Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity Ingestion-build-47182 Annex ZA (informative) - Clauses

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

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

BS EN 60191-6-21 on Mechanical standardization of semiconductor devices is useful for:

PD IEC TR 62059-11 deals with all types of static metering equipment for electrical energy measurement and load control

Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity Ingestion-build-47182 Annex ZA (informative) - Clauses1 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