I.S. EN ISO 80601-2-80:2024
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
Hardcopy , PDF
English
05-09-2024
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 Indication of duration of operation
201.105 Functional connection
201.106 Display loops
201.107 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
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
Bibliography
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
| DocumentType |
Standard
|
| Pages |
120
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 80601-2-80:2024 | Identical |
| ISO 80601-2-80:2024 | Identical |
| IEC 60601-1-3:2008 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
| ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.