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Check the European amendment
Genorma lists EN ISO 10993-5:2009 as published and sells EN ISO 10993-5:2009/A11:2025 separately. The EVS catalogue confirms the consolidated European reference including A11:2025. The older base year should not lead a buyer to overlook the published European amendment.
The public scope concerns methods for assessing cell responses in vitro to devices or their extracts. This guide does not reproduce the method, select experimental conditions or interpret results. Those decisions need the licensed document and a competent biological-evaluation and laboratory team.
Choose the task before choosing the service
| Task | Role of Part 5 | Question for the provider |
|---|---|---|
| Plan the overall biological evaluation | A possible test-method input. | Who justifies the evaluation strategy for the actual device? |
| Commission cytotoxicity work | Addresses this specific in vitro subject. | What identified sample and justified approach will the work cover? |
| Review a changed material or process | Existing test evidence may be relevant. | Does it still represent the changed finished device? |
| Reach a biological-safety conclusion | Provides one defined source of evidence. | How will the responsible evaluator interpret it with the wider evidence? |
Ask for an evaluation brief before ordering a test package. Describe the device, intended contact and relevant materials and processing information for the qualified evaluator. The evaluator can explain the purpose of the proposed work and how its result will be used. Purchasing an assortment of familiar test names without that rationale can produce reports that do not answer the device's actual evaluation question.
Make sample identity explicit. A material supplier's report, a prototype sample and a finished processed device are different evidence subjects. Ask the provider to state what the sample represents and what limits follow from that choice. Retain model, batch and processing identifiers so the final report can be related to the product under review. These are commissioning questions, not instructions for preparing laboratory specimens.
Write a deliverable that can be reviewed
The quotation should explain the selected reference and amended set, the scope of the work, responsibilities for sample information and the final deliverables. Ask how deviations, excluded products and any limitations will be described. A short certificate with a product name may leave less usable information than the review team needs; agree the reporting scope before commissioning.
Keep responsibility for interpretation identifiable. Laboratory observations and a biological-evaluation conclusion are connected but distinct deliverables. Ask whether the quotation includes only laboratory work or also the evaluation service, and who has the competence and product information needed for each. This avoids assuming that a test provider has accepted responsibility for the entire device assessment.
For a changed device, organise the differences before requesting reuse of evidence. A new supplier, revised formulation, processing change or altered product construction should be visible to the evaluator. Ask what the existing report represents and what review is justified. Do not infer that nominally similar material names prove the evidence is interchangeable.
Questions before accepting a quotation
- What evaluation question is this cytotoxicity work intended to answer?
- Which device, material, batch and processing state do the samples represent?
- Which published reference and European amendment set will be used?
- What report, limitations and explanation of deviations are included?
- Who interprets the findings within the wider biological evaluation?
A fictional supplier-change decision
A device manufacturer changes the supplier of a polymer component. Both suppliers use the same broad material description, and the original file contains a cytotoxicity report. Procurement proposes to retain that report without further review because the component drawings are unchanged.
The biological evaluator receives the available material and processing differences and checks what the original report represents. The manufacturer asks for a documented rationale for using existing evidence or commissioning further work. This fictional example does not recommend a test strategy or reach a safety conclusion about either material.
Buy the document set
Separately listed amendment: EN ISO 10993-5:2009/A11:2025. Check the base-document inclusion, language, licence and seller's checkout terms.
Common buying questions
Is a cytotoxicity report the complete biological evaluation?
No. Its findings need justified interpretation within the device's wider evaluation.
Can a raw-material report represent every finished device?
Ask the evaluator to explain sample relevance and any limits. The supplied material and finished device are different evidence subjects.
Does the catalogue's publication status prove a regulatory route?
No. Have the responsible reviewer confirm the applicable regulatory basis separately from buying the test-method document.
Public catalogue sources checked on 7 October 2026. See other device-document guides in the standards directory.
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