On this page
- Buy the published 2025 European edition
- Evaluation within risk management
- Compare evaluation and testing services
- Questions before accepting a laboratory offer
- Example: changing a patient-contact component
- Handle edition changes through a reasoned review
- Frequently asked buying questions
- Related guidance
- Explore more standards buying guides
Buy the published 2025 European edition
Evaluation within risk management
The public scope concerns biological evaluation within an ISO 14971 risk-management process, considering device constituents and tissue-device interactions. It addresses direct or indirect body contact in its specified context and device changes over the lifecycle. Infectious-agent risks and environmental impacts of decommissioning are excluded.
Prepare the device identity, intended use and construction information before asking for an evaluation quote. Ask the responsible evaluator what it needs about materials, processing and existing evidence. A material trade name alone may leave the service boundary too vague to price reliably.
Compare evaluation and testing services
| Assignment | Question for the buyer |
|---|---|
| Device description | Which finished device, version and contact context form the assessment basis? |
| Existing information | Who reviews available evidence and identifies unresolved questions? |
| Additional work | Who proposes and justifies any further evaluation or testing assignment? |
| Final report | What connects conclusions and limitations to the actual device baseline? |
The table is an original procurement aid. It does not select biological endpoints, tests or acceptance criteria. The responsible evaluation team must make those device-specific decisions using the applicable information and documents.
Questions before accepting a laboratory offer
- Does the quote include evaluation planning and evidence review, or only named tests?
- Which device construction and manufacturing information must the buyer supply?
- How are existing reports connected to the finished device?
- Who identifies and reviews gaps or uncertainties in the evidence?
- What happens if a material, processing step or supplier changes?
Send the same device description and evidence register to prospective providers. If a quote lists tests without explaining the wider assignment, ask how the test results will be interpreted and by whom. This prevents a completed testing order from leaving the evaluation responsibility unclear.
Example: changing a patient-contact component
A device manufacturer proposes a new supplier for a patient-contact component. The supplier sends a material certificate and an old test report. The buyer asks the evaluator to compare those records with the proposed finished component and its manufacturing information before commissioning further work.
The service order identifies the device baseline, evidence review deliverable and the process for resolving gaps. The final purchasing decision records the accepted supplier and the changes that need notification. The example does not establish biological safety or determine which tests are necessary.
Handle edition changes through a reasoned review
Keep older reports under their original edition and device identities. Ask the responsible evaluator how they relate to the current project basis and what review is appropriate. A newer document purchase is a reason to clarify the basis, not to relabel existing evidence as newly assessed.
Where the project also needs a regulatory conclusion, commission that separate review using current official information. Publication status and the date of a report do not alone answer the full product question. This guide verifies the document and assists service selection.
Frequently asked buying questions
Can I choose a test panel from this guide?
No. Provide the actual device, contact and evidence information to the responsible evaluator and request a justified proposal.
Is the current European reference dated 2026?
The verified published designation is EN ISO 10993-1:2025. Genorma's catalogue release is dated February 2026.
Does a material certificate finish the device evaluation?
Ask the evaluator what that certificate identifies and how it relates to the finished device. Its existence alone does not define the complete evaluation.
Related guidance
Read device risk management buying and medical quality-system purchasing.
Explore more standards buying guides
Browse standards by reference and subject to compare related document choices.