Standard ANSI Z9.14: Testing and performance verification methodologies for ventilation systems for Biological Safety Level 3 (BSL-3) and animal Biological Safety Level 3 (ABSL-3) facilities

摘要

The American Industrial Hygiene Association (AIHA) and the American National Standards Institute (ANSI) are developing a national standard titled "Testing and performance verification methodologies for ventilation systems for Biological Safety Level 3(BSL-3) and animal Biological Safety Level 3 (ABSL-3) laboratories" known as ANSI/AIHA Z9.14. The ANSI Z9.14 standard will focus on performance verification of engineering controls related specifically to ventilation system features of BSL-3/ABSL-3 facilities. Currently the design of these facilities is largely guided by the criteria defined in successive versions of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), while facilities funded by the National Institutes of Health (NIH) follow BMBL as well as the NIH Design Requirements Manual (DRM). Among professionals such as architects, engineers, contractors, commissioning agents and owners who are asked to specify or perform tests for performance of ventilation systems in high containment facilities, there is a consensus that there is no comprehensive methodology based on a risk assessment of each individual facility. An extensive literature review was conducted to determine if there are any regulations, standards or guidance available that provide a "methodology" to verify that the ventilation systems in such facilities are performing appropriately for the current or potential future use. This 'Gap and Needs Analysis' provides evidence that there is no single resource for a comprehensive testing methodology that can be used uniformly from one facility to another to verify that the ventilation systems in such facilities are performing appropriately. ANSI Z9.14 can provide one component of a more extensive graduated, risk-based approach to reaching containment goals appropriate to the risk of the agent and the laboratory activity.