BS EN ISO 21536:2024 Non-active Surgical Implants

Joint Replacement Implants: Specific Requirements for Knee-Joint Replacement Implants

Introducing the BS EN ISO 21536:2024, the definitive standard for non-active surgical implants, specifically focusing on joint replacement implants with a particular emphasis on knee-joint replacement implants. This comprehensive document is an essential resource for professionals in the medical and surgical fields, providing detailed guidelines and requirements to ensure the highest quality and safety in knee-joint replacement procedures.

Key Features and Benefits

• Standard Number: BS EN ISO 21536:2024
• Pages: 38
• Released: 2024-07-24
• ISBN: 978 0 539 03801 9
• Status: Standard

This standard is meticulously crafted to address the specific requirements for knee-joint replacement implants, ensuring that all aspects of design, materials, testing, and performance are covered. With 38 pages of in-depth information, it serves as a comprehensive guide for manufacturers, healthcare providers, and regulatory bodies.

Comprehensive Coverage

The BS EN ISO 21536:2024 standard provides extensive coverage on various critical aspects, including:

• Design Specifications: Detailed guidelines on the design and construction of knee-joint replacement implants to ensure optimal functionality and patient safety.
• Material Requirements: Specifications for the materials used in the manufacturing of knee-joint implants, focusing on biocompatibility, durability, and performance.
• Testing Protocols: Rigorous testing procedures to validate the performance and safety of knee-joint replacement implants under various conditions.
• Performance Criteria: Benchmarks and standards for the performance of knee-joint implants, ensuring they meet the highest levels of efficacy and reliability.

Why Choose BS EN ISO 21536:2024?

Adopting the BS EN ISO 21536:2024 standard offers numerous advantages:

• Enhanced Patient Safety: By adhering to the stringent requirements outlined in this standard, healthcare providers can significantly reduce the risk of complications and improve patient outcomes.
• Regulatory Compliance: This standard helps manufacturers and healthcare facilities comply with national and international regulations, ensuring that knee-joint replacement implants meet the necessary legal and safety requirements.
• Quality Assurance: The detailed guidelines and testing protocols provided in this standard ensure that knee-joint replacement implants are of the highest quality, offering long-term reliability and performance.
• Industry Best Practices: Stay ahead of the curve by implementing the latest industry best practices and innovations in knee-joint replacement technology.

Who Should Use This Standard?

The BS EN ISO 21536:2024 standard is an invaluable resource for a wide range of professionals, including:

• Medical Device Manufacturers: Ensure your knee-joint replacement implants meet the highest standards of quality and safety.
• Healthcare Providers: Implement best practices in knee-joint replacement procedures to enhance patient care and outcomes.
• Regulatory Bodies: Utilize this standard to assess and approve knee-joint replacement implants, ensuring they comply with all necessary regulations.
• Researchers and Academics: Gain insights into the latest advancements and requirements in knee-joint replacement technology.

Conclusion

The BS EN ISO 21536:2024 standard is a critical tool for anyone involved in the design, manufacture, regulation, or implementation of knee-joint replacement implants. With its comprehensive guidelines and rigorous requirements, it ensures that knee-joint replacement procedures are performed with the highest levels of safety, quality, and efficacy. Stay at the forefront of medical innovation and patient care by adopting this essential standard.

BS EN ISO 21536:2024

This standard BS EN ISO 21536:2024 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.