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Posted by wu SUN (China) (Questions: 2, Answers: 0)
Asked on March 5, 2019 3:44 am
195 views
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Dear wu SUN.

If your sterilizer was not using in long time in European countries usually use validation procedure to verify that steam sterilizer working correct. I do not know law about this in China, but in Russian federation working ISO 13683 “Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities.” You can find information about validation procedure in point 7 “Validation of sterilization process”.
If we are speaking, about some kind of “major repairs” it’s depending from what kind of “major repairs” you were did. If you change chamber seals, or valve, or heating element you do not need to do revalidation procedure. But if you do welding on chamber or steam generatior –you should did it.

Hope it’s help.

Petr Demidov, Moscow, Russia, drpedro@mail.ru

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Posted by Petr Demidov (Russia) (Questions: 0, Answers: 24)
Answered on March 5, 2019 11:24 am
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Qualification testing for big steam sterilizer

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For some special reason, the sterilizer has stopped working for more than one month. How to verify it when the sterilizer is reused? Can we refer to other verification methods(for example: installation, relocation, malfunctions, major repairs)?

Marked as spam
Posted by wu SUN (China) (Questions: 2, Answers: 0)
Asked on March 5, 2019 3:44 am
195 views
0
Private answer

Dear wu SUN.

If your sterilizer was not using in long time in European countries usually use validation procedure to verify that steam sterilizer working correct. I do not know law about this in China, but in Russian federation working ISO 13683 “Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities.” You can find information about validation procedure in point 7 “Validation of sterilization process”.
If we are speaking, about some kind of “major repairs” it’s depending from what kind of “major repairs” you were did. If you change chamber seals, or valve, or heating element you do not need to do revalidation procedure. But if you do welding on chamber or steam generatior –you should did it.

Hope it’s help.

Petr Demidov, Moscow, Russia, drpedro@mail.ru

Marked as spam
Posted by Petr Demidov (Russia) (Questions: 0, Answers: 24)
Answered on March 5, 2019 11:24 am
« Back to Previous Page

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