BS EN ISO 15798:2013+A1:2017

## BS EN ISO 15798:2013+A1:2017 - Ophthalmic ImplantsBS EN ISO 15798:2013+A1:2017 is the definitive standard for ophthalmic implants, providing a comprehensive framework to ensure the safety and performance of these critical medical devices. This standard, developed by the International Organization for Standardization (ISO), is an essential resource for any organization involved in the manufacture, supply, or use of ophthalmic implants.### Key Features and Benefits:- **Rigorous Safety Requirements**: The standard outlines stringent safety protocols and testing procedures to minimize the risk of complications or adverse events associated with ophthalmic implants.- **Improved Patient Outcomes**: By adhering to the standards set forth in BS EN ISO 15798:2013+A1:2017, manufacturers can develop ophthalmic implants that deliver superior clinical outcomes and enhanced patient satisfaction.- **Regulatory Compliance**: Conformance with this standard is often a prerequisite for the approval and marketing of ophthalmic implants in many jurisdictions, ensuring your products meet the necessary legal and regulatory requirements.- **Quality Assurance**: The standard provides a framework for implementing robust quality management systems, enabling manufacturers to consistently produce high-quality, reliable ophthalmic implants.- **Harmonized International Standards**: As an ISO standard, BS EN ISO 15798:2013+A1:2017 is recognized and accepted globally, facilitating international trade and collaboration within the medical device industry.### Comprehensive Scope:BS EN ISO 15798:2013+A1:2017 covers a wide range of ophthalmic implants, including:- Intraocular lenses (IOLs)- Corneal implants- Glaucoma drainage devices- Retinal implants- Other specialized ophthalmic implantsThe standard addresses all aspects of the product lifecycle, from design and development to manufacturing, packaging, sterilization, and post-market surveillance.### Technical Specifications:The standard outlines detailed technical requirements and test methods for ophthalmic implants, including:- Biocompatibility and toxicology- Mechanical and physical properties- Optical performance- Sterilization and packaging- Labeling and instructions for use- Clinical evaluation and post-market surveillanceBy adhering to these technical specifications, manufacturers can ensure their ophthalmic implants meet the highest standards of safety, quality, and performance.### Compliance and Certification:Conformance with BS EN ISO 15798:2013+A1:2017 is often a prerequisite for the marketing and sale of ophthalmic implants in many countries. Obtaining certification to this standard demonstrates your commitment to patient safety and quality, and can provide a competitive advantage in the global medical device market.To learn more about how BS EN ISO 15798:2013+A1:2017 can benefit your organization, please contact us today. Our team of experts is ready to assist you in navigating the requirements of this important standard and ensuring your ophthalmic implants meet the necessary compliance standards.