BS EN ISO 11978:2017+A1:2020 - Ophthalmic Optics: Contact Lenses and Care Products Labelling

In the ever-evolving world of ophthalmic optics, ensuring the safety and efficacy of contact lenses and their care products is paramount. The BS EN ISO 11978:2017+A1:2020 standard is a comprehensive guideline that addresses the critical aspect of labelling for contact lenses and their associated care products. This standard is essential for manufacturers, healthcare professionals, and regulatory bodies involved in the ophthalmic industry.

Overview of the Standard

The BS EN ISO 11978:2017+A1:2020 standard provides detailed specifications for the labelling of contact lenses and contact lens care products. Released on October 26, 2020, this standard ensures that all relevant information is clearly communicated to both professionals and consumers, enhancing the safety and usability of these products.

Key Features

• Standard Number: BS EN ISO 11978:2017+A1:2020
• Pages: 22
• ISBN: 978 0 539 12099 8
• Status: Standard

Importance of Labelling in Ophthalmic Optics

Labelling is a critical component in the ophthalmic optics industry. It serves as a bridge between the manufacturer and the end-user, providing essential information about the product's use, safety, and maintenance. Proper labelling helps in:

• Ensuring Safety: By providing clear instructions and warnings, labelling helps prevent misuse and potential harm.
• Enhancing Usability: Detailed labelling ensures that users can easily understand how to use and care for their contact lenses, leading to a better user experience.
• Regulatory Compliance: Adhering to labelling standards is crucial for meeting regulatory requirements and maintaining market access.

Who Should Use This Standard?

The BS EN ISO 11978:2017+A1:2020 standard is designed for a wide range of stakeholders in the ophthalmic optics industry, including:

• Manufacturers: To ensure their products meet international labelling standards.
• Healthcare Professionals: To provide accurate information to patients and ensure safe product use.
• Regulatory Bodies: To assess compliance with labelling requirements.

Benefits of Adopting the Standard

Adopting the BS EN ISO 11978:2017+A1:2020 standard offers numerous benefits, including:

• Improved Safety: By ensuring that all necessary information is available to users, the risk of misuse is significantly reduced.
• Enhanced Consumer Confidence: Products that adhere to international standards are more likely to be trusted by consumers.
• Market Access: Compliance with international standards is often a prerequisite for entering global markets.

Detailed Content of the Standard

The standard spans 22 pages and covers a wide range of topics related to the labelling of contact lenses and care products. It includes:

• General Labelling Requirements: Guidelines on the information that must be included on product labels.
• Specific Labelling Instructions: Detailed instructions for different types of contact lenses and care products.
• Symbols and Pictograms: Standardized symbols to ensure universal understanding.
• Language Requirements: Recommendations on language use to ensure clarity and accessibility.

Conclusion

The BS EN ISO 11978:2017+A1:2020 standard is an indispensable resource for anyone involved in the production, distribution, or regulation of contact lenses and their care products. By providing clear and comprehensive guidelines for labelling, this standard helps ensure the safety, efficacy, and accessibility of ophthalmic products worldwide. Whether you are a manufacturer looking to comply with international standards, a healthcare professional seeking to provide the best care for your patients, or a regulatory body ensuring product safety, this standard is an essential tool in your arsenal.

BS EN ISO 11978:2017+A1:2020

This standard BS EN ISO 11978:2017+A1:2020 Ophthalmic optics. Contact lenses and contact lens care products. Labelling is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.

This document does not specify the format in which such information shall be provided.