ДСТУ EN ISO 80601-2-69:2019 Медицинское электрооборудование. Часть 2-69. Особые требования по базовой безопасности и основным характеристикам кислородного концентратора и связанного с ним оборудования (EN ISO...

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EN ISO 80601-2-69:2014

Medical electrical equipment —
Part 2-69: Particular requirements for basic safety
and essential performance of oxygen concentrator equipment

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 80601-2-69:2019
(EN ISO 80601-2-69:2014, IDT; ISO 80601-2-69:2014, IDT)

Медичне електрообладнання.
Частина 2-69. Особливі вимоги щодо базової безпеки
та основних характеристик кисневого концентратора
та пов’язаного з ним обладнання

З наданням чинності від 2020–01–01

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 of 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

201.13 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

201.101 Outlet connector

201.102 Requirements for parts and ACCESSORIES

201.103 SIGNAL INPUT/OUTPUT PART

201.104 Indication of duration of operation

201.105 Integrated CONSERVING EQUIPMENT

202 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

206 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability

208 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

211 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS

Annex D (informative) Symbols on marking

Annex AA (informative) Particular guidance and rationale

Annex BB (informative) Reference to the Essential Principles