ISO 16971:2015

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

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

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Referenced standards

IEC 60601-1:2005IEC 60825-1:2014IEC 62304:2006ISO 10940:2009ISO 10993-1:2009ISO 12052:2006ISO 13485:2003ISO 14155:2011ISO 14971:2007ISO 15004-1:2006ISO 32000-1:2008ISO/DIS 15004-2
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ISO 16971:2015

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

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

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.

Edition2015
Published Date2015
Published ByInternational Standardization Organisation
Page Count9