BS EN ISO 10993-15:2023
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
| Standard number: | BS EN ISO 10993-15:2023 |
| Pages: | 30 |
| Released: | 2023-05-24 |
| ISBN: | 978 0 580 97108 2 |
| Status: | Standard |
BS EN ISO 10993-15:2023 Biological Evaluation of Medical Devices - Identification and Quantification of Degradation Products from Metals and Alloys
Introducing the BS EN ISO 10993-15:2023, a comprehensive standard that provides a detailed guide for the biological evaluation of medical devices, specifically focusing on the identification and quantification of degradation products from metals and alloys. This standard is an essential tool for manufacturers, researchers, and regulatory bodies involved in the development, testing, and approval of medical devices.
Released on 24th May 2023, this standard is the latest in the series, reflecting the most recent advancements and understanding in the field. With a total of 30 pages, it provides a thorough and in-depth analysis of the subject matter, ensuring that you have all the information you need at your fingertips.
Key Features
The BS EN ISO 10993-15:2023 standard is packed with valuable features that make it a must-have for anyone involved in the medical devices industry. Here are some of the key features:
- Comprehensive Coverage: The standard covers all aspects of the identification and quantification of degradation products from metals and alloys in medical devices. This includes detailed guidelines on testing methods, data interpretation, and reporting requirements.
- Up-to-Date Information: As a 2023 release, this standard includes the most recent research and developments in the field. This ensures that you are working with the most current and accurate information available.
- Internationally Recognized: The BS EN ISO 10993-15:2023 is recognized and accepted worldwide. This means that compliance with this standard will be recognized by regulatory bodies around the globe, facilitating international trade and cooperation.
Why Choose BS EN ISO 10993-15:2023?
Choosing the BS EN ISO 10993-15:2023 standard means choosing a tool that is trusted and used by professionals worldwide. It is a testament to your commitment to quality, safety, and regulatory compliance. The standard's ISBN is 978 0 580 97108 2, making it easy to reference and locate in any library or database.
Whether you are a manufacturer looking to ensure the safety and effectiveness of your medical devices, a researcher seeking to stay abreast of the latest developments in the field, or a regulatory body tasked with ensuring the safety and efficacy of medical devices, the BS EN ISO 10993-15:2023 standard is an invaluable resource.
Invest in the BS EN ISO 10993-15:2023 standard today and take a step towards excellence in the field of medical devices. Remember, quality and safety are not just goals, they are standards.
Order Now
Don't miss out on this opportunity to stay ahead in the medical devices industry. Order your copy of the BS EN ISO 10993-15:2023 standard today and ensure that you are equipped with the knowledge and tools necessary to excel in this rapidly evolving field.
BS EN ISO 10993-15:2023
This standard BS EN ISO 10993-15:2023 Biological evaluation of medical devices is classified in these ICS categories:
- 11.100.20 Biological evaluation of medical devices
This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available.
Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993 .
Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (<10–6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable clauses of ISO 10993-1 and ISO 10993-17).