CSA Group Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications ISO/TR 22979:2017

Description
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.
  • Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications - ISO/TR 22979:2017 - CSA Group
    CSA Group
Description
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

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Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications - ISO/TR 22979:2017 - CSA Group
CSA Group
Toronto, Ontario, Canada
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TR 22979:2017
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications ISO/TR 22979:2017
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

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  CSA Group
Product Category Standards and Technical Documents
Product Number ISO/TR 22979:2017
Product Name Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
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