What is IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products Labelling?

IS 18853 : 2024 Indian Standard which is identical to ISO 11978 : 2017 ‘Ophthalmic optics - Contact lenses and contact lens care products Labelling’ issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on the recommendation of the Ophthalmic Instruments and Appliances Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The main objective is to guarantee the safety and well-being of contact lens users by promoting communication between manufacturers and users regarding product characteristics, handling, use, and storage.

The guidelines also aim to facilitate global compatibility and regulatory compliance, ensuring that products can be safely distributed and used in various regions around the world. The key elements of this standard address both primary and secondary packaging for contact lenses and care products. It highlights that labels must contain legible text and symbols, ensuring that users can easily understand important product-related information. In addition, the standard emphasizes the importance of a contrast ratio between text and background for improved readability and visibility. Amendments introduced in 2020 specifically clarify guidelines to ensure that written information and symbols are readable under various conditions, including providing specifications for contrast ratios based on the RGB color model. The amendment aims to increase accessibility, especially for the visually impaired.

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Significance of IS 18853: 2024

The significance of IS 18853: 2024 lies in its ability to standardize Labelling for contact lenses and care products, ensuring uniformity across the industry. This coordination is critical to safety, especially in a field such as ophthalmic optics, where misuse of the product can lead to eye infection, discomfort, or permanent vision loss.

The clarity provided by this standard helps prevent misunderstandings that can arise from unclear Labelling, which provides detailed and understandable instructions on how to handle, store, and use contact lenses and related care products. The comprehensive nature of the standard also ensures that consumers are aware of the risks associated with the use of these products, such as potential eye infections, improper care techniques, or exposure to harmful substances.

Scope of IS 18853: 2024

IS 18853: 2024, based on ISO 11978: 2017 + AMD 1: 2020, outlines comprehensive guidelines for labelling contact lenses and their care products. It specifies essential labelling information, including manufacturer details, product description, intended use, wear schedule, sterilization methods, expiry dates, and storage instructions. The standard emphasizes legibility by setting requirements for text size, contrast, and text height to ensure readability, especially for users with visual impairments. These require BIS registration for gaining consumer confidence.

Product-specific details must also be included, such as lens parameters, package quantity, and intended use for contact lenses, and ingredients, sterilization methods, and usage instructions for care products. Additionally, it aligns labelling practices with national and international regulations while considering local legal requirements. The use of internationally recognized symbols is encouraged to convey instructions and warnings clearly and uniformly, in accordance with ISO 15223–1. Amendment 1 (2020) further enhances accessibility by refining guidelines for contrast and visibility between text and background to improve user experience.

Key Components of IS 18853: 2024

IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 ophthalmic optics - contact lenses and contact lens care products labelling consists of the following key components:

Manufacturer information: This includes the name, address, and contact details of the manufacturer or distributor.
Product identification and parameters: The labelling must provide clear identification of the product, including its specifications, type, and parameters such as lens curvature, diameter, and base curve.
Instructions for use: This section covers details about how the contact lens should be inserted, removed, and cleaned. It also includes important details on wear schedules, such as daily, weekly, or monthly usage.
Sterilization and expiry details: The method used to sterilize the lenses and care products must be clearly stated, along with their expiration dates.
Warnings and precautions: Labels must include any necessary safety warnings, including risks associated with wearing the lenses for extended periods, improper cleaning, or exposure to water.
Storage and handling: Instructions for proper storage and handling of both contact lenses and care products must be provided to ensure their efficacy and safety.
Contrast requirements: A critical component of the labelling guidelines is the requirement for legible text and symbols. These must meet minimum contrast standards to ensure that all users can easily read the information.

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Benefits of IS 18853: 2024

There are several benefits of IS 18853: 2024, the main includes:

Better safety and compliance: The standard ensures that all necessary information is provided, thereby reducing the risk of misuse and improving the safety of contact lens wearers. It helps manufacturers comply with international regulations, enabling smooth market access.
Improved accessibility: With clearer and more readable Labelling, consumers are better informed about how to use, store and care for their contact lenses. This is especially important for people who are visually impaired or older adults who may have trouble reading small print.
Standardization: Harmonization of labelling requirements ensures that there is consistency across the industry, making it easier for users to understand and compare products.
Increased consumer confidence: By following internationally recognized standards, manufacturers can increase consumer confidence in the quality and safety of their products. Having BIS certification also helps in this.

Impact of IS 18853: 2024 on Stakeholders

Manufacturers: Manufacturers are required to adopt standardized Labelling practices, to ensure that their products meet safety and regulatory standards. Compliance with IS 18853:2024 ISO 11978:2017 + AMD 1:2020 can enhance their marketability and customer trust.
Consumers: The standard directly benefits consumers by ensuring that they receive clear, accurate and useful information about the safe use of contact lenses and their associated care products.
Eye Care Professionals: Ophthalmologists, optometrists, and other eye care professionals rely on accurate Labelling to advise their patients on the proper use of contact lenses and related products. This standard helps streamline their work by providing uniform and consistent product specifications.
Regulatory bodies: Supports regulatory authorities in implementing standard safety protocols and ensuring products meet required health and safety standards.
Retailers: Retailers benefit from having access to products that are clearly labeled and according to international standards, which can reduce product returns and customer complaints.

Other Important Considerations

Global harmonization: IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 helps manufacturers ensure that their products comply with regulations in multiple countries, facilitating international trade.
Technological advancements: As technology in the contact lens industry evolves, the standard may need to be updated to include new product types, materials, or technologies. Regular updates and amendments will ensure that the standard remains relevant and effective.
Consumer education: Beyond labelling, educating consumers about the correct use and maintenance of contact lenses is crucial. Manufacturers and healthcare providers should work together to ensure that consumers are well-informed.
Sustainability: With growing environmental concerns, it is important to consider the sustainability of both the contact lenses and the care products. Future revisions of the standard may address environmental impact, encouraging eco-friendly practices in the production, packaging, and disposal of these products.

Conclusion

IS 18853:2024 ISO 11978:2017 + AMD 1:2020 plays a critical role in ensuring the safety, effectiveness, and accessibility of contact lenses and care products. By standardizing Labelling practices, the standard helps manufacturers communicate essential product information to consumers and eye care professionals, reducing risks of misuse and enhancing safety. The focus on legibility, clear instructions, and international compatibility strengthens consumer confidence and supports regulatory compliance globally. Furthermore, this standard facilitates global trade, aids in consumer education, and emphasizes the importance of sustainability in the ophthalmic optics industry. Overall, IS 18853:2024 improves both product safety and consumer understanding, benefiting all stakeholders involved, from manufacturers to end-users.

IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products Labelling

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