The international safety standard on the biological evaluation of medical devices within a risk management process has undergone a lengthy and comprehensive revision. This blog post discusses the results.
It goes without saying that people need to be protected from the potential biological risks that could arise from the use of medical devices, yet the range of biological hazards is wide and complex.
With that in mind, and drawing on numerous international and national standards and guidelines, ISO produces a series of standards on how best to conduct the biological evaluation of medical devices. The series currently runs to 18 standards covering specific aspects of biological assessments and related tests. All are subject to regular review.
As part of that process, Part 1 – which was last published in 2009 – has undergone a full revision. The resulting standard has now been published as: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
What’s covered in this standard?
covers the biological evaluation of medical devices within a risk management process as part of the overall evaluation and development of each medical device.
It applies to the evaluation of materials and devices that are expected to have direct or indirect contact with a patient’s body during intended use. However note that it also applies to medical devices in direct or indirect contact with a device user’s body, if the device is intended to protect the user: e.g. surgical gloves and masks.
The standard covers all types of medical devices including active, non-active, implantable and non-implantable ones. It also gives guidelines on assessing biological hazards arising from risks such as that the device changes over time; or the risk that the device or a component breaks and in doing so exposes body tissue to new or novel materials.
The standard combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests. This enables a full evaluation to be made of the biological responses of each medical device, relevant to its safety in use.
The standard also excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy agents and other pathogens. So what’s now new?
Changes to the 2020 version
has been revised to reflect the fact that as our understanding of the basic mechanisms of host responses advances, we can minimize the number and exposure of test animals. To that end the revised standard gives preference to chemical, physical, morphological and topographical characterization testing and in vitro models wherever these methods produce equally relevant information to that obtained from live animal testing.
The specific changes to the standard therefore include a significantly revised Annex A that has been changed to include physical and/or chemical information as part of the endpoints to be addressed in a biological risk assessment. This information has now become a prerequisite for any risk assessment. As well, Annex B on guidance on the risk management process has been replaced with “Guidance on the conduct of biological evaluation within a risk management process”.
We’ve also introduced additional definitions for terms used throughout the BS EN ISO 10993 series; additional information on the evaluation of “Non-contacting medical devices”; new information on the evaluation of “Transitory-contacting medical devices; and additional information on the evaluation of nanomaterials and absorbable materials. We’ve also made significant editorial changes throughout the document to make it clearer and easier to use.
It’s not the intention of this document to provide a rigid set of pass/fail test methods that could either constrain the development of new devices or gives a false sense of security with others. The series is for use by qualified and experienced professionals who are able to interpret its requirements, taking all relevant factors into account.
In that way the standard and the series as a whole can provide the best approach to protecting people in contact with medical devices from biological risks.
