AAMI ISO 10993-11 : 2006 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
01-01-2014
21-02-2019
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-11:2006
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
Defines requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
| Committee |
WG 07
|
| DevelopmentNote |
Supersedes AAMI 10993 11. (09/2009)
|
| DocumentType |
Standard
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10993-11:2017 | Identical |
| 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 |
Access your standards online with a subscription
-
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.