DIN EN ISO 10993-11:2009-08
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
Hardcopy , PDF
07-03-2021
English
01-01-2009
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
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.