ISO 10993-16:2017 Biological evaluation of medical devices —
Part 16: Toxicokinetic study design for degradation products and leachables
The toxicokinetic study design for degradation products and leachables is specified in ISO 10993-16:2017. This standard provides guidance on the selection of an appropriate study design to assess the potential toxicological risks posed by degradation products and leachables from medical devices.
What is ISO 10993-16:2017?
ISO 10993-16:2017 provides guidance on the design of toxicokinetic studies for degradation products and leachables from medical devices.
The standard is applicable to all types of medical devices, including those made from polymeric materials, metals, ceramics, and composite materials.
ISO 10993-16:2017 is intended to be used by analysts who are designing toxicokinetic studies for degradation products and leachables from medical devices.
The standard provides guidance on how to select the most appropriate study design based on the type of device and the degradation products or leachables of concern.
It also includes information on how to characterise the degradation products or leachables, and how to evaluate their toxicological risk.
What are the requirements of ISO 10993-16:2017?
The requirements of ISO 10993-16:2017 are as follows:
- The study design should be appropriate for the leachable being studied and the device under investigation.
- The study should be conducted using methods that are accepted by the scientific community.
- The study should be powered appropriately.
- The study design should allow for an assessment of potential local and systemic effects of the leachable.
- The study design should be able to identify any potential dose-response relationships.
- The study design should allow for an assessment of the variability in responses between individuals.
- The study design should be able to identify any potential time-related effects of the leachable.
What are the benefits of ISO 10993-16:2017?
The benefits of ISO 10993-16:2017 are many and varied. The standard provides guidance on the design of toxicokinetic studies, which are essential for the safety assessment of medical devices.
Toxicokinetic studies help to assess the potential risks of leachables and degradation products from medical devices. They can also provide valuable information on the absorption, distribution, metabolism and excretion of these substances.
ISO 10993-16:2017 can help to ensure that toxicokinetic studies are conducted correctly and produce reliable results. This, in turn, can help to protect patients and users of medical devices from potentially harmful substances.
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