Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity Ingestion-build-47182 900 MPa ≤ Rm ≤

900 MPa ≤ Rm ≤ 1 100 MPa

These Service Delivery guidelines are applicable to Very Small Entities (VSEs)

What is ISO 6551 - The fidelity and security of pulsed data cabled transmission systems about

Annex ZA (informative) - Clauses of this European Standard addressing essential requirements or other provisions of EU Directives

and class 4

Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity Ingestion-build-47182 900 MPa ≤ Rm ≤1 Scope This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential