ISO 10993-11:2017-09

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

German title: Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität
Publication date: 2017-09
Original language: English
Pages: 29

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Publication date: 2017-09
Original language: English
Pages: 29

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Content
ICS
Replacement amendments
Cooperation at DIN

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Content

Content (en)

Foreword
Introduction
Scope
Normative references
Terms and definitions
General considerations
- General
- Selection of animal species
- Animal status
- Animal care and husbandry
- Size and number of groups
  - Size of groups
  - Number of groups
  - Treatment controls
- Route of exposure
- Sample preparation
- Dosing
  - Test sample administration
  - Dosage volumes
  - Dosage frequency
- Body weight and food/water consumption
- Clinical observations
- Clinical pathology
- Anatomic pathology
- Study designs
- Quality of investigation
Acute systemic toxicity
- General
- Study design
  - Preparations
  - Experimental animals
  - Test conditions
  - Body weights
  - Clinical observations
  - Pathology
- Evaluation criteria
  - General
  - Evaluation of results
- Final report
Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)
- General
- Study design
  - Preparations
  - Experimental animals
  - Test conditions
  - Body weights
  - Clinical observations
  - Pathology
- Evaluation criteria
  - General
  - Evaluation of results
- Final report
Routes of administration (informative)
- General
- Dermal
- Implantation
- Inhalation
- Intradermal
- Intramuscular
- Intraperitoneal
- Intravenous
- Oral
- Subcutaneous
Dosage volumes (informative)
- General
  - Dosage volume references
Common clinical signs and observations (informative)
Suggested haematology, clinical chemistry and urinalysis measurements (informative)
- Haematology
- Clinical chemistry
- Urinalysis (timed collection, e.g. 16 h to 24 h)
Suggested organ list for histopathological evaluation (informative)
Organ list for limited histopathology for medical devices subjected to systemic toxicity testing (informative)
- General
- Procedure
Information on material-mediated pyrogens (informative)
Subchronic rat — Dual routes of parenteral administration (informative)
- General
  - Procedure
  - Dosage volume and frequency justification
Bibliography

ICS

11.100.20

Replacement amendments

This document replaces ISO 10993-11:2006-08 .

Cooperation at DIN

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