ДСТУ CEN ISO/TR 24971:2022 Изделия медицинские. Руководства по применению (CEN ISO/TR 24971:2020, IDT; ISO/TR 24971:2020, IDT)



ДСТУ CEN ISO/TR 24971:2022
(CEN ISO/TR 24971:2020, IDT; ISO/TR 24971:2020, IDT)

Вироби медичні. Настанови щодо застосування

 
   
 
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

7.2 Implementation of risk control measures

7.3 Residual risk evaluation

7.4 Benefit-risk analysis

7.5 Risks arising from risk control measure

7.6 Completeness of risk control

8 Evaluation of overall residual risk

8.1 General considerations

8.2 Inputs and other considerations

8.3 Possible approaches

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) Identification of hazards and characteristics related to safety

Annex В (informative) Techniques that support risk analysis

Annex C (informative) Relation between the policy, criteria for risk acceptability, risk control and risk evaluation

Annex D (informative) Information for safety and information on residual risk

Annex E (informative) Role of international standards in risk management

Annex F (informative) Guidance on risks related to security

Annex G (informative) Components and devices designed without using ISO 14971

Annex H (informative) Guidance for in vitro diagnostic medical devices

Bibliography