I.S. EN ISO 80601-2-80:2019&LC:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
Hardcopy , PDF
25-10-2024
English
07-10-2019
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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 for ME EQUIPMENT
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 Ventilatory support equipment 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) Terminology — Alphabetized index of defined terms
Bibliography
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: — intended for use in the HOME HEALTHCARE ENVIRONMENT; — intended for use by a LAY OPERATOR; — intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for TRANSIT‐OPERABLE use; — not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.
| Committee |
TC 121
|
| DevelopmentNote |
CORRECTION VERSION IS AVAILABLE NOW FOR THIS STANDARD
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO ISO 80601-2-84,IEC 80601-2-70:2015,ISO 80369-2 CORRECTION VERSION IS AVAILABLE NOW FOR THIS STANDARD
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 80601-2-80:2018 | Identical |
| EN ISO 80601-2-80:2019 | Identical |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
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