IEC 80601-2-58:2024

Overview

IEC 80601-2-58:2024 (published as a joint ISO/IEC double-logo standard) defines particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices used in ophthalmic surgery, including associated accessories and handpieces that connect to this medical electrical equipment (ME EQUIPMENT). It replaces the 2014 edition (and its 2016 amendment) and constitutes a technical revision aligned with amendments to the IEC 60601-1 series.

Key topics and technical requirements

• Scope and applicability: Requirements apply to ME EQUIPMENT and ME SYSTEMS where relevant; hazards inherent to intended physiological function are generally excluded except where cited in IEC 60601-1 amendments.
• Alignment with IEC 60601-1 series: Updated to reflect changes in IEC 60601-1:2005 and its amendments, ensuring consistency with core medical electrical safety requirements.
• Updated normative references: Collateral and particular standard references have been revised to reflect current editions and amendments.
• New requirements
  • Particulate matter from applied parts - new requirement addressing particulate emissions from patient-contact parts (201.9.5.101).
  • Shadow light method - added test method for optical/illumination assessment (201.12.1.101.7).
  • EMC test conditions clarification - clarified test conditions for electromagnetic compatibility (202.7.1.2).
• Documentation and risk management: Compliance is expected to be recorded in the device’s risk management file; particular standards take precedence over general IEC 60601-1 clauses where specified.
• Regulatory alignment: New Annex BB maps relevant general safety and performance requirements of EU Regulation (EU) 2017/745 (MDR).
• Editorial changes: Updated symbol references and deletion of the liquefaction fragmentation lens removal method.

Applications and who should use this standard

IEC 80601-2-58:2024 is essential for:

• Medical device manufacturers designing or producing phacoemulsification, lens removal, or vitrectomy consoles, handpieces and accessories.
• Design and test engineers performing safety, EMC, optical and particulate testing.
• Regulatory, quality and compliance teams preparing technical documentation for CE marking, MDR conformity, or other market approvals.
• Notified bodies and test laboratories assessing conformity with IEC 60601 series and device-specific requirements.
• Clinical engineering and hospital procurement teams evaluating device safety and performance specifications.

Related standards

• Core reference: IEC 60601-1 (and its amendments) - general requirements for basic safety and essential performance of medical electrical equipment.
• Collateral standards (e.g., IEC 60601-1-2 for EMC) as modified by this particular standard.
• Annex BB for alignment with EU 2017/745 (MDR).

Keywords: IEC 80601-2-58:2024, lens removal devices, vitrectomy devices, ophthalmic surgery, medical electrical equipment, safety, essential performance, particulate matter, shadow light method, EMC, EU MDR.