ДСТУ EN IEC 60601-2-1:2022 Изделия медицинские электрические. Часть 2-1. Дополнительные требования к базовой безопасности и основным характеристикам ускорителей электронов в диапазоне от 1 МэВ до 50 МэВ (EN I...



ДСТУ EN IEC 60601-2-1:2022
(EN IEC 60601-2-1:2021, IDT; IEC 60601-2-1:2020, IDT)
Вироби медичні електричні. Частина 2-1. Додаткові вимоги щодо базової
безпеки та основних характеристик прискорювачів електронів
у діапазоні від 1 МеВ до 50 МеВ

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

Contents

FOREWORD

INTRODUCTION

201.1 Scope, object and related standards

201.2 Normative references

201.3 Terms and definitions

201.4 General requirements

201.5 General requirements for testing me equipment

201.6 Classification of me equipment and me systems

201.7 Me equipment identification, marking and documents

201.8 Protection against electrical hazards from me equipment

201.9 Protection against mechanical hazards of me equipment and me systems

201.10 Protection against unwanted and excessive radiation hazards

201.11 Protection against excessive temperatures and other hazards

201.12 Accuracy of controls and instruments and protection against hazardous outputs

201.14 Programmable electrical medical systems (pems)

201.15 Construction of me equipment

201.16 Me systems

201.17 Electromagnetic compatibility of me equipment and me systems

201.101 * Electronic imaging devices (e.g. epid)

201.102 Date and time format

201.103 External monitoring devices

201.104 * Latency

201.105 Interfaces

201.106 Treatment plan retrieval

201.107 Recording of treatment delivery

201.108 Adaptive radiotherapy

201.109 Imaging dose delivery

201.110 Operation of me equipment from outside the facility

206 Usability

206.101 Usability of electron accelerators

Annexes

Annex В (informative) Sequence of testing

Annex AA (informative) Particular guidance and rationale

Annex BB (informative) Electronic imaging devices (e.g. epid)

Annex CC (informative) Latency and accuracy of dose delivery between control points

Annex DD (informative) Radiobiology considerations

Bibliography

Index of defined terms