ДСТУ EN ISO 14971:2022 Медицинские изделия. Руководство по управлению риском для медицинских изделий (EN ISO 14971:2019, IDT; ISO 14971:2019, IDT)

ДСТУ EN ISO 14971:2022
(EN ISO 14971:2019, IDT; ISO 14971:2019, IDT)

Вироби медичні. Настанови щодо управління ризиком щодо медичних виробів

 
   
 
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 requirements for risk management system

4.1 Risk management process

4.2 Management responsibilities

4.3 Competence of personnel

4.4 Risk management plan

4.5 Risk management file

5 Risk analysis

5.1 Risk analysis process

5.2 Intended use and reasonably foreseeable misuse

5.3 Identification of characteristics related to safety

5.4 Identification of hazards and hazardous situations

5.5 Risk estimation

6 Risk evaluation

7 Risk control

7.1 Risk control option analysis

7.2 Implementation of risk control measures

7.3 Residual risk evaluation

7.4 Benefit-risk analysis

7.5 Risks arising from risk control measures

7.6 Completeness of risk control

8 Evaluation of overall residual risk

9 Risk management review

10 Production and post-production activities

10.1 General

10.2 Information collection

10.3 Information review

10.4 Actions

Annex A (informative) Rationale for requirements

Annex В (informative) Risk management process for medical devices

Annex C (informative) Fundamental risk concepts

Bibliography