BS EN ISO 21535:2024 Non-active Surgical Implants: Joint Replacement Implants

Specific Requirements for Hip-Joint Replacement Implants

Introducing the latest standard in the field of non-active surgical implants, the BS EN ISO 21535:2024. This comprehensive document sets forth the specific requirements for hip-joint replacement implants, ensuring the highest levels of safety, performance, and reliability. Released on July 24, 2024, this standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and application of hip-joint replacement implants.

Key Features and Benefits

• Standard Number: BS EN ISO 21535:2024
• Pages: 44
• Release Date: 2024-07-24
• ISBN: 978 0 539 03800 2
• Status: Standard

Comprehensive Coverage

This 44-page standard provides detailed guidelines and specifications that cover all aspects of hip-joint replacement implants. From material selection and design considerations to testing methods and performance criteria, the BS EN ISO 21535:2024 ensures that every aspect of the implant meets stringent quality and safety standards.

Ensuring Patient Safety and Implant Performance

Patient safety is paramount in the field of surgical implants. The BS EN ISO 21535:2024 standard outlines rigorous testing protocols and performance benchmarks that hip-joint replacement implants must meet. This ensures that the implants are not only safe for use but also deliver optimal performance over their intended lifespan.

Global Relevance and Compliance

As a globally recognized standard, the BS EN ISO 21535:2024 facilitates international trade and regulatory compliance. Manufacturers adhering to this standard can confidently market their products worldwide, knowing they meet the highest international benchmarks for quality and safety.

Who Should Use This Standard?

The BS EN ISO 21535:2024 is an invaluable resource for a wide range of stakeholders, including:

• Manufacturers: Ensuring that their hip-joint replacement implants meet the latest standards for safety and performance.
• Healthcare Professionals: Gaining a deeper understanding of the implants they use and recommend to patients.
• Regulatory Bodies: Establishing and enforcing compliance with international standards.
• Researchers and Academics: Accessing the latest guidelines and specifications for hip-joint replacement implants.

Why Choose BS EN ISO 21535:2024?

Choosing the BS EN ISO 21535:2024 standard means choosing a document that is:

• Up-to-Date: Reflecting the latest advancements and best practices in the field of hip-joint replacement implants.
• Comprehensive: Covering all critical aspects of implant design, testing, and performance.
• Globally Recognized: Facilitating international trade and regulatory compliance.
• Patient-Centric: Prioritizing patient safety and implant performance.

Conclusion

The BS EN ISO 21535:2024 standard is an essential tool for anyone involved in the field of hip-joint replacement implants. With its comprehensive guidelines and stringent requirements, it ensures that implants are safe, effective, and reliable. Stay ahead in the field of surgical implants by adhering to the latest standards and ensuring the highest levels of patient care and implant performance.

BS EN ISO 21535:2024

This standard BS EN ISO 21535:2024 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for hip-joint replacement implants. With regard to 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 hip joint replacement implants. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of hip replacement implants, but for some specific hip 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.