Biocompatibility: Biological evaluation of medical devices

 ISO 10993-1  

Evaluation and testing within a risk management system

 ISO 10993-2  

Animal welfare requirements

 ISO 10993-3  

Tests for genotoxicity, carcinogenicity and reproductive toxicity

 ISO 10993-4  

Selection of tests for interactions with blood

 ISO 10993-5  

Tests for in vitro cytotoxicity

 ISO 10993-6  

Tests for local effects after implantation

 ISO 10993-7  

Ethylene oxide sterilization residuals

 ISO 10993-8

Selection and qualification of reference materials for biological tests

 ISO 10993-9  

Framework for identification and quantification of potential degradation products

 ISO 10993-10  

Tests for irritation and skin sensitization

 ISO 10993-11  

Tests for systemic toxicity

 ISO 10993-12  

Sample preparation and reference materials

 ISO 10993-13  

Identification and quantification of degradation products from polymeric medical devices

 ISO 10993-14  

Identification and quantification of degradation products from ceramics

 ISO 10993-15  

Identification and quantification of degradation products from metals and alloys

 ISO 10993-16  

Toxicokinetic study design for degradation products and leachables

 ISO 10993-17  

Establishment of allowable limits for leachable substances

 ISO 10993-18  

Chemical characterization of materials

 ISO 10993-19  

Physico-chemical, morphological and topographical characterization of materials

 ISO 10993-20  

Principles and methods for immunotoxicology testing of medical devices

Source:  www.beuth.de/en