Ophthalmic instruments — Perimeters — Amendment 1
Ophthalmic instruments — Perimeters — Amendment 1
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ISO 12866:1999/Amd 1:2008 is an important amendment to the international standard governing ophthalmic instruments known as perimeters. These instruments are critical in assessing visual fields for eye care diagnostics and monitoring. The amendment focuses on updating normative references, enhancing requirements for normative databases, and clarifying documentation accompanying the instruments. Developed by ISO Technical Committee ISO/TC 172 (Optics and photonics), Subcommittee SC 7 (Ophthalmic optics and instruments), this updated standard ensures the safety, reliability, and accuracy of perimeters in clinical and research settings.
Normative Reference Updates The amendment updates references to key standards:
Age-Specific Normal Value Comparison Perimeters must now compare each test location's result to age-specific normative data during routine use. This allows for more personalized and accurate interpretation of visual field results based on patient age.
Version Control for Normative Databases Manufacturers are required to specify the version number and issue date of the normative database tables. Printouts must include these identifiers, ensuring traceability and consistency in clinical records.
User Notification on Updates When new versions of normative value tables are implemented via software or other means, users must be notified. This maintains transparency and aids clinicians in understanding any changes in test interpretation.
Documentation Requirements Improved guidance on documents accompanying perimeters includes:
Minimum Requirements for Normative Databases (Annex C) The amendment specifies detailed criteria for normative databases, including:
ISO 12866:1999/Amd 1:2008 applies to all manufacturers, designers, and users of perimeter ophthalmic instruments used in:
Clinical Eye Examinations Screening and monitoring of visual fields to diagnose glaucoma, retinal diseases, and neurological disorders.
Research and Epidemiological Studies Generating standardized, comparable visual field data using robust normative databases.
Medical Device Regulation Providing frameworks for conformity, safety, and performance testing required for medical device approvals.
Training and Quality Assurance Standardized instructions and examination protocols facilitate consistent training and reduce operator variability.
This amendment enhances the reliability and clinical relevance of perimeter test outcomes by ensuring normative datasets are scientifically sound and that instruments meet updated electrical and safety requirements.
By adhering to ISO 12866:1999/Amd 1:2008, manufacturers and clinicians ensure perimeters deliver safe, precise, and clinically meaningful visual field assessments, supporting better patient outcomes in ophthalmic care.
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