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临床试验/NCT06697379
NCT06697379进行中(未招募)不适用

Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories

Minghui Li1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Performance evaluation of medical protective clothing

研究概览

简要总结

Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

详细描述

In high-level biosafety laboratories, the National Center for Infectious Disease Medicine, medical consortiums and other national platforms, systematic assessment of the project developed individual physical protection equipment in different scenarios of the safety performance, the intelligent application of the effect and the use of experience, the assessment of the indicators covering the protection performance, safety, stability, comfort, environmental protection, intelligence, ease of operation, including but not limited to local breakage protection performance, Aerosol protection performance, airtightness, liquid penetration performance, differential pressure stability, noise value, air supply flow, ease of wear and removal, ease of movement, ease of operation, degradability, degree of intelligence, etc., and ultimately determine the technical indicators and testing methods of individual physical protective equipment, and establish evaluation technical standards. Based on the determined technical indexes and testing methods of individual physical protective equipment, we will carry out parallel comparative evaluation of similar foreign imported equipment, and form a technical research report on the evaluation of the performance of relevant protective equipment. Optimise the quantitative performance indexes of PPE for domestic shortcomings and weaknesses. Prepare standard operation norms and technical standards for individual physical protective equipment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

排除标准

  • 未提供

结局指标

主要结局

Performance evaluation of medical protective clothing

时间窗: 3 years

Evaluate the performance of self-developed equipment versus commercially developed equipment, such as protective clothing, hoods, boots and gloves. Protective clothing: Surface moisture resistance: according to the standard including GB/T 4745-1997 on the level of water, the protective clothing outside the water level is not less than level 3 Hydrostatic pressure: according to GB/T 4744-1997, the hydrostatic pressure is not less than 1.67kPa or 17cmH2O. Moisture permeability: according to GB/T 12704-1991, the moisture permeability is not less than 2500g/(m²-24h). Water staining test: according to GB/T 4745-1997, the outer water staining level is not less than 3. Microbiological barrier performance: the protective clothing should meet the requirements of microbiological indicators in GB 15979-2002 to ensure that it can effectively block the invasion of bacteria, viruses and other microorganisms.

次要结局

  • Protective headgear performance evaluation(3 years)

研究者

发起方
Minghui Li
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Minghui Li

Doctor, Professor

Beijing Municipal Administration of Hospitals

研究点 (1)

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