DIN EN ISO 10993-11 E : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Acute systemic toxicity
6 Repeated exposure systemic toxicity (subacute, subchronic
  and chronic systemic toxicity)
Annex A (informative) - Routes of administration
Annex B (informative) - Dosage volumes
Annex C (informative) - Common clinical signs and observations
Annex D (informative) - Suggested haematology, clinical chemistry
                        and urinalysis measurements
Annex E (informative) - Suggested organ list for histopathological
                        evaluation
Annex F (informative) - Information on material-mediated pyrogens
Bibliography
Annex ZA (informative) - Relationship between this European Standard
                         and the Essential Requirements of EU
                         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
                         Standard and the Essential Requirements of
                         EU Directive 90/385/EEC on Active Implantable
                         Devices
National Annex NA (informative) - Bibliography

Specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.