管腔型灭菌过程验证装置(PCD)适用性试验研究  

Applicability Comparison Experiments of Hollow Process Challenge Device

作　　者：曹原[1] 张剑[2] CAO Yuan ZHANG Jian

机构地区：[1]黑龙江省疾病预防控制中心 [2]中国疾病预防控制中心环境与健康相关产品安全所

出　　处：《环境卫生学杂志》2017年第4期310-314,共5页JOURNAL OF ENVIRONMENTAL HYGIENE

摘　　要：目的研究管腔型灭菌过程验证装置(PCD)在压力蒸汽灭菌器中不同测试条件下的适用性。方法在《医疗保健产品医疗化学指示物第4部分》(GB 18282.4-2009)附录B中的B1低大气压脉动、B2跨大气压脉动、B3高大气压脉动和EN867-5附录D中的低大气压脉动条件下,对管腔型PCD进行成功和失败试验,对比管腔型PCD在压力蒸汽灭菌器中不同测试循环、不同盘绕方式和放置方向状态下的试验结果。结果 B1和B3循环成功试验,不同盘绕方式和放置方向对PCD试验结果无影响;失败试验框架盘绕和水平放置的PCD对B1和B3循环的不良真空试验较其它盘绕方式和放置方向的PCD更敏感;管腔型PCD对B1、B3循环空气注入不敏感,对B1循环空气泄漏达到3 500 mL时显示失败结果。管腔型PCD对EN867-5附件D低大气压循环的灭菌舱泄漏试验不敏感。B2循环成功试验未出现合格结果,故未进行其他失败试验。结论在大型压力蒸汽灭菌器中可以使用低大气压循环、高大气压循环和EN 867-5附件D中的低大气压循环对管腔型器械进行灭菌,并使用能代表管腔型器械结构难度的管腔型PCD进行监测,但跨大气压循环不适用。框架盘绕且水平放置的PCD对检测低大气压循环和高大气压循环抽真空深度不足较其他缠绕和放置方式的PCD更为敏感。管腔型PCD对低大气压循环和高大气压循环时的空气注入不敏感,对低大气压循环中的空气泄漏只有达到足够量时才能检测得到。Objective To study the applicability of hollow process challenge device（ PCD） under different testing conditions in the steam sterilizer. Method The successful and unsuccessful experiments of hollow PCD were tested under B1 low atmospheric pressure impulse,B2 tranatmospheric pressure impulse,B3 high atmospheric pressure impulse in sterlization of health care products-chemical indicators-Part 4（ GB 18282. 4-2009）and the low atmospheric pressure impulse in appendix D in EN867-5 to contrast the experimental result of hollow PCD under different testing cycles,different coiling ways and placing direction in the steam sterilizer. Results There was no effects on the experimental result of PCD under the different coiling ways and placing directions to the successfully tests of B1 and B3 cycle. However,the hollow PCD under the framing coil and horizontal placement were more sensitive to the poor vacuum condition in B1 and B3 cycle than other placement of the PCD. The hollow PCD were not sensitive to air injection in B1 and B3. It showed unsuccessful result for the air leakage to3500 mL in B1 cycle. The hollow PCD was not sensitive to the leak test of the sterilizer in appendix D in EN867-5. The successful test of the B2 cycle failed,so no other failed experiments were carried out. Conclusions All of the test cycles（ B1,B3 and the low atmospheric pressure cycle in appendix D in EN867-5） could be used to sterilize the hollow devices. The hollow PCD can represent the complexed devices to monitored the sterilization except for the tranatmospheric pressure cycle. The hollow PCD under the framing coil and horizontal placement is more sensitive to detecting poor vacuum condition of B1 and B3 than other coiling ways and placing directions.Hollow PCD are not sensitive to the air injection in B1 and B3,but can detect the leakage when it is enough in the steam sterilizer.

关 键 词：管腔型PCD 压力蒸汽灭菌 盘绕方式 放置方向 

分 类 号：R187[医药卫生—流行病学]