基于风险控制需求的生物安全防护装备性能评价体系

Performance Evaluation System for the Biosafety Protection Equipment Based on Risk Control Requirements

本文对生物安全防护装备的性能检测评价体系开展研究,相比于传统的防护设备检测技术,本文基于生物安全防护装备的实际使用特点及风险控制需求分析开展针对性研究,建立相应的适应性检测方法技术体系,研究成果保证了行业监管方尤其是实验室用户,可充分针对其不同实际需求对检测技术体系的适用性进行有效评价,并进行持续改进。

This paper introduced a performance evaluation system for the biosafety protection equipment used to protect the staff and environment in high level biosafety laboratories. Unlike the traditional evaluation system, this system is built based on the requirement analysis on the character of equipment operation and the corresponding risks. The whole system was then developed including performance requirements, test procedure and acceptance criteria. By providing transparent connection to the evaluation system and its aiming risks to be eliminated of the concerned equipment, all related parts, regulators, commissioners and users etc., would easily make effective evaluation for equipment they use and make continuous improvement and contribution to the system based on the individual requirements of different laboratories.