ДСТУ EN 60601-2-39:2019 Изделия медицинские электрические. Часть 2-39. Дополнительные требования безопасности и основных рабочих характеристик аппаратуры для перитонеального диализа (EN 60601-2-39:2008, IDT;...



ДСТУ EN 60601-2-39:2019
(EN 60601-2-39:2008, IDТ; IEC 60601-2-39:2007, IDT)

Вироби медичні електричні. Частина 2-39. Додаткові вимоги щодо безпеки
та основних робочих характеристик апаратури для перитонеального діалізу

 

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

Contents

Foreword

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 of PD equipment

201.6 Classification of me equipment and me systems

201.7 Pd equipment identification, marking and documents

201.8 Protection against electrical hazards from pd 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

201.13 Hazardous situations and fault conditions

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

202 Electromagnetic compatibility - Requirements and tests

203 General requirements for radiation protection in diagnostic X-ray equipment

206 Usability

208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

209 Requirements for the reduction of environmental impacts

210 Process requirements for the development of physiologic closed-loop controllers

Annexes

Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures

Annex AA (informative) Particular guidance and rationale

Index of defined terms used in this particular standard