Reference details
- Reference
- EN ISO 10993-13:1998
- Official title
- Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
- Organisation
- CEN
- Publisher status in source
- WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.
Product research routes
- Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
- Chemicals, plastics and rubber
Substance identity, material properties, sampling and analytical methods across chemical and polymer products.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
- Substance and formulation identity
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Legal citation
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