Overview
ISO 16971:2015 - "Ophthalmic instruments - Optical coherence tomograph for the posterior segment of the human eye" defines terminology, minimum performance requirements, and test methods for optical coherence tomography (OCT) instruments and systems intended to image and measure biological tissue of the posterior segment (retina, RPE) of the human eye. The standard establishes a consistent framework to evaluate OCT performance, support device comparison, and improve clinical interoperability.
Key topics and technical requirements
- Scope and definitions: Clarifies OCT and related ophthalmic terms used for posterior-segment imaging.
- Retinal thickness: Measurement must assume refractive indices in the range n = 1.33 to 1.39; standardized presentation (recommended continuous grey scale with keys) is defined for comparability.
- Image quality parameters: Manufacturers must provide X, Y, Z resolution definitions and measurement methods, and signal-to-noise ratio (SNR) as a function of depth (Z). Axial resolution and SNR must be specified.
- Angular field of view (FOV) tolerance: ±5%.
- Depth scaling accuracy: Measurement accuracy of test targets ≤ ±3%.
- Calibration / co-alignment: If a fundus image is provided, marker-to-scan co-alignment must be within ±100 µm at the center of the FOV (specified ambient temperature, e.g., 21 °C ± 2 °C).
- Normative database: Recommended age-specific normal mean and distribution; versioning, size and age range must be specified (minimum requirements in Annex A). Printouts should state the database version.
- Data export: All diagnostic images must be exportable (examples: PDF, TIFF, JPG, DICOM).
- Light hazard & safety: Conformance to ISO 15004-2 with specified aperture guidance (3.5 mm vs. 1 mm where noted).
- Test methods: Type-test procedures and a reference test device are specified (e.g., glass thickness ~1 mm with known refractive index, ND filter to prevent saturation).
Applications and who uses it
- Medical device manufacturers - design, performance claims, labeling and compliance testing for posterior-segment OCT systems.
- Test laboratories & conformity assessors - perform type tests and verify device capabilities against ISO 16971:2015.
- Regulatory bodies & procurement - assess interoperability, safety and minimum performance for approval and purchasing.
- Clinicians & clinical researchers - understand measurement limitations, image export, and normative comparisons for diagnosis and longitudinal studies.
Related standards
Keywords: ISO 16971:2015, OCT, optical coherence tomography, posterior segment, retinal thickness, axial resolution, SNR, normative database, data export, ophthalmic instruments.