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  • ISO 16971:2015

    Current The latest, up-to-date edition.

    Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  15-04-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.

    ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.

    ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 16971. (04/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 15004-1:2006 Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 12052:2017 Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
    ISO 32000-1:2008 Document management — Portable document format — Part 1: PDF 1.7
    ISO 10940:2009 Ophthalmic instruments — Fundus cameras
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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