What ISO 10993-5 Cytotoxicity Testing Proves About a Device Material
A clinic picks gloves or a gown for how the material behaves against skin, fluids and repeated use, but the reason a product is allowed in patient contact at all is a set of laboratory tests most buyers never see. The ISO 10993 series is the framework behind those tests.
Understanding the two parts most often quoted on supplier websites makes vendor qualification far less mysterious.
What is the ISO 10993 series for?
ISO 10993 is the biological evaluation framework for medical devices. It starts with a risk-based question: what part of the body does the device contact, for how long, and what does it release under those conditions? Each part of the series then describes one type of testing.
What does ISO 10993-5 measure?
Part 5 covers in vitro cytotoxicity. A material sample is put in contact with living cells, and the laboratory assesses whether the material damages or kills them. It is an in vitro test, which means it runs in a laboratory dish rather than in an animal or a person.
Cytotoxicity is the front-line screen in a biological evaluation because a material that harms cells in the dish has no business going further. A clean cytotoxicity result is not proof a product is comfortable, only that it is not obviously toxic to cells.
Where do irritation and sensitisation sit?
| Test area | Standard part | What it asks |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Does the material harm cells in culture |
| Irritation | ISO 10993-23 in the current structure | Would contact with skin or mucosa produce a reaction |
| Sensitisation | ISO 10993-10 | Could repeated contact trigger an allergic response |
| Overall evaluation | ISO 10993-1 | Which of the above apply to this device at all |
The irritation and sensitisation work is what sits behind the difference between a glove that most staff wear without issue and one that produces complaints after a few shifts.
How does this reach a buying decision?
When staff report itching, redness or dryness, the first question is usually product chemistry rather than a missing test: residual accelerators, powder or a change in formulation. The second question is whether the batch in the storeroom matches the batch that was evaluated.
That is why traceability and an unchanged formulation matter more than a new logo on the carton.
Which products does this apply to?
Everyday items are where contact is longest. Nitrile examination gloves and fluid-resistant isolation gowns are worn for minutes to hours, and hypoallergenic paper tape stays on skin for days. For these products, a documented biological evaluation and a stable formulation are the parts a buyer can actually verify.
What should go in your vendor file?
Keep three things per product line. The contact category and duration, the tests the supplier states were performed with the standard parts named, and a lot number you can trace. If a supplier cannot say which part of ISO 10993 applies to the product, the answer is not a reason to walk away immediately, but it is a reason to ask again in writing.
Building a first order for a clinic or care home? The wholesale account is a low-commitment way to evaluate materials before a full switch, and wholesale pricing is available once you are ready to consolidate.
References
- ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (checked 19 September 2026)
- Public Health Ontario - infection prevention and control guidance for clinical settings (checked 19 September 2026)
- ASTM D6319 - Standard specification for nitrile examination gloves for medical application (checked 19 September 2026)
Related Reading
- Gloves for Canadian clinics and care homes
- Learning Hub - clinical and procurement guides
- Wholesale and multi-site ordering
- Glove contact dermatitis: Type I allergy vs Type IV irritation
- What does medical grade mean on supply labels?
- ISO 14971 risk files: what clinic buyers can ask suppliers for
Frequently Asked Questions
What is cytotoxicity testing in plain terms?
A sample of the device material is placed in contact with living cells in a laboratory. The laboratory then looks at whether the cells survive and behave normally. The result tells you whether anything in the material is toxic to cells, which is the first question in a biological evaluation.
Does ISO 10993-10 still cover irritation?
Part 10 has been reorganised. Irritation testing now has its own part, ISO 10993-23, while Part 10 covers skin sensitisation. Older test reports may still print 10993-10 for both, so read the test description rather than the number alone.
Does a glove need 10993 testing at all?
It depends on contact type and duration. A device in contact with intact skin is evaluated on a different scale from one that touches mucous membrane or blood. The evaluation starts with the framework in ISO 10993-1, which decides which tests apply in the first place.
Can I ask a supplier for the test reports?
Yes, and it is a reasonable request during vendor qualification. Ask for the biological evaluation summary, the test standards used and the laboratory that issued the report. A supplier who can produce that package is easier to keep in a quality file than one who answers with a marketing claim.
Last updated: September 2026. CliniEco Medical holds MDEL #35334 issued by Health Canada, and supplies clinics, long-term care homes and home-care programs across Canada.
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