Temperature and Humidity Distribution Testing

ЭТО стерилизаций камерын температур диапазонжо 30-60°C коклаште лийшаш. Стерилизаторын кӧргӧ ӱмбалжын температур шеледымашыжым тергаш да стерилизаций камерыште температур ден вӱдыжгылыкым шеледымаш тергымашым эртараш темлалтеш, тыге шокшо да вӱдыжгӧ системын пайдалыкшым ӱшандарыше.

a) Internal Surface Temperature Test of ETO Sterilization Chamber:

• During the test, the sterilization chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
• The temperature of any preheating stage as specified by the sterilizer manufacturer should be recorded. Стерилизаций камерын чыла кӧргӧ ӱмбалжын температуржо стерилизаций этапын палемдыме температуржо деч ±5°C деч кугурак лийшаш огыл.

b) Temperature and Humidity Test in the ETO Sterilization Chamber:

• During the test, the ETO Sterilization Chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
• Use temperature and humidity sensors placed in specified positions to compare with the control temperature inside the chamber. The temperature sensors should be placed at locations likely to represent the maximum temperature differences, such as unheated parts of the chamber, near the cabinet doors, and near steam or gas entry points. Other sensors should be evenly distributed throughout the usable volume of the sterilization chamber, including the middle, top, bottom, front, and rear. The number of sensors should meet the requirements in Appendix C of GB18279.1.
• The position of each measurement should be recorded, and the temperature and humidity in different areas of the sterilization chamber should be recorded to identify potential hot spots and cold spots.
• The indoor temperature range of the sterilization chamber when empty should not exceed ±2°C of the set temperature or ±3°C of the average temperature inside the chamber.

Vacuum Pumping Rate

• The vacuum system during the vacuum pumping phase should be able to evacuate the empty sterilization chamber to -75 kPa or lower. A pressure gauge should be connected to the vacuum test inlet to observe whether it meets the required standard.
• Производитель яра нагрузко условийыште -50 кПа да -75 кПа марте шуаш кӱлшӧ жапым пеҥгыдемдышаш. Вакуумный насос фазым эскераш жапым шотлымо ӱзгарым кучылташ лиеш, а ончылгоч палемдыме параметр-влак палемдыме жапыште шукталтшаш улыт.

ЭТО стерилизаций шкаф утечка тергымаш

The ETO Sterilization Cabinet leakage test includes both vacuum (negative pressure) leakage testing and pressure (positive pressure) leakage testing (if applicable). Стерилизаторын паша давленийже 5 кПа деч кугурак годым давлений (положительный давлений) утечка тергымашым эртараш кӱлеш.

• The vacuum leakage test should be conducted before the sterilant injection phase and the humidification phase, with the testing method following the provisions of Appendix D.1 of YY0503. Тергымаш годым ончылгоч палемдыме давлений -20 кПа деч шагалрак да ончылгоч палемдыме стерилизаций давлений деч шагал огыл 20 кПа изирак лийшаш. Once the preset pressure is reached, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. Стерилизаций камерыште давленийым эскерыман, 5 минут жапыште давленийын кӱзымыжо 0,3 кПа/мин деч кугу лийшаш огыл. Пӱтынь тергымаш годым давленийын вашталтышыже 0,1 кПа/мин деч кугу лийшаш огыл.
• Positive pressure leakage testing (if applicable) should be conducted before the vacuum pumping phase. The preset pressure for the test should be within 10% of the sterilizer’s preset working pressure. The pressure drop within 5 minutes should not exceed 0.3 kPa/min. At the same time, according to the method in Appendix D.2 of YY0503, the sterilization time should be set to at least 65 minutes, using inert gas (such as air) to replace EO gas and run a normal sterilization cycle. After the sterilization phase reaches temperature stability for 2 minutes, the pressure in the sterilization chamber should be recorded. It should be recorded again after 60 minutes ± 1 minute. The pressure variation rate should not exceed 0.1 kPa/min.Auxiliary System Verification

During the operational verification, the performance of related auxiliary systems should be confirmed, including but not limited to: the quality of steam provided, the ability of the EO vaporizer to reach the minimum gas input temperature, the reliability of the sterilizer’s air filtration and water supply systems, and the ability of the steam generator to maintain the required supply quality under maximum sterilization load conditions.

Приемлемый полшышо системын пашажым ыштыме пример-влак: а) обрабатыватлыме этапыште парым пуртымо годым стерилизаций камерыште вӱдыжгылык шижалтеш вашталтышым ончыктышаш, а камер давленийым палемдыме давлений деч ±2,5 кПа кӧргыштӧ кучышаш. б) пуртымо ЭО газын температуржо испарительлан палемдыме эн изи значений деч кугурак лийшаш (мӧҥгешла, атмосфер давленийыште 10,7°C), тыге пуртымо ЭО газ формышто, а жидкостьышто огыл. в) Воздух фильтраций системын фильтраций пайдалыкше 0,3 микрон деч кугурак частице-влаклан 99,5% деч шагал огыл фильтраций скорость йодмашлан келшен толшаш. d) The water supply system should use purified water meeting the requirements of the 2020 edition of the Chinese Pharmacopoeia. e) The steam vapor pressure used for humidification in the sterilizer should not exceed 50 kPa.

ЭТО стерилизаций шкаф программе

During the sterilization process, the sterilization equipment software will control and monitor the sterilization process and evaluate the parameters of the sterilization cycle. Therefore, during the operational qualification process, the sterilization equipment software should be tested under all failure conditions (such as computerized measurement and control systems). Refer to the sterilizer’s user manual and equipment specifications, and test the software system’s functions in areas such as alarm handling, error processing, information management, parameter settings, historical record interfaces, sensor control and monitoring, and operational control and monitoring under conditions challenging the equipment’s operational limits.

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Сравоч-влак

ISO 11135:2014 Тазалыкым аралыме продукцийым стерилизаций — Этилен оксид — медицине ӱзгар-влакым стерилизаций процессым вияҥдыме, пеҥгыдемдыме да рутинный контрольым ыштыме шотышто йодмаш-влак

Аньхой провинций медицине прибор этилен оксид стерилизаций пеҥгыдемдыме паша ручка