ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2018 is the first part of an international standard that specifies the evaluation and testing procedures for medical devices that come into contact with the human body. This standard is important because it helps to ensure the safety of medical devices.
What is ISO 10993-1:2018
ISO 10993-1:2018 specifies the general framework for the biological evaluation of medical devices. It provides guidance on the selection of tests and evaluation procedures to determine the potential risks associated with a medical device and its constituents.
The standard also defines terms related to biological risks, and gives guidance on how to manage these risks throughout the product lifecycle.
The biological evaluation of medical devices is a key part of the overall risk management process for these products. By understanding the potential risks posed by a medical device, manufacturers can take steps to mitigate these risks and ensure that their products are safe for use.
What are the requirements of ISO 10993-1:2018 ?
The requirements of ISO 10993-1:2018 are as follows:
- The standard provides guidance on the selection of tests for evaluating the potential biological risks associated with medical devices.
- It does not provide specific test methods but rather general principles. That should be taken into account when choosing appropriate test methods.
- The standard applies to all medical devices, including in vitro diagnostic (IVD) medical devices. That come into contact with human tissue or body fluids.
- The standard is also applicable to those medical devices that are implanted into the human body or that are used to support or sustain life.
What are the benefits of ISO 10993-1:2018 ?
The benefits of ISO 10993-1:2018 include providing a framework for the biological evaluation of medical devices. This standard can help to ensure the safety of medical devices. By providing guidance on how to assess the risks associated with them.
ISO 10993-1:2018 can help manufacturers to design and produce safer medical devices. It can also help purchasers and regulators to make informed decisions about the safety of medical devices.
This standard is part of a series of standards on the biological evaluation of medical devices. Other standards in this series include ISO 10993-2:2018. Which provides guidance on determining the acceptability of medical devices using biological criteria. And ISO 10993-3:2018, which provides guidance on animal welfare issues related to the use of animals in the testing of medical devices.
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