医院药事

辅助生殖实验室空气质量和洁净环境控制的检测标准研究

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  • (1)中国食品药品检定研究院, 北京 100050; (2)北京市医疗器械检验所, 北京 101111; (3)重庆市妇幼保健院, 重庆 400013

网络出版日期: 2018-07-25

On the Testing Standards for Air Quality and Clean Environment Control of in vitro Fertilization Laboratories

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  • (1)National Institutes for Food and Drug Control, Beijing 100050, China; (2)Beijing Institute of Medical Device Testing, Beijing 101111, China; (3)Chongqing Health Center for Women and Children, Chongqing 400013, China

Online published: 2018-07-25

摘要

目的:为人类辅助生殖实验室洁净环境控制标准的制定提供数据支持。方法:参考现有的GB50333、GB 50325、GB/T 18883和GB/T 18204等标准,测试辅助生殖实验室空气质量和洁净环境控制的重要指标,考察检测方法的可行性和适用性。结果:1)空气中的苯和总挥发性有机化合物浓度的检测方法,在0.5μg·m-3~100 mg·m-3适用;当采样量为10 L时,检测下限为0.5μg·m-3;2)空气中的氡浓度的检测方法,在3~100000 Bq·m-3适用,该测试仪的灵敏度≥ 0.68 cpm·(Bq·m-3-1;3)空气中的甲醛检测方法,当采样量为10 L时,可检浓度范围为0.01~0.15 mg·m-3,该法的灵敏度为2.8μgHCHO/吸光度;4)空气中的臭氧检测方法在浓度范围为0.003~2 mg·m-3时,精密度优于±5%;准确度优于±4%。结论:参考现有的GB 50333、GB50325、GB/T 18883和GB/T 18204等标准中的方法可以有效检验IVF实验室的空气质量及洁净程度,灵敏度和检验范围均能满足实际测试要求。辅助生殖实验室应进一步加强实验室管理,重视空气质量及洁净环境控制。

本文引用格式

章娜, 杨超, 王会如, 陈鸿波, 黄国宁 . 辅助生殖实验室空气质量和洁净环境控制的检测标准研究[J]. 中国药事, 2018 , 32(7) : 959 -969 . DOI: 10.16153/j.1002-7777.2018.07.019

Abstract

Objective:To provide data for the establishment of standards for clean environment control of in vitro fertilization (IVF) laboratories. Methods:The key factors for air quality and clean environmental control of IVF laboratories were tested and the feasibility and applicability of testing methods were examined according to the standards of GB 50333, GB 50325, GB/T 18883, and GB/T 18204 etc. Results:1)The linear range of benzene in air and total volatile organic compounds was from 0.5 μg·m-3 to 100 mg·m-3; When the sampling volume was 10 L, the minimal detectable limit was 0.5 μg·m-3. 2)The linear range of radon concentration in the indoor atmosphere was from 3 Bq·m-3 to 100000 Bq·m-3. The sensibility of the testing equipment was ≥ 0.68 cpm·(Bq·m-3)-1. 3)The linear range of formaldehyde in the indoor atmosphere was from 0.01 mg·m-3 to 0.15 mg·m-3 when the sampling volume was 10 L, and the detection limit was 2.8 μg HCHO/Abs. 4)The linear range of ozone in the indoor atmosphere was from 0.003 mg·m-3 to 2 mg·m-3. The precision was better than ±5% and the accuracy was better than ±4% at m-3. Conclusion:The air quality and cleanness of IVF laboratories could be effectively tested by the existing methods according to the standards of GB 50333, GB 50325, GB/T 18883, and GB/T 18204 etc. The sensitivity and the testing ranges could meet the actual testing requirements. IVF laboratories should further strengthen the management and attach importance to the control of air quality and clean environment.

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