ISO 18369-1:2017
Current
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
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| Committee |
ISO/TC 172/SC 7
|
| DevelopmentNote |
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)
|
| DocumentType |
Standard
|
| Pages |
68
|
| ProductNote |
THIS STANDARD ALSO HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH FOR THE YEAR 2017.
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IS/ISO 18369 : Part 1 : 2017 | Identical |
| I.S. EN ISO 18369-1:2017&LC:2018 | Identical |
| I.S. EN ISO 18369-1:2017 | Identical |
| DIN EN ISO 18369-1:2016-06 (Draft) | Identical |
| SN EN ISO 18369-1:2018 | Identical |
| UNI EN ISO 18369-1 : 2009 | Identical |
| SS-EN ISO 18369-1:2017 | Identical |
| ONORM EN ISO 18369-1 : 2018 | Identical |
| DIN EN ISO 18369-1:2018-04 | Identical |
| UNI EN ISO 18369-1:2018 | Identical |
| PN EN ISO 18369-1 : 2017 | Identical |
| NF EN ISO 18369-1 : 2017 | Identical |
| UNE-EN ISO 18369-1:2018 | Identical |
| BS EN ISO 18369-1:2017 | Identical |
| NEN EN ISO 18369-1 : 2017 + COR 2018 | Identical |
| BIS IS/ISO 18369-1 : 2006(R2017) | Identical |
| UNE-EN ISO 18369-1:2007 | Identical |
| EN ISO 18369-1:2017 | Identical |
| NBN EN ISO 18369-1 : 2006 AMD 1 2009 | Identical |
| NS EN ISO 18369-1 : 2017 | Identical |
| 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 |
| 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 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 |
| 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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