ДСТУ EN 45502-1:2019 Имплантаты хирургические. Устройства медицинские активные, которые имплантируют. Часть 1. Общие требования насчет безопасности, маркировки и информации, что предоставляет производитель (E...

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(ДП «УкрНДНЦ»))

Наказ від 20.12.2019 № 456

EN 45502-1:2015

Implants for surgery - Active implantable medical devices -
Part 1: General requirements for safety, marking
and for information to be provided by the manufacturer

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN 45502-1:2019
(EN 45502-1:2015, IDT)

Імплантати хірургічні. Пристрої медичні активні, які імплантують.
Частина 1. Загальні вимоги щодо безпеки, маркування
та інформації, що надає виробник

З наданням чинності від 2020–01–01

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Symbols and abbreviations (optional)

5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES

6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES

7 General arrangement of the packaging

8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES

9 MARKINGS on the SALES PACKAGING

10 Construction of the SALES PACKAGING

11 MARKINGS on the STERILE PACK

12 Construction of the NON-REUSABLE PACK

13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE

14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE

15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE

16 Protection from HARM to the patient caused by electricity

17 Protection from HARM to the patient caused by heat

18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE

19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE

20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators

21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields applied directly to the patient

22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous medical treatments

23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces

24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge

25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric pressure changes

26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature changes

27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing radiation

28 Accompanying documentation

Annex A (informative) General guidance and rationale

Annex ZA (normative)

Annex ZZ (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices

Bibliography