EO灭菌记录

更新时间:2023-06-23 09:40:22 阅读：评论：0

Routine monitoring and control ISO 11135-1 2007 ction 10		ETO Sterilization Summary Report					Comment
Routine monitoring and control ISO 11135-1 2007 ction 10		Parameter Relea	Unit	Target Value	Min	Max	Comment
Precondition parameter 先决条件参数	Temperature in the chamber from a minimum of two locations throughout the sterilization cycle; ifud 从整个灭菌周期,含盖的两个地理位置的室内温度, （如果使用）	Temperature Min 最小温度	谈论人生Cᵒ	N/A	N/A	N/A	Not ud
	Temperature and humidity within the preconditioning area (if ud), monitored and recorded from a specified position; 预处理区域内的温度和湿度(如果使用),从指定的位置的监测和记录	Temperature	Cᵒ				Range requested
		Humidity	% RH				Range requested
	Time of commencement and of removal of load from preconditioning (if ud) of each sterilization load;鸡肉的英语怎么写从预处理每个灭菌负载的初次时间和去除负荷（如果使用）	Preconditioning Time	Mins				Range requested
Transfer Time 传输时间	Elapd time between removal of the sterilization load from preconditioning (if ud) and the commencement of the sterilization cycle; 从经过预处理（如果使用）消毒负荷的去除和灭菌周期开始之间的时间;	Transfer Time	Mins	N/A	N/A	N/A	Not ud
Sterilization ((Requested Parameters for relea of Sterile Medical Device as per ISO Standard))	Indication of the satisfactory operation of the chamber gas circulation system (if ud) during gas exposure; 在气体接触过程中的室内气体循环系统令人满意的操作指示(如果使用)	- Initial Gas Injection	Kpa			N/A	Information to be completed by supplier 信息需供应商提供
		好思想- End Gas Injection	Kpa				Information to be completed by supplier 信息需供应商提供
	Temperature and pressure in the chamber throughout the sterilization cycle 整个灭菌周期的室内温度和压力	-Exposure Temperature	Cᵒ	50	47	53	Parameters required in the certificate of sterilization to be nd to AMD-Ritmed for relea of sterile product 请供应商提供在消毒证书所需的参数.
		- Flushing Pressure	kPa	-15	-17	-13萎靡
		- Vacuum Pressure	kPa	-25	-27	-23
	Chamber humidity during conditioning by pressure and/or direct monitoring 在调节压力和/或直接监测的室内湿度	Exposure Humidity Range	%RH	30-85	29.7	93.5
	Evidence that the gaous ethylene oxide has been admitted to the sterilizer chamber; 环氧乙烷气体被送往消毒室的证据表明	Total Injection Gas Weight	Kg
	Pressure ri and the quantity of ethylene oxide ud or the concentration of ethylene oxide in the sterilizer chamber 在灭菌室的高压和乙烯乙烷或环氧乙烷的浓度数量	ETO concentration	mg/l	520	520
	Conditioning time 空调时间	Exposure Time	Mins	480	480	480
	Time, temperature, pressure changes (if any) and/or the operation of the air supply (if ud) during aeration. 舆论的力量在通风运作下的时间,温度,压力变化同一件事(如有)和/或供气操作(如果使用)	税收法规 Air Wash Time	Mins	15	15	30	No comment
		Aeration Time	Mins	3			Information to be completed by supplier
biological indicators	If biological indicators are ud in routine monitoring, they shall comply with 8.6. NOTE 1 See also 8.7. If chemical indicators are ud in routine monitoring, they shall comply with 8.8.	N/A	N/A	N/A	N/A	N/A	Not ud