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I.S. EN ISO 18369-1:2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01)
Available format(s)

Hardcopy , PDF

Superseded date

07-16-2020

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Classification of contact lens materials
Annex A (informative) - Specification of rigid contact lenses
Annex B (informative) - Specification of soft contact lenses
Bibliography
Alphabetical index of terms

Describes the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses.

DevelopmentNote
Supersedes I.S. EN ISO 8320-1, I.S. EN ISO 8320-2 and I.S. EN ISO 11539. (10/2006) Supersedes I.S. EN ISO 8321-1 & I.S. EN ISO 8321-2. (10/2017)
DocumentType
Standard
Pages
82
ProductNote
THIS STANDARD IS IDENTICAL TO EN ISO 18369-1:2017
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
ISO 13666:2012 Ophthalmic optics Spectacle lenses Vocabulary
ISO 18369-2:2017 Ophthalmic optics — Contact lenses — Part 2: Tolerances
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 18369-3:2017 Ophthalmic optics — Contact lenses — Part 3: Measurement methods
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO/TS 19979:2014 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 18369-4:2017 Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 20473:2007 Optics and photonics — Spectral bands
ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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Hardcopy - English
PDF - English
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