Under what circumstances do environmentatests need to be carried out on medical electricalequipment? - 分享质量人的知识和经验

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Under what circumstances do environmentatests need to be carried out on medical electricalequipment?

医疗器械技术评审

Under what circumstances do environmentatests need to be carried out on medical electricalequipment?

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ku1314520 一阶会员用户来自于: 广东省深圳市
2023-09-17 22:36

If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if the product performance and clinical effectare easily affected by environmental factors, the supporting data thatthe product can be used normally and stably in the correspondingenvironment shall be provided in the research data.If applicable, the related requirement of GB/T 14710 shouldbe specified in product technical requirement, and the test should beconducted according to requirement.

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发布时间: 2023-09-17 22:36

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