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DIN EN ISO 80601-2-69 E : 2014

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

National foreword
National Annex NA (informative) - Bibliography
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
Bibliography
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive
         93/42/EEC

Defines requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT.

DevelopmentNote
Supersedes DIN EN ISO 8359 E. (03/2015)
DocumentType
Standard
Pages
56
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 80601-2-69:2014 Identical
EN ISO 80601-2-69:2014 Identical

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IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
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