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  • ISO 18369-1:2017

    Current The latest, up-to-date edition.

    Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  23-08-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 18369-1:2017 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This document also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 172/SC 7
    Development Note Supersedes ISO 8320-1, ISO 8320-2, ISO 8321-1, ISO 8321-2 and ISO 11539 (08/2006) Supersedes ISO/DIS 18369-1. (08/2017)
    Document Type Standard
    Product Note THIS STANDARD ALSO HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH FOR THE YEAR 2017.
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    04/30088797 DC : DRAFT APR 2004 ISO 18369 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS
    16/30348908 DC : 0 BS EN ISO 11986 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PRESERVATIVE UPTAKE AND RELEASE
    13/30266987 DC : 0 BS EN ISO 13212 - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE
    ISO 11978:2017 Ophthalmic optics — Contact lenses and contact lens care products — Labelling
    16/30310659 DC : 0 BS EN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES
    ISO 19045:2015 Ophthalmic optics — Contact lens care products — Method for evaluating Acanthamoeba encystment by contact lens care products
    I.S. EN ISO 18369-2:2017 OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017)
    I.S. EN ISO 11978:2017 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017)
    ISO 18369-4:2017 Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials
    BS EN ISO 18369-4:2017 Ophthalmic optics. Contact lenses Physicochemical properties of contact lens materials
    BS EN ISO 14730:2014 Ophthalmic optics. Contact lens care products. Antimicrobial preservative efficacy testing and guidance on determining discard date
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    BS EN ISO 9394:2012 Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes
    DIN EN ISO 11980:2013-03 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
    DIN EN ISO 11987:2012-11 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF SHELF-LIFE (ISO 11987:2012)
    I.S. EN ISO 18369-4:2017&LC:2018 OPHTHALMIC OPTICS - CONTACT LENSES - PART 4: PHYSICOCHEMICAL PROPERTIES OF CONTACT LENS MATERIALS (ISO 18369-4:2017, CORRECTED VERSION 2017-10-01)
    08/30138762 DC : DRAFT APR 2008 BS EN ISO 11980 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS
    ISO 18189:2016 Ophthalmic optics Contact lenses and contact lens care products Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
    PREN ISO 11978 : DRAFT 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO/DIS 11978:2013)
    ISO 19979:2018 Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
    EN ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
    EN ISO 11986:2017 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2017)
    DIN EN ISO 9394:2013-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    UNE-EN ISO 11980:2013 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
    I.S. EN ISO 11987:2012 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF SHELF-LIFE (ISO 11987:2012)
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    I.S. EN ISO 13212:2014 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR THE DETERMINATION OF SHELF-LIFE (ISO 13212:2014)
    I.S. EN ISO 9394:2012 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
    I.S. EN ISO 14730:2014 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014)
    I.S. EN ISO 11980:2012 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS (ISO 11980:2012)
    UNI EN ISO 13212 : 2014 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE
    BS ISO 19045:2015 Ophthalmic optics. Contact lens care products. Method for evaluating Acanthamoeba encystment by contact lens care products
    BS ISO 18259:2014 Ophthalmic optics. Contact lens care products. Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
    UNE-EN ISO 18369-2:2013 Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
    11/30243462 DC : 0 BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
    ISO 11981:2017 Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses
    04/30088803 DC : DRAFT APR 2004 ISO 18369-4 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 4: PHYSICOCHEMICAL PROPERTIES OF CONTACT LENS MATERIALS
    ISO 11986:2017 Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    BS EN ISO 11978:2017 Ophthalmic optics. Contact lenses and contact lens care products. Labelling
    ISO 18259:2014 Ophthalmic optics — Contact lens care products — Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
    I.S. EN ISO 11986:2017 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PRESERVATIVE UPTAKE AND RELEASE (ISO 11986:2017)
    BS EN ISO 18369-2:2017 Ophthalmic optics. Contact lenses Tolerances
    PD ISO/TS 19979:2014 Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
    ISO 18369-2:2017 Ophthalmic optics — Contact lenses — Part 2: Tolerances
    EN ISO 11978:2017 Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
    DIN EN ISO 14729:2011-01 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd.1:2010); German version EN ISO 14729:2001 + A1:2010
