SIST EN ISO 8612:2010 PDF

Overview

EN ISO 8612:2009 - Ophthalmic instruments - Tonometers (ISO 8612:2009) is a CEN-endorsed international standard that specifies minimum design, testing and verification requirements for tonometers used in routine clinical estimation of intraocular pressure (IOP). It is intended to ensure reliable, repeatable IOP readings and to harmonize certification and factory verification for ophthalmic tonometers. Where differences exist, EN ISO 8612:2009 takes precedence over ISO 15004-1.

Key topics and technical requirements

• Scope and normative references: Works together with ISO 15004-1 and references IEC 60601-1 for electrical safety.
• Measurement range: Tonometers must measure across a clinical range from 7 mmHg to 50 mmHg; readings outside this range must show “low” or “high” indicators if not numerically displayed.
• Accuracy tolerances: Design compliance requires that paired differences versus a reference tonometer meet a tolerance of ±5.0 mmHg across the specified IOP ranges; statistical pass criterion: no more than 5% of paired differences exceed tolerance.
• Sample size for certification: Minimum 40 eyes per IOP range during design compliance testing.
• Reference tonometer specification:
  • Mechanical-optical applanation type with applanation area diameter 3.06 mm ± 0.02 mm.
  • Contact surface flatness over central 4 mm: **peak-to-valley