Overview - What ISO 16971-1:2024 covers
ISO 16971-1:2024 is the first part of an international standard that defines requirements for optical coherence tomography (OCT) instruments intended to image and measure biological tissue of the posterior segment of the human eye (for example, the retina and optic nerve head). The document specifies the characteristics and minimum performance requirements for ophthalmic OCT systems, and describes type tests and verification procedures to confirm that an instrument qualifies as an OCT system under this standard. This edition revises ISO 16971:2015 and clarifies performance parameters, image presentation, data exchange (DICOM required), and manufacturer information.
Key technical topics and requirements
- Terminology and symbols: Definitions for A-scan, B-scan, en-face images, OCTA terms, anatomy and data processing vocabulary.
- Optical and signal properties: Requirements for transverse and axial optical resolution, axial range, angular field of view, sensitivity and axial signal roll-off.
- Construction and function: Optical specifications, tolerance requirements, co-alignment of fundus images with OCT scans, and light hazard protection in line with ISO 15004 and IEC 60825.
- Analysis and presentation: Standards for presentation of structural OCT images, retinal thickness measurement, reference databases and required metadata.
- Data exchange and interoperability: Minimum data exchange requirements with DICOM (NEMA PS3/ISO 12052) mandated for interoperability.
- Recommended test methods: Measurement setups and test procedures (resolution, sensitivity, axial roll-off, co-alignment methods including en-face and line-scan techniques).
- Manufacturer information: Required documentation - warnings, maintenance, imaging parameters, acquisition modes, measurement algorithms and data-exchange details.
Practical applications - who uses ISO 16971-1:2024
- OCT device manufacturers: for design, performance specification, conformance testing, and regulatory submissions.
- Clinical engineers and biomedical test labs: to verify device performance and safety according to standard test methods.
- Regulatory authorities and notified bodies: as a reference for essential performance and safety during device approval.
- Hospitals, eye clinics and procurement teams: to compare OCT systems, ensure interoperability (DICOM), and specify minimum features.
- Researchers and developers: for consistent terminology, measurement methods and data formats when developing algorithms, OCTA methods or normative databases.
Related standards
- ISO 15004-1 / ISO 15004-2 - ophthalmic instrument requirements and light hazard protection
- IEC 60601-1 - medical electrical safety and essential performance
- IEC 60825-1 - laser safety classification and requirements
- NEMA PS3 / DICOM (ISO 12052) - medical image data exchange and interoperability
Keywords: ISO 16971-1:2024, optical coherence tomography, OCT, posterior segment, retina, ophthalmic instruments, DICOM, performance requirements, test methods, safety.