ISO 10993-13:2010 Biological evaluation of medical devices —
Part 13: Identification and quantification of degradation products from polymeric medical devices
Polymeric medical devices are widely used in a variety of applications, from blood vessels and catheters to pacemakers and artificial joints. While these devices are generally safe and effective, it is important to be aware of the potential for degradation products to be released from the device over time.
The purpose of ISO 10993-13:2010 is to provide guidance on the identification and quantification of such degradation products. This article provides an overview of the standard and its requirements.
What is ISO 10993-13:2010?
ISO 10993-13:2010 provides guidance on the identification and quantification of degradation products from polymeric medical devices. This standard is applicable to all types of polymeric medical devices, including those made from natural and synthetic polymers.
The standard includes four methods for the identification and quantification of degradation products:
- High performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Mass spectrometry (MS)
- Fourier transform infrared spectroscopy (FTIR)
What are the requirements of ISO 10993-13:2010
The requirements of ISO 10993-13:2010 are as follows:
- The degradation products from the device shall not be toxic to human cells or tissues.
- The identity and quantity of degradation products shall be determined.
- The potential for release of degradation products from the device shall be assessed.
- The effects of the degradation products on the safety and performance of the device shall be evaluated.
What are the benefits of ISO 10993-13:2010?
There are many benefits to adhering to the requirements of ISO 10993-13:2010. This standard provides guidance on how to identify and quantify degradation products from polymeric medical devices.
The benefits of following this standard include:
- Improved patient safety – By identifying and quantifying degradation products, manufacturers can ensure that their devices are safe for patients.
- Enhanced product quality – Adhering to the requirements of this standard can help to improve the overall quality of medical devices.
- Cost savings – Following the guidance in this standard can help manufacturers save money by avoiding costly recalls or other problems associated with non-compliant devices.
- Improved marketability – Devices that meet the requirements of ISO 10993-13:2010 are more likely to be accepted by regulatory authorities and healthcare professionals.
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