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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:

  • Constructional review of the design and technical documents

  • Risk management file evaluation to identify gaps and shortcomings to comply with ISO 14971 & the relevant and applicable clauses of IEC 60601

  • Medical Equipment identification, markings and documents

  • Accompanying documents requirements (user manual)

  • Identification of critical components and their required certifications

  • Electrical insulation review and creation of insulation diagram

  • Where applicable, usability engineering file review to IEC 60601-1-6 & IEC 62366

  • Where applicable, Software life-cycle processes review to IEC 62304 & clause 14 of IEC 60601

  • Where applicable, Medical Equipment used in the home healthcare environment requirements of IEC 60601-1-11

  • Where applicable, support with particular standards (IEC 60601-2-XX)

  • Test plan – to identify the applicable testing and assist in choosing the appropriate routes for compliances.