can theelectrical safety and electromagnetic compatibility test beexempted? - 分享质量人的知识和经验

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can theelectrical safety and electromagnetic compatibility test beexempted?

医疗器械技术评审

When the registration certificate of activeproducts is changed, if there is no change to the electricalcomponents, but the shell structure and overall sealingperformance of the equipment are changed,can theelectrical safety and electromagnetic compatibility test beexempted?

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ku1314520 一阶会员用户来自于: 广东省深圳市
2023-09-17 22:34

The change of the shell structure and the overall sealingperformance of the equipment may lead to the change of theelectrical safety and electromagnetic compatibility performance. Theadministrative counterparts shall conduct an overall assessment ofthe change of the declared products and analyze the impact of thechange on the electrical safety and electromagnetic compatibilityperformance.If the change has an impact on the above-mentionedperformance,or if the standard terms of electrical safety andelectromagnetic compatibility need to be re judged or evaluated.the testing shall be carried out; if there is no impact and the relevantterms that need to be re judged or evaluated, the testing may not becarried out.

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发布时间: 2023-09-17 22:33

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