床和现场的未知样本检测操作可在生物安全二级或以上防护级别的实验室进行；
To ensure safety, clinical and on-site unknown samples should be operated in labs of BSL2 or beyond BSL2.
2）涉及病毒分离培养的操作，应加强个体防护和环境保护。要密切注意流行病学动态和临床表现，判断是否存在高致病性病原体；
For separation and culture of viruses, individual and environment protections should be enhanced.
3）若判定为疑似高致病性病原体，应在相应生物安全级别的实验室开展工作。
Tests related to highly pathogenic agents should be operated in labs with a corresponding bio-safety level.