生物安全分类和控制水平

C. Y. William Tong
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引用次数: 0

摘要

《2002年危害健康物质管制条例》(COSHH)根据健康与安全执行局(HSE)批准的清单,将生物制剂分为四类(危害组)。生物制剂是指细菌、病毒、寄生虫和真菌,它们通常由于感染而对人体健康造成危害,尽管有些是有毒的或会引起过敏。批准的清单与生物制剂工作的风险评估和适当控制措施的应用有关。第1类危险物剂被认为不会对人类健康构成风险,而第4类危险物剂的风险最大。危险病原体咨询委员会(ACDP)根据以下内容(另见表13.1)制定了分类原则:●通过感染或毒性在人类中引起疾病的可能性;●感染向社区传播的可能性有多大;●预防或治疗的可用性。在决定适当的分类时,ACDP只考虑对人类健康的风险。一些列出的药物也可以引起动物疾病(人畜共患病),并且根据特定动物病原体命令(SAPO)也被分配了危害分类。在将人类病原体划分为危险组时,没有考虑到对那些易感感染可能受到影响的人的特殊影响,例如,由于已有疾病、药物、免疫力受损、怀孕或哺乳。2型脊髓灰质炎病毒已从危险组2重新分类为危险组3,以使联合王国符合世界卫生组织全球消灭脊髓灰质炎规划的期望。一旦减毒的2型脊髓灰质炎病毒不再作为三价脊髓灰质炎疫苗的一部分使用,这种重新分类也适用于这种病毒。寨卡病毒已从危险3类重新分类为危险2类,因为有大量证据表明,虽然它可以引起人类疾病,但通常是轻微的。它也不太可能从实验室传播到社区。COSHH条例为涉及使用生物制剂的活动规定了四个控制级别。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biosafety Categorisations and Containment Levels
The Control of Substances Hazardous to Health Regulations 2002 (COSHH) classifies biological agents into four categories (Hazard Groups) according to an approved list by the Health and Safety Executive (HSE). Biological agents are bacteria, viruses, parasites, and fungi that can cause harm to human health, usually due to infection, although some are toxic or can cause an allergy. The approved list is relevant to risk assessment for work with biological agents and the application of appropriate control measures. Hazard Group 1 agents are not considered to pose a risk to human health, while Hazard Group 4 agents present the greatest risk. The principle of the categorization is laid down by the Advisory Committee on Dangerous Pathogens (ACDP) based on the following (see also Table 13.1): ● the likelihood that it will cause disease by infection or toxicity in humans; ● how likely it is that the infection would spread to the community; and ● the availability of any prophylaxis or treatment. The ACDP only considers the risks to human health when deciding appropriate classification. Some listed agents can also cause disease in animals (zoonoses) and have also been assigned a hazard classification under the Specified Animal Pathogens Order (SAPO). In allocating human pathogens to a hazard group, no account is taken of particular effects on those whose susceptibility to infection may be affected, for example, because of pre-existing disease, medication, compromised immunity, pregnancy, or breastfeeding. Type 2 polio virus has been reclassified from Hazard Group 2 to Hazard Group 3 to bring the UK in line with the expectations of World Health Organization’s global polio eradication programme. This reclassification also applies to attenuated type 2 polio viruses once this component is no longer used as part of the trivalent polio vaccine. Zika virus has been reclassified from Hazard Group 3 to Hazard Group 2 as there is substantial evidence that while it can cause human disease, this is generally mild. It is also unlikely to spread to the community from the laboratory. COSHH regulations specify four containment levels for activities which involve working with biological agents.
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