ДСТУ EN 82304-1:2022 Программное обеспечение здоровья. Часть 1. Общие требования по безопасности продукции (EN 82304-1:2017, IDT; IEC 82304-1:2016, IDT)

ДСТУ EN 82304-1:2022
(EN 82304-1:2017, IDT; IEC 82304-1:2016, IDT)

Програмне забезпечення для здоров’я.
Частина 1. Загальні вимоги щодо безпеки продукції

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

Contents

Foreword

Introduction

1 Scope

1.1 Purpose

1.2 Field of application

1.3 Compliance

2 Normative references

3 Terms and definitions

4 HEALTH SOFTWARE PRODUCT requirements

4.1 General requirements and initial RISK ASSESSMENT

4.2 HEALTH SOFTWARE PRODUCT use requirements

4.3 VERIFICATION of HEALTH SOFTWARE PRODUCT use requirements

4.4 Updating HEALTH SOFTWARE PRODUCT use requirements

4.5 System requirements

4.6 VERIFICATION of system requirements

4.7 Updating HEALTH SOFTWARE PRODUCT system requirements

5 HEALTH SOFTWARE - Software life cycle processes

6 HEALTH SOFTWARE PRODUCT VALIDATION

6.1 VALIDATION plan

6.2 Performing VALIDATION

6.3 VALIDATION report

7 HEALTH SOFTWARE PRODUCT identification and ACCOMPANYING DOCUMENTS

7.1 Identification

7.2 ACCOMPANYING DOCUMENTS

8 Post-market activities for the HEALTH SOFTWARE PRODUCT

8.1 General

8.2 SOFTWARE MAINTENANCE

8.3 Re-VALIDATION

8.4 Post-market communication on the HEALTH SOFTWARE PRODUCT

8.5 Decommissioning and disposal of the HEALTH SOFTWARE PRODUCT

Annex A (informative) Rationale

Bibliography