How to determine the essential performance ofimmunity test in EMC test of active medical devices? - 分享质量人的知识和经验

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How to determine the essential performance ofimmunity test in EMC test of active medical devices?

医疗器械技术评审

How to determine the essential performance ofimmunity test in EMC test of active medical devices?

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ku1314520 一阶会员用户来自于: 广东省深圳市
2023-09-17 22:26

“Essential performance’ refers to the achievement ofperformance of a clinical function, other than that related to BASICSAFETY, where loss or degradation beyond the limits specified bythe manufacture results in an unacceptable riskWhen determining the essential performance of the product,the administrative counterparts shall consider but not limited to thefollowing aspects:

(1) Clinical safety risk;

(2) Performance related to diagnosis/treatment/ monitoring;

(3) Whether the performance of various sensors,cables,application parts, control devices, display devices, moving parts, etc.are affected by electromagnetic interference.

The essential performance shall be reflected in theaccompanying document (product specification) of the product, andthe identified essential performance shall be tested for immunityIf the essential performance is not identified, all functions of theproduct shall be taken as the essential performance for immunity test.

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发布时间: 2023-09-17 22:25

更新时间: 2023-09-17 22:26

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