IEC 60601 Pre-compliance Evaluation.
This evaluation is conducted prior submission of the equipment for compliance testing and aims to identify potential non-compliances and assist in resolving them as appropriate.
This including:
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Constructional review of the design and technical documents
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Risk management file evaluation to identify gaps and shortcomings to comply with ISO 14971 & the relevant and applicable clauses of IEC 60601
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Medical Equipment identification, markings and documents
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Accompanying documents requirements (user manual)
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Identification of critical components and their required certifications
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Electrical insulation review and creation of insulation diagram
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Where applicable, usability engineering file review to IEC 60601-1-6 & IEC 62366
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Where applicable, Software life-cycle processes review to IEC 62304 & clause 14 of IEC 60601
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Where applicable, Medical Equipment used in the home healthcare environment requirements of IEC 60601-1-11
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Where applicable, support with particular standards (IEC 60601-2-XX)
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Test plan – to identify the applicable testing and assist in choosing the appropriate routes for compliances.