Overview
ISO 18369-1:2017, published by the International Organization for Standardization (ISO), is a key global standard in the field of ophthalmic optics specifically focused on contact lenses. This standard establishes the vocabulary, classification system, and labelling recommendations for contact lenses and contact lens care products. It defines terms related to the physical, chemical, and optical properties of contact lenses, their manufacture, and usage. The document also provides classifications of contact lens materials and guidance on specifying lens parameters for consistent labelling.
This 2017 edition replaces the earlier 2006 version with technical revisions and corrections, reflecting updates in terminology and classification relevant to modern contact lens technology, including rigid, soft, and composite lens types.
Key Topics
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Comprehensive Vocabulary: ISO 18369-1:2017 delineates precise definitions of terms used across the contact lens industry, such as rigid gas-permeable lenses, soft contact lenses, bifocal and multifocal lenses, and scleral lenses. It also identifies associated symbols and abbreviations to facilitate universal understanding and usage.
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Classification of Contact Lens Materials: The standard categorizes contact lenses primarily into rigid (including corneal and scleral lenses) and soft lenses, further detailing materials like hydrogels and gas-permeable polymers.
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Labeling Specifications: It provides recommendations for labelling contact lenses to clearly communicate critical specifications such as dioptre power, base curve, diameter, and material composition. This promotes safety, usability, and regulatory compliance.
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Parameters and Design Terms: The document defines essential contact lens parameters-like front vertex power, optic zone, centre thickness, and geometric centre-ensuring precision in design and measurement during manufacturing and fitting processes.
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Contact Lens Care Products: Terms related to cleaning, storing, and maintaining contact lenses are also standardized, covering accessories and solutions that ensure lens safety and performance post-manufacture.
Applications
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Manufacturers and Designers: ISO 18369-1 provides a standardized language for contact lens design and materials classification, facilitating consistent product development and innovation.
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Clinicians and Optometrists: The vocabulary and specifications enable eye care professionals to better understand lens features and communicate effectively about fitting, prescribing, and managing contact lenses for patients.
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Regulatory Bodies: The labelling guidance supports regulatory compliance in different countries by harmonizing product information and promoting transparent communication about lens specifications and care instructions.
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Researchers and Educators: It serves as an authoritative reference for scientific study and teaching related to contact lenses and ophthalmic optics.
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Contact Lens Care Industry: Standardized terminology and accessory definitions help manufacturers of cleaning solutions, cases, and handling devices to meet safety and performance criteria.
Related Standards
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ISO 18369 Series: ISO 18369-1:2017 is part one of the comprehensive ISO 18369 series, which covers various aspects of contact lens standards including measurement methods (Part 3), packaging, and care systems.
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ISO 13666: This standard is referenced within ISO 18369-1 for detailed optical terminology and measurement procedures pertinent to contact lens power and design.
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ISO/IEC Directives: The development and maintenance of this standard adhere to ISO/IEC directives ensuring rigorous consistency in editorial and procedural rules.
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Other Ophthalmic Standards: ISO 18369-1 complements other international standards focused on eye care devices, helping to establish a complete framework for quality and safety in ophthalmic optics.
ISO 18369-1:2017 is indispensable for maintaining clarity, safety, and innovation in the contact lens industry. By standardizing the vocabulary and classification systems as well as prescribing labelling protocols, it ensures that all stakeholders-manufacturers, healthcare providers, regulators, and users-operate with common understanding and meet stringent quality requirements. This fosters better patient outcomes through precise, safe contact lens products and care solutions worldwide.