Health Care Technology Official British Standard

BS EN ISO 14607:2018

Comprehensive healthcare technology standard BS EN ISO 14607:2018. Ensure compliance and best practices for non-active surgical implants. Detailed technical specifications and benefits.

## BS EN ISO 14607:2018 - Non-active Surgical ImplantsThis British Standard, BS EN ISO 14607:2018, specifies requirements for non-active surgical implants. It covers a wide range of healthcare technologies, including:- Orthopaedic implants- Dental implants- Cardiovascular implants- Ophthalmic and ENT implants### Detailed Technical SpecificationsBS EN ISO 14607:2018 provides comprehensive technical requirements for the design, manufacture, and testing of non-active surgical implants, including:- Materials and biocompatibility- Mechanical properties and strength- Dimensional tolerances and surface characteristics- Sterilization and packaging- Labelling and information to be supplied by the manufacturerThe standard ensures that non-active surgical implants meet the highest standards of quality, safety, and performance, protecting both patients and healthcare providers.### Ensuring Compliance and Best PracticesCompliance with BS EN ISO 14607:2018 is essential for any manufacturer or supplier of non-active surgical implants. By adhering to this standard, you can:- Demonstrate your commitment to patient safety and quality- Streamline regulatory approval processes- Differentiate your products in a competitive market- Reduce the risk of product failures or recallsThe standard also promotes best practices in the design, production, and use of non-active surgical implants, helping to improve patient outcomes and reduce healthcare costs.### Benefits of Implementing BS EN ISO 14607:2018Adopting BS EN ISO 14607:2018 can provide a range of benefits for healthcare organizations and medical device manufacturers, including:- Improved patient safety and reduced risk of complications- Enhanced product quality and reliability- Streamlined regulatory compliance and market access- Increased customer confidence and brand reputation- Reduced liability and legal risks- Alignment with international best practices and standardsBy implementing this comprehensive healthcare technology standard, you can ensure that your non-active surgical implants meet the highest standards of quality, safety, and performance, ultimately contributing to better patient outcomes and a more sustainable healthcare system.

Technical Information

Health Care Technology
BSI Group
978 0 539 02286 5
Specification Details
  • Non-active surgical implants
  • Mammary implants
  • Particular requirements
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