ISO 12867:2010 PDF

Name: ISO 12867:2010 — Ophthalmic instruments — Trial frames
SKU: ISO 12867:2010
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Ophthalmic instruments — Trial frames

Название (английский):

ISO 12867:2010

Ophthalmic instruments — Trial frames

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 17 мая 2010 г.
Издание:: ISO IS 12867 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 12867:2010, together with ISO 15004‑1, specifies minimum requirements and test methods for trial frames for holding trial case lenses, complying with ISO 9801, in front of a subject's eyes in order to assess visual acuity and facilitate optical correction of vision. ISO 12867:2010 is applicable to lens holders mounted on headbands, bracket-mounted frames and frames mounted in the manner of spectacles with supports on the ears and the bridge of the nose. It is applicable to all types of trial frame, including half-eye and rotating lens holders. ISO 12867:2010 takes precedence over ISO 15004‑1, if differences exist.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 12867:2010 specifies minimum requirements and test methods for trial frames used in ophthalmic assessments. Together with ISO 15004‑1, it defines how trial frames should hold trial case lenses (ISO 9801) in front of a subject’s eyes to assess visual acuity and facilitate optical correction. The standard applies to headband-mounted, bracket-mounted and spectacle‑style trial frames, including half‑eye and rotating lens holders, and takes precedence over ISO 15004‑1 where differences exist.

Key topics and technical requirements

Lens holder design

Each lens holder must retain a combination of at least three lenses, each in separate compartments along the optical axis.
Lens axes must be parallel within 2.5° and coincide within a 1 mm tolerance circle when ISO 9801 trial lenses are fitted.
Lateral/axial lens movement limited to ±0.2 mm from centre.

Interpupillary distance (IPD)

Adjustable IPD ranges specified: 55–75 mm (full/reduced aperture) and 59–67 mm (half‑eye).

Optical alignment and rotation

Lens rotation of at least 180° per lens.
Geometrical axes of lens holders must be parallel within 2° and relative axial displacement ≤ 0.5 mm.
Axis scale indicating cylinder axis and prism base must extend to ≥180° with divisions ≤ 5°, increasing anticlockwise per ISO 8429.

Mechanical and material requirements

Vertex distance and lens height adjustable via the bridge piece.
No hazardous sharp edges; materials in contact with skin must be non‑toxic, non‑allergenic and non‑corrosive (or appropriately treated).

Marking and documentation

Frames must be permanently marked with manufacturer/supplier name and supplied with instructions for use, including disinfection and model identification.

Test methods

Type tests for parallelism and alignment; Annex A gives examples using an autocollimation telescope or laser methods.

Applications and users

ISO 12867:2010 is essential for:

Manufacturers and designers of trial frames to ensure compliant mechanical and optical specifications.

Quality assurance and testing labs performing type tests and acceptance checks.

Optometrists and ophthalmologists selecting and using trial frames for refraction and clinical assessments.

Procurement and regulatory bodies evaluating conformity for clinical equipment purchasing and certification.

Repair and maintenance services, which must follow disinfection and safety guidance.

Related standards

ISO 9801 - Trial case lenses (compatibility)

ISO 15004‑1 - General ophthalmic instrument requirements (ISO 12867 takes precedence if conflicts occur)

ISO 8429 - Graduated dial scales (axis scale direction)

ISO 10341 - Refractor heads (not covered by ISO 12867)

Keywords: ISO 12867:2010, trial frames, ophthalmic instruments, trial case lenses, interpupillary distance, lens holders, ISO 9801, trial frame testing.

ISO 12867:2010 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

SIST EN ISO 15004-1:2021

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

SIST EN ISO 9801:2010

Ophthalmic instruments - Trial case lenses (ISO 9801:2009)

SIST EN ISO 8429:2000

Optics and optical instruments - Ophthalmology - Graduated dial scale (ISO 8429:1986)

SIST EN ISO 12867:2010

Ophthalmic instruments - Trial frames (ISO 12867:2010)

BS EN ISO 10341:2012

Ophthalmic instruments. Refractor heads.