DIN EN ISO 80601-2-69 E : 2014
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)
Hardcopy , PDF
English
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
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