New EN ISO 10993-1 has been published

Date: 3 May 2021

The new EN ISO 10991-1:2020 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) has recently been published in several European member states as national standard, based on the ISO 10993-1:2018.

According to the introduction of the new standard, “it is not intended that this document provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical device. … ISO 10993 series is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcome of the evaluation for each medical device, taking into consideration all the factors relevant to the medical device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.”

In line with Appendix B.2.2 (The biological evaluation plan) of ISO 10993-1:2018, risk management activities must be planned in advance. Since biocompatibility is a risk management activity, it requires  a biological evaluation plan drawn by qualified experts. It is emphasised that simply planning to conduct testing against all of the aspects of biocompatibility identified in Annex A does not meet the requirements.

If you need a help with preparing expert biological evaluation plans and reports, please do not hesitate to contact This email address is being protected from spambots. You need JavaScript enabled to view it., Senior Manager Regulatory Affairs – Medical Devices.