I.S. EN ISO 80601-2-90:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
Hardcopy , PDF
English
25-10-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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 breathing system and accessories
201.103 * Indication of duration of operation
201.104 Functional connection
201.105 Power supply cords
201.106 Respiratory high-flow therapy 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 IMDRF essential principles and labelling guidances
Annex DD (informative) Reference to the essential principles
Annex EE (informative) Reference to the general safety and performance requirements
Annex FF (informative) Terminology — Alphabetized index of defined terms
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: — intended for use with patients who can breathe spontaneously; and — intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
| Committee |
ISO/TC 121
|
| DocumentType |
Standard
|
| Pages |
108
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO IMDRF/GRRP WG/N47:2018,IMDRF/GRRP WG/N52:2019
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 80601-2-90:2021 | Identical |
| EN ISO 80601-2-90:2021 | Identical |
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