ISO 10993-14:2001 Biological evaluation of medical devices —
Part 14: Identification and quantification of degradation products from ceramics
In order to ensure the safety of medical devices made from ceramic materials, it is important to be able to identify and quantify any degradation products that may be produced during use. ISO 10993-14:2001 provides guidance on how to carry out this evaluation.
What is ISO 10993-14:2001?
ISO 10993-14:2001 is an international standard that provides guidance on the identification and quantification of degradation products from ceramics.
The standard covers the following topics:
- Identification of degradation products
- Quantification of degradation products
- Assessment of the potential risks associated with degradation products
The standard is applicable to all types of ceramics, including but not limited to:
- Refractory ceramics
What are the requirements of ISO 10993-14:2001?
- The standard requires the identification and quantification of degradation products from ceramics used in medical devices.
- Degradation products must be identified in order to assess their potential toxicity.
- The amount of degradation products produced must be quantified in order to determine whether they pose a risk to patients.
- ISO 10993-14:2001 also provides guidance on how to perform biological evaluations of medical devices containing ceramics.
What are the benefits of ISO 10993-14:2001?
There are many benefits to using ISO 10993-14:2001 when conducting a biological evaluation of medical devices. This standard provides guidance on how to identify and quantify degradation products from ceramics.
This standard can help to ensure that the degradation products from ceramics are not harmful to patients or users of medical devices. Additionally, this standard can help to ensure that the degradation products do not adversely affect the performance of the medical device.
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