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Thank you everyone, I have gotten a lot of great information from past posts. I finally have a topic which is new thread worthy.
We manufacture a battery powered device which gets EtO exposed, and my sterilizer just brought this to my attention:
[FONT="]Per ISO 11135:2007 - Medical devices containing batteries or other stored energy must be “Intrinsically Safe” as defined by the NFPA 70 standard for Class 1, Division 1, Group B hazard areas such as EO sterilization chambers. [/FONT][FONT="]
Has anyone dealt with this? Is intrinsically safe certification required? This could be tough since I think devices are typically hermetically sealed to achieve this requirement, which our product is not. We contain a 3 volt lithium battery which I think excludes us from the "simple apparatus" exclusion in the NFPA standard.
Any help is much appreciated. Glad to be on the forum.
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We manufacture a battery powered device which gets EtO exposed, and my sterilizer just brought this to my attention:
[FONT="]Per ISO 11135:2007 - Medical devices containing batteries or other stored energy must be “Intrinsically Safe” as defined by the NFPA 70 standard for Class 1, Division 1, Group B hazard areas such as EO sterilization chambers. [/FONT][FONT="]
Has anyone dealt with this? Is intrinsically safe certification required? This could be tough since I think devices are typically hermetically sealed to achieve this requirement, which our product is not. We contain a 3 volt lithium battery which I think excludes us from the "simple apparatus" exclusion in the NFPA standard.
Any help is much appreciated. Glad to be on the forum.
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