I.S. EN ISO 80601-2-72:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
Hardcopy , PDF
English
01-01-2015
18-12-2023
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
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 Gas connections
201.102 Requirements for the VBS and
ACCESSORIES
201.103 Spontaneous breathing during loss
of power supply
201.104 Training
201.105 Indication of duration of operation
201.106 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATOR security
202 Electromagnetic disturbances - Requirements
and tests
206 Usability
208 General requirements, tests and guidance for alarm
systems in medical electrical equipment and
medical electrical systems
211 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) - Data interface requirements
Annex CC (informative) - Reference to the Essential
Principles
Annex DD (informative) - Alphabetized index of
defined terms used in this particular standard
Bibliography
Annex ZA (informative) - Relationship between this
Document and the Essential Requirements of
EU Directive 93/42/EEC
Pertains to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended for use in the home healthcare environment; - intended for use by a lay operator; and - intended for use with patients who are dependent on mechanical ventilation for their life support.
| DevelopmentNote |
Supersedes I.S. EN ISO 10651-2. (10/2015)
|
| DocumentType |
Standard
|
| Pages |
110
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-72:2015 | Identical |
| EN ISO 80601-2-72:2015 | Identical |
| UNE-EN ISO 80601-2-72:2015 | Equivalent |
| BS EN ISO 80601-2-72:2015 | Equivalent |
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