AAMI ISO 10993-11 : 2006 : R2014

Name: AAMI ISO 10993-11 : 2006 : R2014
Brand: AAMI

Superseded

View Superseded by

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

Superseded date

02-21-2019

Published date

01-01-2014

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Superseded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	ANSI/AAMI/ISO 10993-11: 2017

Standards	Relationship
ISO 10993-11:2017	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