BS EN 80601-2-58:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
EN 60065:2002 Audio, video and similar electronic apparatus - Safety requirements (Incorporating Corrigendum August 2007; Incorporates Amendment A12: 2011; Remains Current)
EN 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 (Incorporating corrigendum March 2010)
EN 60601-2-2 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 (Incorporates Amendment A11: 2011)
EN 60825-1 Safety of laser products - Part 1: Equipment classification and requirements*， 2019-03-01 Update
EN 60950-1 Information technology equipment - Safety Part 1: General requirements Incorporates Amendment A1: 2010
EN 61847 Ultrasonics - Surgical Systems Measurement and Declaration of the Basic Output Characteristics
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
EN ISO 15004-2:2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
EN ISO 15752:2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
IEC 60601-2-2 Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessori*， 2023-02-21 Update
IEC 60825-1 Interpretation sheet 2 - Safety of laser products - Part 1: Equipment classification and requirements*， 2017-12-19 Update
IEC 60950-1 Information technology equipment - Safety - Part 1: General requirements*， 2023-12-23 Update
IEC 61847 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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 15004-2:2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
ISO 15752:2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN 80601-2-58:2015 history
2019BS EN 80601-2-58:2015+A1:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2015BS EN 80601-2-58:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2009BS EN 80601-2-58:2009+A11:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2009BS EN 80601-2-58:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery