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AAMI 10993 11 2017

AAMI 10993 11 2017

$115.49

ANSI/AAMI/ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity

Published By Publication Date Number of Pages
AAMI 2017 38
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This third edition cancels and replaces the second edition (ISO 10993-11:2006), which has been technically revised

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 10993-11:2017; Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Committee representation
8 Background of ANSI/AAMI adoption of ISO 10993-11:2017
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
13 4 General considerations
4.1 General
4.2 Selection of animal species
4.3 Animal status
4.4 Animal care and husbandry
4.5 Size and number of groups
4.5.1 Size of groups
14 Table 1—Recommended minimum group sizes
4.5.2 Number of groups
4.5.3 Treatment controls
4.6 Route of exposure
4.7 Sample preparation
15 4.8 Dosing
4.8.1 Test sample administration
4.8.2 Dosage volumes
4.8.3 Dosage frequency
4.9 Body weight and food/water consumption
16 4.10 Clinical observations
4.11 Clinical pathology
4.12 Anatomic pathology
17 Table 2—Summary of observations
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
5.2 Study design
5.2.1 Preparations
18 5.2.2 Experimental animals
5.2.2.1 Selection of species
5.2.2.2 Number and sex
5.2.2.3 Housing and feeding conditions
5.2.3 Test conditions
5.2.3.1 Dose levels
5.2.3.2 Procedure
5.2.4 Body weights
5.2.5 Clinical observations
19 5.2.6 Pathology
5.2.6.1 Clinical pathology
5.2.6.2 Gross pathology
5.2.6.3 Histopathology
5.3 Evaluation criteria
5.3.1 General
20 5.3.2 Evaluation of results
5.4 Final report
21 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)
6.1 General
22 6.2 Study design
6.2.1 Preparations
6.2.2 Experimental animals
6.2.2.1 Selection of species
6.2.2.2 Number and sex
6.2.2.3 Housing and feeding conditions
6.2.3 Test conditions
6.2.3.1 Dose levels
6.2.3.2 Procedure
6.2.4 Body weights
6.2.5 Clinical observations
23 6.2.6 Pathology
6.2.6.1 Clinical pathology
6.2.6.2 Gross pathology
6.2.6.3 Histopathology
24 6.3 Evaluation criteria
6.3.1 General
6.3.2 Evaluation of results
6.4 Final report
25 Annex A (informative) Routes of administration
A.1 General
A.2 Dermal
A.3 Implantation
A.4 Inhalation
A.5 Intradermal
A.6 Intramuscular
A.7 Intraperitoneal
26 A.8 Intravenous
A.9 Oral
A.10 Subcutaneous
27 Annex B (informative) Dosage volumes
B.1 General
Table B.1—Maximum single dosage volumes (ml/kg) for test sample administration
B.2 Dosage volume references
28 Annex C (informative) Common clinical signs and observations
Table C.1—Common clinical signs and observations
29 Annex D (informative) Suggested haematology, clinical chemistry and urinalysis measurements
D.1 Haematology
D.2 Clinical chemistry
30 D.3 Urinalysis (timed collection, e.g. 16 h to 24 h)
31 Annex E (informative) Suggested organ list for histopathological evaluation
33 Annex F (informative) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing
F.1 General
F.2 Procedure
Table F.1—Organ list for limited histopathology
34 Annex G (informative) Information on material-mediated pyrogens
35 Annex H (informative) Subchronic rat—Dual routes of parenteral administration
H.1 General
Table H.1—Recommended dosing parameters
H.2 Procedure
H.3 Dosage volume and frequency justification
H.3.1 Intravenous
H.3.2 Intraperitoneal
37 Bibliography

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AAMI 10993 11 2017
$115.49