ISO 10993-12:2021 — Key Updates for Medical Device Testing
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
We all are aware that the 2021 version of the ISO 10993-12:2021 has been released and there is anxiety amongst the medical device professionals and manufacturers regarding the new additions in the amendment. Since this standard has repealed the 2012 version of ISO 10993-12, medical device manufacturers are keen to know if they are meeting the requirements set out in the amendment. However, we can say that the standard is only modified a little and this might give a sigh of relief to the readers. Let’s now move to the next section wherein we shall be discussing the changes made to the 2021 version of ISO 10993-12.
Elexes has supported 50+ biocompatibility test plans for medical device clients globally. As an RA/QA manager developing device biocompatibility data, this guide helps you navigate ISO 10993‑12 compliance.
What is new in the ISO 10993-12:2021?
A broad view of the definitions along with an extended focus on Biological Testing
The update to the ISO 10993-12 version focuses on clarification of the definitions along with a more detailed explanation of sample preparation recommendations for biological testing. The standard now clearly states that it mentions the requirements for preparing test samples per ISO 10993‑12:2021 for biological testing only as compared to the previous version that emphasized both biological testing and clinical testing.
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New Sample Preparation Requirements
Here are a few sample preparation requirements that are added in ISO 10993-12:2021:
- Extraction of limited contact Medical Devices for cytotoxicity can be conducted at 37 ± 1) °C for (24 ± 2) hours.
- The extraction period of prolonged/long-term devices extended from 24 hours to 72 hours since 24 hours is considered insufficient for an extract to provide the effect of chemicals released beyond 24 hours of use. However, if there is sufficient data available to prove that the chemical release beyond 2 hours is the same as that of below 24 hours, then 72 hours of extraction period is not required.
- Non-patient contacting portions of the medical device shall now be physically excluded from the extractions or the surface area of the non-patient contacting portions shall be excluded from extraction-ratio calculations.
Additional guidance on Absorbable materials
ISO 10993-12:2021 cross-refers to additional guidance (ISO/TS-37137-1) for extraction and handling of devices containing absorbable materials. The guidance document clearly states some additional requirements when testing these devices. For example, the temperature, pH value, and osmolarity during extractions, etc.
Updates on Reference Material (RM)
The new guideline updates options on the Reference material selection in ISO 10993‑12 (Positive and negative controls). Now, Laboratories can choose the RM based on their convenience and qualify the RM for biological purposes.
In summary, the changes to the new version are not exhaustive, however, a consultation with the regulatory body is always required prior to conducting the biological testing in order to ensure that the testings are acceptable by the regulatory body, as they will be the ones reviewing the test reports during the auditor during a regulatory submission review.
Concerned about where to begin?
Elexes team is here to help you. We have done a number of gap assessments between old and new versions of standards and advised companies on what action items must be taken to address the gaps and stay abreast with the latest applicable requirements. Feel free to contact us via email at jennifer@elexes.com or call +1 650-503-6615 for further details.
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FAQs
What is the scope of ISO 10993‑12:2021?
It defines how to select test samples, prepare them, pick reference materials, and prepare extracts for biological testing of medical devices.
How do you select the extraction solvent and conditions?
Extraction solvents and conditions shall be compatible with the device material and relevant to its intended clinical use – ensuring the solvent does not degrade, swell or generate particulates in the material.
What qualifies as a reference material under ISO 10993-12?
Reference material must be well-characterized, homogeneous and stable, with known property values (qualitative or quantitative) and traceability via a certificate.
How has ISO 10993-12 changed in the 2021 revision?
The 2021 edition refocuses the scope on biological evaluation only, harmonises definitions with ISO 10993‑18, and revises extraction conditions (e.g., extraction-condition table, exhaustive extraction rules), including updates for complex or absorbable materials.
When can you waive or reduce sample preparation per ISO 10993-12?
If scientific data shows that chemical release beyond an initial period remains the same, you may justify shorter extraction times (e.g., not extending to exhaustive extraction).
