🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 10993-11:2018

BS EN ISO 10993-11:2018

$189.07

Biological evaluation of medical devices – Tests for systemic toxicity

Published By Publication Date Number of Pages
BSI 2018 46
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General considerations
4.1 General
4.2 Selection of animal species
4.3 Animal status
4.4 Animal care and husbandry
12 4.5 Size and number of groups
4.5.1 Size of groups
4.5.2 Number of groups
4.5.3 Treatment controls
13 4.6 Route of exposure
4.7 Sample preparation
4.8 Dosing
4.8.1 Test sample administration
4.8.2 Dosage volumes
14 4.8.3 Dosage frequency
4.9 Body weight and food/water consumption
4.10 Clinical observations
4.11 Clinical pathology
15 4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
16 5.2 Study design
5.2.1 Preparations
5.2.2 Experimental animals
5.2.3 Test conditions
17 5.2.4 Body weights
5.2.5 Clinical observations
5.2.6 Pathology
18 5.3 Evaluation criteria
5.3.1 General
5.3.2 Evaluation of results
5.4 Final report
20 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
21 6.2.3 Test conditions
6.2.4 Body weights
6.2.5 Clinical observations
6.2.6 Pathology
22 6.3 Evaluation criteria
6.3.1 General
23 6.3.2 ​Evaluation of results
6.4 Final report
24 Annex A (informative) Routes of administration
26 Annex B (informative) Dosage volumes
27 Annex C (informative) Common clinical signs and observations
28 Annex D (informative) Suggested haematology, clinical chemistry and urinalysis measurements
30 Annex E (informative) Suggested organ list for histopathological evaluation
32 Annex F (informative) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing
33 Annex G (informative) Information on material-mediated pyrogens
34 Annex H (informative) Subchronic rat — Dual routes of parenteral administration
36 Bibliography

Related products

BS EN ISO 10993-11:2018
$189.07