Name: ISO 12866:1999/Amd 1:2008 — Ophthalmic instruments — Perimeters — Amendment 1
SKU: ISO 12866:1999/Amd 1:2008
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ISO 12866:1999/Amd 1:2008 PDF — Ophthalmic instruments — Perimeters — Amendment 1 — GOST Standards

Normative Reference Updates The amendment updates references to key standards:
- ISO 15004-1:2006 for fundamental requirements and test methods for ophthalmic instruments.
- IEC 60601-1:2005 for general safety and essential performance of medical electrical equipment. These updates help align perimeter testing with the latest safety protocols and performance benchmarks.
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:
- Manufacturer’s name and address.
- Confirmation of compliance with transport conditions.
- Additional documents per IEC 60601-1:2005.
- Specification of examination strategies to improve test reliability.
Minimum Requirements for Normative Databases (Annex C) The amendment specifies detailed criteria for normative databases, including:
- Inclusion criteria for healthy eyes covering visual acuity, refractive errors, and exclusion of pathological conditions.
- Requirements for perimetric test experience and methods for selecting the eye tested.
- Definitions for unreliable exams (fixation behavior, false responses).
- No exclusion of exams based solely on test results except when pathological criteria are met.
- Sample size minimums with at least 60 eyes, including diverse age groups to ensure robustness of normative data.

ISO 12866:1999/Amd 1:2008 PDF

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