BS EN ISO 11979-2:2014

# BS EN ISO 11979-2:2014: Ophthalmic Implants - Intraocular Lenses## OverviewBS EN ISO 11979-2:2014 is the essential standard for intraocular lenses (IOLs), providing comprehensive requirements and test methods to ensure the safety, quality, and performance of these critical ophthalmic implants. Aligned with ISO 11979-2:2014, this British Standard is a crucial reference for manufacturers, healthcare providers, and regulatory bodies in the field of ophthalmology.## Scope and ApplicabilityThis standard specifies requirements for intraocular lenses, including:- General requirements for design, materials, and manufacturing- Specific requirements for different types of IOLs, such as monofocal, multifocal, and toric lenses- Test methods for evaluating optical, mechanical, and biological properties- Labeling and packaging requirements to ensure traceability and proper handlingThe standard applies to all IOLs intended for implantation in the human eye, whether for cataract surgery, refractive correction, or other ophthalmic procedures.## Key Benefits and Features- **Ensures Patient Safety**: Comprehensive requirements for biocompatibility, optical quality, and mechanical integrity help minimize the risk of complications and adverse events for patients.- **Supports Quality Manufacturing**: Detailed test methods and performance criteria guide manufacturers in designing and producing high-quality, reliable IOLs.- **Facilitates Regulatory Compliance**: Alignment with ISO 11979-2:2014 and other relevant standards simplifies the regulatory approval process for IOL products.- **Promotes Consistent Performance**: Standardized specifications and evaluation procedures enable healthcare providers to compare and select the most appropriate IOLs for their patients.- **Enhances Clinical Outcomes**: Improved safety, quality, and performance of IOLs can lead to better visual acuity, reduced complications, and increased patient satisfaction.## Technical SpecificationsBS EN ISO 11979-2:2014 covers a wide range of technical requirements and test methods for intraocular lenses, including:### Design and Materials- Optical design and power requirements- Lens diameter, thickness, and other dimensional specifications- Biocompatible materials and surface characteristics- Mechanical properties, such as flexibility and resistance to deformation### Optical Performance- Refractive power and dioptric power accuracy- Optical aberrations and image quality- Light transmittance and reflectance- Resistance to ultraviolet and blue light exposure### Mechanical Integrity- Resistance to impact, compression, and torsion- Durability and resistance to fatigue and wear- Stability of lens position and centration### Biological Safety- Cytotoxicity, sensitization, and irritation testing- Resistance to degradation and calcification- Sterilization and packaging requirements### Labeling and Packaging- Identification, traceability, and handling instructions- Shelf-life and storage conditions- Compatibility with surgical instruments and techniquesBy adhering to the comprehensive requirements outlined in BS EN ISO 11979-2:2014, manufacturers can develop safe, high-quality intraocular lenses that meet the evolving needs of ophthalmology patients and healthcare providers worldwide.