ISO 10993: Ensuring biological safety of medical devices in the context of the histopathological tissue evaluation.
Patho-Logica is committed to the ISO 10993-6 being a global center for histopathology for invasive medical device in pre-clinical trials. We have a vast experience in the evaluation of the medical device safety within the tissue using a novel laser dissection technique of the plastic embedded tissues in early stages of the non-clinical studies.
What is ISO 10993?
ISO 10993 is an international standard that defines requirements for the evaluation of the biological safety of medical devices. The purpose of the standard is to protect patients from potential risks that may be caused by contact with materials used in the production of the devices. An important part of the ISO refers to the histopathological evaluation of the tissue around the implanted device (ISO10993-6).
Scope of Application:
The standard applies to all types of medical devices, including:
- Implanted devices and implants, such as surgical implants and artificial joints, these are evaluated in an animal study for the safety. This is where Patho-Logica expertise is expressed, performing histopathological evaluation of the tissue using advanced techniques.
- Non-implanted devices, such as hearing aids and pacemakers
- Diagnostic devices, such as MRI and CT machines
- Medical consumables, such as bandages and hygiene products
The Evaluation Process:
The biosafety assessment of a medical device according to ISO 10993 is a multi-step process that includes:
- Identification of the materials used in the manufacture of the device
- Assess the risk potential of each substance
- Performing laboratory tests to evaluate the biological effects of the materials
- Analyzing the results of the tests and assessing the overall risk of the device
- Preparation of an evaluation report documenting the entire process
In conclusion
ISO 10993 is an essential tool for ensuring the safety of medical devices. By using this standard, manufacturers can protect patients, improve consumer confidence, and make it easier to develop and market their products around the world. Patho-Logica is involved in the evaluation of the tissue and is following completely the ISO 10993-6 SOP.
