Biological evaluation of MDs - Standard 10993-7

Medical devices must follow a very specific biological evaluation procedure described in the ISO 10993 standard called “ Biological evaluation of medical devices ”.
Being often in direct contact with the human body, it is essential to assess the possible interactions and the potential side effects they can cause.
This standard therefore governs the analyzes of the risks associated with these medical devices.
The POLYMEX laboratory is able to carry out some of the many analyzes of this standard, in particular those relating to the chemical characterization of materials used in medical devices and the study of extractables:
- Biological evaluation of medical devices: Ethylene oxide sterilization residues according to standard 10 993-7
- Biological evaluation of medical devices : Preparation of samples and reference materials according to standard 10 993-12
- Biological evaluation of medical devices: Chemical characterization of medical device materials according to standard 10 993-18

What is behind the 10993-7 standard?

This standard specifies the allowable limits for residues of ethylene oxide and ethylene hydrochloride for individual medical devices sterilized with ethylene oxide.
Remember that ethylene oxide is a flammable gas, irritating to body surfaces and very explosive. It has many biological effects such as irritation, organ damage, mutagenicity or even carcinogenicity.
The same is true for ethylene hydrochloride, a flammable liquid, irritant to body surfaces, mutagenic, foetotoxic and teratogenic, but it is also acutely toxic because it is rapidly absorbed through the skin.

What is behind the 10993-7 standard?

The standard is therefore based on the maximum daily doses of ethylene oxide and ethylene hydrochloride.
But there are 3 categories of exposure:
- limited exposure (A): medical devices for which the cumulative sum of single, multiple or repeated contact time is less than or equal to 24 hours;
- prolonged exposure (B): medical devices for which the cumulative sum of duration of single, multiple or repeated contact is likely to exceed 24 hours, while remaining less than or equal to 30 days;
- permanent exposure (C): medical devices for which the cumulative sum of duration of single, multiple or repeated contact exceeds 30 days.

Each type of exposure corresponds to a different maximum acceptable daily dose of EO and HSE, also taking into account the exceptions according to the type of population such as for example for newborns where the rate must be much lower than that acceptable for an adult .
To determine whether the device complies with the standard, extractions must be carried out according to methods validated and approved by the standards committee.

In fact, the samples intended for analysis must be selected to be truly representative of the product and particular attention must be paid to factors that may influence the level of residues or the rate of dissipation of the residue, such as aeration, the composition of the product. 'packaging,…)

To proceed with the extractions there are two methods:
1 / Extraction with simulation of use : more trying conditions compared to the intended use.
2 / Exhaustive extraction : conditions intended to recover all of the residues present in a medical device.

With its experience, our laboratory is able to perform these tests according to standard 10 993 while respecting the correct deadlines ( 4 weeks ).

Other examples from industry

determination of residual hct/toc in medical devices

Determination of residual HCT/TOC in medical devices

task analyzes on orthopedic prostheses

Task analyzes on orthopedic prostheses

biological evaluation of medical devices - standard 10993-7

Biological evaluation of medical devices - Standard 10993-7

10993 -12 & 18