    DIN EN ISO 14730:2015-02 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014)
    UNE-EN ISO 11987:2013 Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012)
    BS EN ISO 13212:2014 Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf-life
    UNE-EN ISO 14729:2002 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses. (ISO 14729:2001)
    ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
    EN ISO 18369-3:2017 Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017, Corrected version 2017-10-01)
    I.S. EN ISO 14729:2001 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - MICROBIOLOGICAL REQUIREMENTS AND TEST METHODS FOR PRODUCTS AND REGIMENS FOR HYGIENIC MANAGEMENT OF CONTACT LENSES
    EN ISO 13212:2014 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
    UNI EN ISO 11987 : 2012 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF SHELF-LIFE
    UNI EN ISO 14730 : 2015 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE
    UNI EN ISO 9394 : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
    UNI EN ISO 11980 : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS
    UNE-EN ISO 11978:2018 Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
    14/30268874 DC : 0 BS ISO 18259 - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - METHOD TO ASSESS CONTACT LENS CARE PRODUCTS WITH CONTACT LENSES IN A LENS CASE, CHALLENGED WITH BACTERIAL AND FUNGAL ORGANISMS
    14/30296395 DC : 0 BS ISO 19045 - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - METHOD FOR EVALUATING ACANTHAMOEBA ENCYSTMENT BY CONTACT LENS CARE PRODUCTS
    17/30342704 DC : 0 BS EN ISO 11981 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PHYSICAL COMPATIBILITY OF CONTACT LENS CARE PRODUCTS WITH CONTACT LENSES
    12/30233857 DC : 0 BS PREN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES
    09/30193804 DC : 0 BS EN ISO 11986 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PRESERVATIVE UPTAKE AND RELEASE
    15/30266276 DC : 0 BS ISO 18189 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - CYTOTOXICITY TESTING OF CONTACT LENSES AND CONTACT LENS CARE SOLUTIONS
    BS ISO 18189:2016 Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
    I.S. EN ISO 11981:2017 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PHYSICAL COMPATIBILITY OF CONTACT LENS CARE PRODUCTS WITH CONTACT LENSES (ISO 11981:2017)
    EN ISO 18369-4:2017 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials (ISO 18369-4:2017, Corrected version 2017-10-01)
    ISO 18369-3:2017 Ophthalmic optics — Contact lenses — Part 3: Measurement methods
    DIN EN ISO 13212:2014-12 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO 13212:2014)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    BS EN ISO 14729 : 2001 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - MICROBIOLOGICAL REQUIREMENTS AND TEST METHODS FOR PRODUCTS AND REGIMENS FOR HYGIENIC MANAGEMENT OF CONTACT LENSES
    DIN EN ISO 9394 E : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
    ISO 13212:2014 Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life
    UNE-EN ISO 14730:2014 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    UNE-EN ISO 9394:2013 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    UNE-EN ISO 13212:2014 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
    ISO 11980:2012 Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
    BS EN ISO 11987:2012 Ophthalmic optics. Contact lenses. Determination of shelf-life
    ISO 11987:2012 Ophthalmic optics — Contact lenses — Determination of shelf-life
    EN ISO 14729:2001/A1:2010 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 1 (ISO 14729:2001/Amd 1:2010)
    EN ISO 11987:2012 Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012)
    EN ISO 14730:2014 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014)
    EN ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
    EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    EN ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    BS EN ISO 18369-3:2017 Ophthalmic optics. Contact lenses Measurement methods
    ISO/TS 19979:2014 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses
    17/30326683 DC : DRAFT SEP 2017 BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES
    13/30268148 DC : 0 BS EN ISO 11978 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING
    04/30082917 DC : DRAFT APR 2004 ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES
    PREN ISO 13212 : DRAFT 2013 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO/DIS 13212:2013)
    BS ISO 19979:2018 Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
    NF EN ISO 18369-4 : 2017 OPHTHALMIC OPTICS - CONTACT LENSES - PART 4: PHYSICOCHEMICAL PROPERTIES OF CONTACT LENS MATERIALS
    EN ISO 11981:2017 Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)
    I.S. EN ISO 18369-3:2017 OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS (ISO 18369-3:2017, CORRECTED VERSION 2017-10-01)
    BS EN ISO 11980:2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
    ISO 14730:2014 Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date

    Standards Referencing This Book - (Show below) - (Hide below)

    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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