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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>BS EN ISO 12417-1:2024 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
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immediate downloadReleased: 2024-02-28
BS EN ISO 12417-1:2024 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements

BS EN ISO 12417-1:2024

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements

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Standard number:BS EN ISO 12417-1:2024
Pages:58
Released:2024-02-28
ISBN:978 0 539 16021 5
Status:Standard

BS EN ISO 12417-1:2024 - Cardiovascular Implants and Extracorporeal Systems: Vascular Device-Drug Combination Products General Requirements

Introducing the latest standard in cardiovascular healthcare, the BS EN ISO 12417-1:2024. This comprehensive document sets the benchmark for vascular device-drug combination products, ensuring the highest level of safety, efficacy, and quality in cardiovascular implants and extracorporeal systems. Released on February 28, 2024, this standard is an essential resource for professionals in the medical device industry, healthcare providers, and regulatory bodies.

Key Features and Benefits

  • Standard Number: BS EN ISO 12417-1:2024
  • Pages: 58
  • Release Date: 2024-02-28
  • ISBN: 978 0 539 16021 5
  • Status: Standard

Comprehensive Coverage

This 58-page document provides detailed guidelines and requirements for the development, testing, and implementation of vascular device-drug combination products. It covers a wide range of topics, including:

  • Design and manufacturing requirements
  • Biocompatibility and material selection
  • Performance testing and validation
  • Clinical evaluation and risk management
  • Regulatory compliance and documentation

Ensuring Safety and Efficacy

The BS EN ISO 12417-1:2024 standard is designed to ensure that vascular device-drug combination products meet the highest standards of safety and efficacy. By adhering to these guidelines, manufacturers can minimize risks and enhance the performance of their products, ultimately improving patient outcomes.

Global Relevance

As an internationally recognized standard, BS EN ISO 12417-1:2024 aligns with global regulatory requirements, making it easier for manufacturers to achieve compliance in multiple markets. This standard is a valuable tool for navigating the complex landscape of medical device regulations and ensuring that products meet the stringent requirements of regulatory bodies worldwide.

Why Choose BS EN ISO 12417-1:2024?

Expertly Crafted

Developed by leading experts in the field, this standard reflects the latest advancements in cardiovascular technology and best practices. It is a result of extensive research, collaboration, and consultation with industry stakeholders, ensuring that it addresses the most critical aspects of vascular device-drug combination products.

Enhanced Patient Care

By following the guidelines set forth in BS EN ISO 12417-1:2024, healthcare providers can offer patients the most advanced and reliable cardiovascular treatments available. This standard supports the development of innovative products that can significantly improve patient care and outcomes.

Streamlined Compliance

Compliance with BS EN ISO 12417-1:2024 simplifies the regulatory approval process, reducing time-to-market for new products. Manufacturers can confidently navigate the regulatory landscape, knowing that their products meet the highest standards of quality and safety.

Who Should Use This Standard?

BS EN ISO 12417-1:2024 is an indispensable resource for a wide range of professionals, including:

  • Medical device manufacturers
  • Regulatory affairs specialists
  • Quality assurance professionals
  • Clinical researchers
  • Healthcare providers
  • Regulatory bodies

Invest in Quality and Innovation

Stay ahead of the curve with BS EN ISO 12417-1:2024. This standard is not just a document; it is a commitment to quality, safety, and innovation in cardiovascular healthcare. By integrating these guidelines into your processes, you can ensure that your products are at the forefront of medical technology, providing the best possible care for patients worldwide.

Order Your Copy Today

Don't miss out on this essential resource. Ensure that your organization is equipped with the latest standards and guidelines to excel in the competitive field of cardiovascular implants and extracorporeal systems. Order your copy of BS EN ISO 12417-1:2024 today and take the first step towards excellence in medical device manufacturing and patient care.

ISBN: 978 0 539 16021 5

Release Date: 2024-02-28

Pages: 58

Invest in the future of cardiovascular healthcare with BS EN ISO 12417-1:2024. Your commitment to quality and innovation starts here.

DESCRIPTION

BS EN ISO 12417-1:2024


This standard BS EN ISO 12417-1:2024 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products is classified in these ICS categories:
  • 11.040.40 Implants for surgery, prosthetics and orthotics
This document specifies requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not permanent implants. NOTE 1        Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary. This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires). This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device. This document does not provide a comprehensive pharmacological evaluation of VDDCPs. NOTE 2        Some information about the requirements of certain national and regional authorities is given in Annex B. The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings. NOTE 3        For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13. This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins. This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).
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