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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
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.
DocumentType |
Standard
|
Pages |
36
|
PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
Status |
Superseded
|
Standards | Relationship |
UNI EN ISO 10993-11 : 2009 | Identical |
ONORM EN ISO 10993-11 : 2009 | Identical |
ISO 10993-11:2017 | Identical |
NF EN ISO 10993-11 : 2009 | Identical |
UNE-EN ISO 10993-11:2009 | Identical |
SN EN ISO 10993-11 : 2009 | Identical |
I.S. EN ISO 10993-11:2009 | Identical |
NEN EN ISO 10993-11 : 2009 | Identical |
NBN EN ISO 10993-11 : 2009 | Identical |
BS EN ISO 10993-11:2009 | Identical |
NS EN ISO 10993-11 : 2009 | Identical |
EN ISO 10993-11:2009 | Identical |
SN 119800 : 1990 | BIOLOGICAL EVALUATION OF DENTAL MATERIALS |
ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ASTM F 619 : 2014 : REDLINE | Standard Practice for Extraction of Medical Plastics |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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