SIST EN ISO 8612:2010 PDF

Ophthalmic instruments - Tonometers (ISO 8612:2009)

Название (английский):

SIST EN ISO 8612:2010

Ophthalmic instruments - Tonometers (ISO 8612:2009)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 21
Дата публикации:: 16 декабря 2009 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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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

SKU: SIST EN ISO 8612:2010

Abstract

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

Overview

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

SIST EN ISO 8612:2010 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

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