UNI EN ISO 10993-11 : 2009

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
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
Bibliography

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