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DIN EN ISO 10993-11 E : 2009

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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
Current

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DIN EN ISO 7199 E : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
DIN EN ISO 8637 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
DIN EN ISO 3826-4 E : 2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)

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
DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)

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