Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
4.1 General
4.2 Selection of animal species
4.3 Animal status
4.4 Animal care and husbandry
4.5 Size and number of groups
4.6 Route of exposure
4.7 Sample preparation
4.8 Dosing
4.9 Body weight and food/water consumption
4.10 Clinical observations
4.11 Clinical pathology
4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
5.2 Study design
5.3 Evaluation criteria
5.4 Final report
6 Repeated exposure systemic toxicity (subacute, subchronic
and chronic systemic toxicity)
6.1 General
6.2 Study design
6.3 Evaluation criteria
6.4 Final report
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 Medical
Devices