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## EN ISO 16672:2018 - Healthcare Technology Standard### OverviewThe EN ISO 16672:2018 standard, titled 'Ophthalmic implants - Posterior chamber intraocular lenses', is a critical healthcare technology standard that provides essential guidelines and requirements for the design, manufacture, and performance of posterior chamber intraocular lenses (IOLs). As a key component of modern cataract surgery, these implantable lenses play a vital role in restoring vision and improving the quality of life for millions of patients worldwide.### Scope and ApplicabilityThis international standard applies to all posterior chamber IOLs, including monofocal, multifocal, and accommodating lenses. It covers a wide range of technical specifications and testing procedures to ensure the safety, efficacy, and long-term reliability of these medical devices. Key areas addressed include:- Materials and biocompatibility- Optical and mechanical design- Sterilization and packaging- Labeling and instructions for use- Clinical evaluation and post-market surveillance### Benefits of ComplianceAdhering to the EN ISO 16672:2018 standard offers numerous benefits for healthcare providers, medical device manufacturers, and, most importantly, patients:#### Improved Patient SafetyThe standard's rigorous requirements for materials, design, and testing help to minimize the risk of adverse events, such as lens dislocation, opacification, or inflammation, ensuring the highest levels of patient safety and visual outcomes.#### Regulatory ComplianceCompliance with EN ISO 16672:2018 is often a prerequisite for obtaining regulatory approvals and market access for posterior chamber IOLs, both within the European Union and globally.#### Quality AssuranceThe standard provides a comprehensive framework for quality management, from product development to post-market surveillance, helping manufacturers to consistently deliver high-quality, reliable medical devices.#### Harmonized RequirementsAs an identical adoption of the ISO 16672 international standard, EN ISO 16672:2018 aligns with global best practices, facilitating international trade and reducing the burden of compliance for manufacturers.### Technical SpecificationsThe EN ISO 16672:2018 standard covers a wide range of technical requirements and test methods for posterior chamber IOLs, including:- **Materials and Biocompatibility** - Optical and non-optical materials - Cytotoxicity, sensitization, and irritation testing - Accelerated aging and durability- **Optical and Mechanical Design** - Refractive power, aberrations, and light transmission - Mechanical stability, haptic design, and diopter range- **Sterilization and Packaging** - Sterilization methods and validation - Packaging integrity and shelf-life- **Labeling and Instructions for Use** - Detailed product information and warnings - Surgical techniques and implantation guidelines- **Clinical Evaluation and Post-Market Surveillance** - Pre-clinical and clinical studies - Post-market clinical follow-up and adverse event reportingBy adhering to the comprehensive requirements outlined in EN ISO 16672:2018, medical device manufacturers can ensure the safety, quality, and performance of their posterior chamber IOLs, ultimately contributing to improved patient outcomes and satisfaction.