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What is EN ISO 10993-13:2021?


EN ISO 10993-13:2021 is a standard that provides guidance on the evaluation of medical devices with regard to their potential for local effects after implantation or other types of contact with the human body. This international standard was developed by the International Organization for Standardization (ISO) and is applicable to all types of medical devices, including implants, surgical instruments, and diagnostic devices.

Scope and Purpose

The scope of EN ISO 10993-13:2021 is to establish a systematic evaluation process for assessing the local effects of medical devices. The purpose of this standard is to ensure the safety and effectiveness of medical devices in terms of their biological compatibility with the human body. It establishes principles, requirements, and guidelines for conducting biocompatibility testing of medical devices, specifically focusing on the evaluation of the local effects.

Key Requirements

The key requirements outlined in EN ISO 10993-13:2021 include the selection of appropriate test methods, the evaluation of device extracts, and the assessment of tissue reactions. Test methods should be chosen based on the intended use and duration of contact between the device and the human body. Device extracts are assessed to determine if they cause any adverse biological responses. Additionally, tissue reactions are evaluated after implantation or contact with the device to assess any potential local effects.


EN ISO 10993-13:2021 plays a crucial role in ensuring the safety and effectiveness of medical devices by providing guidelines for evaluating their local effects on the human body. Through this standard, manufacturers can conduct comprehensive biocompatibility testing to assess the potential risks associated with their products. Compliance with this standard helps to minimize the likelihood of adverse reactions or complications that may arise from the use of medical devices.

Overall, EN ISO 10993-13:2021 is an essential tool for the medical device industry, enabling manufacturers to develop safe and biocompatible products. By adhering to the principles outlined in this standard, medical device companies can prioritize patient safety and achieve regulatory compliance.



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