ISO 8612:2009 PDF

Ophthalmic instruments — Tonometers

Название (английский):

ISO 8612:2009

Ophthalmic instruments — Tonometers

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 29 сентября 2009 г.
Издание:: ISO IS 8612 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 8612:2009, together with ISO 15004-1, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP). ISO 8612:2009 takes precedence over ISO 15004-1, if differences exist.

Технические детали

Технический комитет: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
SKU: ISO 8612:2009

Abstract

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–

Overview

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–

ISO 8612:2009 PDF

Технические детали

Abstract

Overview

Key Topics and Requirements

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Abstract

Overview

Key Topics and Requirements

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