The latest version of a key horizontal Standard used for the biological evaluation of medical devices has been published by NSAI.
I.S. EN ISO 1993-1:2020 - "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is a fundamental Standard in evaluating the biological testing of medical devices. The horizontal Standard specifies principles governing the biological evaluation of medical devices and categorization of medical devices based on the nature and duration of their contact with the body. The Standard applies to the evaluation of both materials and devices that come into contact with the body during the specified intended use. It provides guidelines for the assessment of biological hazard risks, such as breakage of the medical device and the introduction of changes to medical device design, composition or manufacturing processes. The main changes in the edition include:
- Revised Annex A, "Endpoints to be addressed in a biological risk assessment"
- New Annex B, "Guidance on the conduct of biological evaluation within a risk management process"
- Additional information on the evaluation of "non-contacting medical devices" and new information on the evaluation of "transitory-contacting medical devices"
- Additional information on the evaluation of nanomaterials and absorbable materials
Subsequent parts of this Standard (Parts 2-23) cover specific aspects of biological assessments and test methods.
It should be noted that the new edition of the Standard has been delinked from the European Harmonization process and does not contain Annex Z, demonstrating relationships with relevant European Directives and/or Regulations.
Users of the preceding Standard should assess biological testing data of existing products against this new Standard, identifying any gaps and plan compliance with the new edition. It is advisable that users consult with their Notified Body(s) when planning upgrades to new versions of Standards.