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.
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 |
| ISO 8836:2019 | Suction catheters for use in the respiratory tract |
| ISO 639-1:2002 | Codes for the representation of names of languages — Part 1: Alpha-2 code |
| ISO 80601-2-87:2021 | Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
| ISO 10651-6:2004 | Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices |
| 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 |
| IEC TR 60878:2022 | Graphical symbols for electrical equipment in medical practice |
| ISO 80601-2-12:2023 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 80601-2-13:2022 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO 80601-2-84:2020 | Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| ISO 19223:2019 | Lung ventilators and related equipment — Vocabulary and semantics |
| ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| ISO 10651-3:1997 | Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| ISO 4135:2022 | Anaesthetic and respiratory equipment — Vocabulary |
| ISO/TR 21954:2018 | Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| IEC 60601-1-11:2015+AMD1:2020 CSV | 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 |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| 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 |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 CSV | 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 |
| ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications |
| IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 80601-2-79:2024 | Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
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