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BS EN ISO 10993-11:2018:2022 Edition

BS EN ISO 10993-11:2018:2022 Edition

$189.07

Biological evaluation of medical devices – Tests for systemic toxicity

Published By Publication Date Number of Pages
BSI 2022 46
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
7 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
10 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
14 Foreword
15 Introduction
17 1 Scope
2 Normative references
3 Terms and definitions
19 4 General considerations
4.1 General
4.2 Selection of animal species
4.3 Animal status
4.4 Animal care and husbandry
20 4.5 Size and number of groups
4.5.1 Size of groups
4.5.2 Number of groups
4.5.3 Treatment controls
21 4.6 Route of exposure
4.7 Sample preparation
4.8 Dosing
4.8.1 Test sample administration
4.8.2 Dosage volumes
22 4.8.3 Dosage frequency
4.9 Body weight and food/water consumption
4.10 Clinical observations
4.11 Clinical pathology
23 4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
24 5.2 Study design
5.2.1 Preparations
5.2.2 Experimental animals
5.2.3 Test conditions
25 5.2.4 Body weights
5.2.5 Clinical observations
5.2.6 Pathology
26 5.3 Evaluation criteria
5.3.1 General
5.3.2 Evaluation of results
5.4 Final report
28 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)
6.1 General
6.2 Study design
6.2.1 Preparations
6.2.2 Experimental animals
29 6.2.3 Test conditions
6.2.4 Body weights
6.2.5 Clinical observations
6.2.6 Pathology
30 6.3 Evaluation criteria
6.3.1 General
31 6.3.2 ​Evaluation of results
6.4 Final report
32 Annex A (informative) Routes of administration
34 Annex B (informative) Dosage volumes
35 Annex C (informative) Common clinical signs and observations
36 Annex D (informative) Suggested haematology, clinical chemistry and urinalysis measurements
38 Annex E (informative) Suggested organ list for histopathological evaluation
40 Annex F (informative) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing
41 Annex G (informative) Information on material-mediated pyrogens
42 Annex H (informative) Subchronic rat — Dual routes of parenteral administration
44 Bibliography

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BS EN ISO 10993-11:2018
$189.07