SIST EN ISO 10942:2022 PDF

Name: SIST EN ISO 10942:2022 — Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
SKU: SIST EN ISO 10942:2022
Price: 60.09 EUR
Availability: InStock

Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)

Название (английский):

SIST EN ISO 10942:2022

Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 15 марта 2022 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version195 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:3 раб. дн. (перевод)

Цена:195 €

Описание (английский):

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Abstract

Overview

Key topics and technical requirements

Classification: Two groups - Group A (full requirements) and Group B (reduced requirements).
Optical performance: Specifies viewing lens power steps and field requirements. Examples include:
- Field of view: ≥ 3° (Group A), ≥ 2.5° (Group B).
- Field of illumination at maximum aperture: ≥ 9° (Group A), ≥ 7° (Group B).
- Viewing system diameter: ≥ 3 mm (Group A), ≥ 2.5 mm (Group B).
Viewing lenses and controls: Indexed lens disc with directional color coding (positive in black/green, negative in red) and indexing stops; left‑ and right‑hand operation required.
Illumination system: Defocused beam must be homogeneous and achromatic. Group A requires luminous flux adjustable from maximum down to 10% of maximum, at least two aperture stops (full and reduced) and a red‑free filter; additional filters/graticules optional.
Optical accuracy and centration: Tolerances for combined refractive power and lens centration are specified (tighter tolerances at low powers, larger at high powers); see the standard for the full table of values.
Safety - optical radiation hazard: Direct ophthalmoscopes must meet requirements in ISO 15004‑2 (replaces certain clauses of IEC 60601‑1).
Test methods: Type tests only. Measurement devices must have accuracy better than 10% of the smallest value measured. Example methods: refractive power measured with a focimeter (ISO 8598‑1); field of view measured with the instrument back surface 12 mm from a pin‑hole light source.

Applications and users

Who uses EN ISO 10942:2022:

Ophthalmic instrument manufacturers (design, production QA, conformity).
Independent test laboratories and notified bodies (type testing).
Clinical engineers and service technicians (verification and maintenance).
Regulatory and procurement teams evaluating device compliance and safety. Practical uses: product specification, performance verification, lab test protocols, risk/safety assessment (light hazards), and labeling/marking guidance.

Related standards

ISO 15004‑1 - General requirements for ophthalmic instruments
ISO 15004‑2 - Light hazard protection for ophthalmic instruments
IEC 60601‑1 - Medical electrical equipment (referenced)
ISO 8598‑1 - Focimeter specification for refractive power measurements

For implementation, consult the full EN ISO 10942:2022 text for complete tables, test procedures and marking requirements.

Технические детали

SKU: SIST EN ISO 10942:2022

Главная

Каталог

ISO 10942:2022

Действующий

Ophthalmic instruments — Direct ophthalmoscopes

Overview ISO 10942:2022 specifies minimum requirements and type test methods for hand-held direct ophthalmoscopes used for direct examination of the eye fundus. Issued as the third edition, this ISO…

6 · PDF

25 €

ISO 10942:2006

Отменён

Ophthalmic instruments — Direct ophthalmoscopes

7 · PDF

25 €

SIST EN ISO 15004-1:2021

Действующий

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable…

Overview EN ISO 15004-1:2020 - "Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments" defines the core safety, de…

14 · PDF

60 €

SIST EN ISO 15004-2:2025

Действующий

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 150…

Overview EN ISO 15004-2:2024 - Ophthalmic instruments: Light hazard protection defines fundamental requirements and test methods for optical radiation safety of ophthalmic instruments that direct lig…

65 · PDF

115 €

IEC 60601-1:2005

Действующий

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Overview IEC 60601-1:2005 (Consolidated Edition 3.1, with Amendment 1) is the international safety standard for medical electrical equipment, defining the general requirements for basic safety and es…

10 · PDF

619 €

SIST EN ISO 8598-1:2014

Действующий

Optics and optical instruments - Focimeters - Part 1: General purpose instruments used for measuring spectacl…

Overview EN ISO 8598-1:2014 - Optics and optical instruments - Focimeters - Part 1: General purpose instruments defines requirements and test methods for general-purpose focimeters used to measure sp…

35 · PDF

89 €

SIST EN ISO 10942:2022 PDF

Abstract

Overview

Похожие стандарты

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 10942:2022

Ophthalmic instruments — Direct ophthalmoscopes

ISO 10942:2006

Ophthalmic instruments — Direct ophthalmoscopes

SIST EN ISO 15004-1:2021

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable…

SIST EN ISO 15004-2:2025

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 150…

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SIST EN ISO 8598-1:2014

Optics and optical instruments - Focimeters - Part 1: General purpose instruments used for measuring spectacl…