ДСТУ EN ISO 10993-11:2022 Биологическая оценка медицинских изделий. Часть 11. Тесты на системную токсичность (EN ISO 10993-11:2018, IDT; ISO 10993-11:2017, IDT)



ДСТУ EN ISO 10993-11:2022
(EN ISO 10993-11:2018, IDT; ISO 10993-11:2017, IDT)

Біологічне оцінювання медичних виробів. Частина 11. Тести на системну токсичність

 

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

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

4.6 Route of exposure

4.7 Sample preparation

4.8 Dosing

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

5.3 Evaluation criteria

5.4 Final report

6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)

6.1 General

6.2 Study design

6.3 Evaluation criteri

6.4 Final report

Annex A (informative) Routes of administration

Annex В (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