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防褥瘡氣床墊產品技術審查要點 (產品適用的相關標準 (ISO 780:1997 - Packaging -- Pictorial marking…
防褥瘡氣床墊產品技術審查要點
產品適用的相關標準
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IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
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