ISO 8612:2009 PDF

Overview

ISO 8612:2009 - Ophthalmic instruments - Tonometers defines minimum design and testing requirements for tonometers intended for routine clinical estimation of intraocular pressure (IOP). Applied together with ISO 15004-1, this International Standard establishes how manufacturers must demonstrate design compliance and verify individual instruments. Where differences exist, ISO 8612:2009 takes precedence over ISO 15004-1. Normative annexes provide the reference tonometer specifications (Annex A) and design compliance testing procedures (Annex B).

Key Topics and Requirements

• Scope and purpose: Specifies requirements for tonometers used to estimate IOP in clinical settings; recognizes that true IOP cannot be measured invasively and provides alternative reference methods.
• Design compliance testing: Manufacturers must show that test tonometer readings agree with a reference tonometer per defined tolerances. Acceptance is based on paired differences - not more than 5% of paired differences in each pressure range may exceed the tolerance.
• Performance tolerances and sample size:
  • IOP ranges: 7–16 mmHg, >16–