I.S. EN ISO 80601-2-74:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2- 74:2017)
Hardcopy , PDF
14-08-2021
English
08-03-2020
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.
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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 form 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 BREATHING SYSTEM connectors and ports
201.102 Requirements for the BREATHING SYSTEM and ACCESSORIES
201.103 LIQUID CONTAINER
201.104 FUNCTIONAL CONNECTION
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 (normative) * Determination of the accuracy of the displayed MEASURED GAS TEMPERATURE
Annex CC (normative) * Determination of the HUMIDIFICATION OUTPUT
Annex DD (normative) * Specific enthalpy calculations
Annex EE (normative) Removable temperature sensors and mating ports
Annex FF (normative) * Standard temperature sensor
Annex GG (informative) Saturation vapour pressure
Annex HH (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO 16142-1:2016
Annex II (informative) Terminology — Alphabetized index of defined terms
Bibliography
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a HUMIDIFIER, also hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES, the combination also hereafter referred to as ME SYSTEM.
| Committee |
CEN/TC 215
|
| 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:ISO 80369-2 |
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-74:2017 | Identical |
| EN ISO 80601-2-74:2020 | Identical |
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