ISO 12866:1999/Amd 1:2008

Overview

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.

Key Topics

• 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.

Applications

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.

Related Standards

• ISO 15004-1:2006 – Ophthalmic instruments - Fundamental requirements and test methods (Part 1: General requirements).
• IEC 60601-1:2005 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• ISO 8596 – Optics and optical instruments - Visual acuity testing methods.
• ISO 12866:1999 – Base standard for ophthalmic perimeters before Amendment 1.

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.