SIST EN ISO 18369-3:2017

Name: SIST EN ISO 18369-3:2017 — Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)
SKU: SIST EN ISO 18369-3:2017
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Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)

Название (английский):

Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 47
Дата публикации:: 18 октября 2017 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

Тип поставки:

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Срок поставки:8 раб. дн. (перевод)

Цена:84 600 ₽

Описание (английский):

ISO 18369-3:2017 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369‑2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections and determination of spectral transmittance. This document also specifies the equilibrating solution and standard saline solution for testing of contact lenses.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 18369-3:2017 - "Ophthalmic optics - Contact lenses - Part 3: Measurement methods" (ISO 18369-3:2017) defines standardized laboratory and inspection methods for measuring the physical and optical properties of finished contact lenses. Adopted by CEN, this second edition (2017) supersedes the 2006 version and is intended for testing laboratories, manufacturers, suppliers and regulators involved in contact lens quality control and compliance.

Key topics and requirements

Scope of measurement: Methods for determining key contact lens parameters specified in ISO 18369‑2, including

Radius of curvature (optical spherometry, ophthalmometer; sagittal depth methods for hydrogels)
Label back vertex power (focimeter specifications, calibration, measurements for rigid and hydrogel lenses)
Diameter and zone widths
Thickness (dial gauge and low‑force mechanical gauge methods)
Edge inspection, inclusions and surface imperfections
Spectral transmittance (instrument and test conditions)

Equilibration and test solution: Specifies the equilibrating solution and a standard saline solution formulation and preparation for conditioning lenses prior to testing.

Measurement performance: Methods should achieve repeatability and reproducibility (R&R) such that R&R ≤ 30% of the allowed tolerance range. Lenses must be equilibrated until measured parameters are stable within the method’s capability.

Ancillary requirements: Focimeter calibration, specific temperature considerations during equilibration and measurement, and documentation of the equilibration procedure in test reports.

Informative annexes: Additional measurement techniques and guidance are provided (e.g., interferometry for rigid lens curvature, Moiré/Hartmann methods for soft lenses, ophthalmometer use, and focimeter paddles).

Applications and users

Contact lens manufacturers: Routine production quality control, specification verification and incoming inspection.

Testing and calibration laboratories: Accredited testing against standardized methods for compliance and certification.

Suppliers and distributors: Verification of labelling claims (back vertex power, diameter, etc.) and product acceptance testing.

Regulatory bodies and conformity assessors: Objective, repeatable methods to demonstrate compliance with product standards and safety requirements.

Research and development: Comparing materials and designs using standardized measurement protocols (radius, thickness, transmittance).

Related standards

ISO 18369-1:2017 - Vocabulary and labelling (referenced for terms)

ISO 18369-2 - Contact lens specifications (parameters measured by Part 3)

ISO 9342-1 and ISO 3696 - Normative references for focimeter test lenses and water quality for test solutions

EN ISO 18369-3:2017 is essential for anyone involved in the measurement, quality assurance and regulatory compliance of contact lenses, ensuring consistent, traceable and internationally harmonized test methods.

SIST EN ISO 18369-3:2017

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

ISO 18369-3:2017

Ophthalmic optics — Contact lenses — Part 3: Measurement methods

ISO 18369-1:2017

Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labell…

ISO 18369-2:2017

Ophthalmic optics — Contact lenses — Part 2: Tolerances

SIST EN ISO 9342-1:2023

Optics and optical instruments - Test lenses for calibration of focimeters - Part 1: Reference lenses for foc…

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)