IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT@ hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
IEC 80601-2-58:2014 Referenced Document
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
IEC 80601-2-58:2014 history
0000 IEC 80601-2-58:2024 RLV
2016IEC 80601-2-58:2014/AMD1:2016 Amendment 1 - Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2016IEC 80601-2-58:2016 Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique (Edition 2.1; Consolidated
2014IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2008IEC 80601-2-58:2008 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery