PD ISO/TS 17137:2021 Cardiovascular Implants and Extracorporeal Systems. Cardiovascular Absorbable Implants

Standard Number: PD ISO/TS 17137:2021

Pages: 46

Released: 2021-09-17

ISBN: 978 0 539 15967 7

Name: Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants

Status: Standard

Overview

Introducing the PD ISO/TS 17137:2021, a comprehensive standard that sets the benchmark for cardiovascular implants and extracorporeal systems, specifically focusing on cardiovascular absorbable implants. This standard is an essential resource for professionals in the medical device industry, healthcare providers, and researchers dedicated to advancing cardiovascular health.

Key Features

• Comprehensive Coverage: Spanning 46 pages, this standard provides in-depth guidelines and specifications for the development, testing, and application of cardiovascular absorbable implants.
• Up-to-Date Information: Released on 2021-09-17, the PD ISO/TS 17137:2021 reflects the latest advancements and best practices in the field of cardiovascular implants.
• Global Recognition: As an ISO/TS standard, it is recognized and respected worldwide, ensuring that your products meet international quality and safety standards.
• ISBN: 978 0 539 15967 7, making it easy to reference and locate in libraries and databases.

Why Choose PD ISO/TS 17137:2021?

The PD ISO/TS 17137:2021 standard is designed to support the development of innovative and safe cardiovascular absorbable implants. By adhering to this standard, manufacturers can ensure that their products are reliable, effective, and compliant with international regulations. This not only enhances patient safety but also boosts the credibility and marketability of the products.

Benefits for Manufacturers

• Quality Assurance: Adopting this standard helps manufacturers maintain high-quality production processes, reducing the risk of defects and recalls.
• Regulatory Compliance: Ensures that products meet the stringent requirements of regulatory bodies, facilitating smoother approval processes.
• Market Access: Products that comply with international standards are more likely to be accepted in global markets, expanding business opportunities.

Benefits for Healthcare Providers

• Enhanced Patient Safety: Using implants that meet the PD ISO/TS 17137:2021 standard ensures that patients receive high-quality, safe, and effective treatments.
• Improved Outcomes: Reliable and well-tested implants contribute to better patient outcomes and reduced complications.
• Trust and Confidence: Healthcare providers can trust that the products they use are backed by rigorous standards and thorough testing.

Benefits for Researchers

• Guidance and Framework: Provides a solid framework for conducting research and development in the field of cardiovascular absorbable implants.
• Benchmarking: Offers a benchmark for evaluating new materials and technologies, ensuring they meet established standards.
• Collaboration: Facilitates collaboration with other researchers and institutions by providing a common set of guidelines and terminology.

Content Highlights

The PD ISO/TS 17137:2021 standard covers a wide range of topics essential for the development and application of cardiovascular absorbable implants. Some of the key areas include:

• Material Specifications: Detailed requirements for the materials used in absorbable implants, ensuring biocompatibility and safety.
• Design and Manufacturing: Guidelines for the design and manufacturing processes to ensure consistency and quality.
• Testing and Validation: Comprehensive testing protocols to validate the performance and safety of the implants.
• Clinical Considerations: Recommendations for clinical use, including patient selection, implantation procedures, and post-operative care.
• Regulatory Compliance: Information on meeting regulatory requirements and obtaining necessary approvals.

Conclusion

The PD ISO/TS 17137:2021 standard is an invaluable resource for anyone involved in the development, production, and application of cardiovascular absorbable implants. By adhering to this standard, you can ensure that your products are of the highest quality, meet international regulations, and ultimately contribute to better patient outcomes. Invest in the PD ISO/TS 17137:2021 standard today and take a significant step towards excellence in cardiovascular healthcare.

PD ISO/TS 17137:2021

This standard PD ISO/TS 17137:2021 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.

This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of this document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant can incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant.