ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$301.00 NZD
|
|
| HardCopy |
$346.00 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
4.5.2 Number of groups
4.5.3 Treatment controls
4.6 Route of exposure
4.7 Sample preparation
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
4.10 Clinical observations
4.11 Clinical pathology
4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
5.2 Study design
5.2.1 Preparations
5.2.2 Experimental animals
5.2.3 Test conditions
5.2.4 Body weights
5.2.5 Clinical observations
5.2.6 Pathology
5.3 Evaluation criteria
5.3.1 General
5.3.2 Evaluation of results
5.4 Final report
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
6.2.3 Test conditions
6.2.4 Body weights
6.2.5 Clinical observations
6.2.6 Pathology
6.3 Evaluation criteria
6.3.1 General
6.3.2 Evaluation of results
6.4 Final report
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) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing
Annex G (informative) Information on material-mediated pyrogens
Annex H (informative) Subchronic rat — Dual routes of parenteral administration
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
BS EN ISO 10993-1:2020
Biological evaluation of medical devices, Evaluation and testing within a risk management process
-
BS EN ISO 10993-1:2020 - TC
Tracked Changes. Biological evaluation of medical devices, Evaluation and testing within a risk management process
-
BS EN ISO 10993-10:2023
Biological evaluation of medical devices, Tests for skin sensitization
-
BS EN ISO 10993-10:2023 - TC
Tracked changes. Biological evaluation of medical devices, Tests for skin sensitization
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
4.5.2 Number of groups
4.5.3 Treatment controls
4.6 Route of exposure
4.7 Sample preparation
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
4.10 Clinical observations
4.11 Clinical pathology
4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General
5.2 Study design
5.2.1 Preparations
5.2.2 Experimental animals
5.2.3 Test conditions
5.2.4 Body weights
5.2.5 Clinical observations
5.2.6 Pathology
5.3 Evaluation criteria
5.3.1 General
5.3.2 Evaluation of results
5.4 Final report
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
6.2.3 Test conditions
6.2.4 Body weights
6.2.5 Clinical observations
6.2.6 Pathology
6.3 Evaluation criteria
6.3.1 General
6.3.2 Evaluation of results
6.4 Final report
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) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing
Annex G (informative) Information on material-mediated pyrogens
Annex H (informative) Subchronic rat — Dual routes of parenteral administration
Bibliography