|
INTERNATIONAL ISO
STANDARD 80601-2-74
Second edition
2021-07
Medical electrical equipment —
Part 2-74:
Particular requirements for basic
safety and essential performance of
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d'humidification
respiratoire
Reference number
©
ISO 2021
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
Contents Page
Foreword . v
Introduction . vii
201.1 Scope, object and related standards. 1
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 8
201.5 General requirements for testing of ME equipment . 11
201.6 Classification of ME equipment and ME systems . 12
201.7 ME equipment identification, marking and documents . 13
201.8 Protection against electrical hazards form ME equipment . 20
201.9 Protection against mechanical hazards of ME equipment and ME systems. 20
201.10 Protection against unwanted and excessive radiation hazards . 21
201.11 Protection against excessive temperatures and other hazards . 21
201.12 Accuracy of controls and instruments and protection against hazardous outputs
.......................................................................................................................................................... 24
201.13 Hazardous situations and fault conditions for ME Equipment . 30
201.14 Programmable electrical medical systems (PEMS) . 31
201.15 Construction of ME equipment . 32
201.16 ME systems . 32
201.16.2 Accompanying documents of an ME system . 32
201.17 Electromagnetic compatibility of ME equipment and ME systems . 32
201.101 Breathing system connectors and ports . 33
201.102 Requirements for the breathing system and accessories . 35
201.103 Liquid container . 36
201.104 Functional connection . 36
202 Electromagnetic disturbances — Requirements and tests . 37
206 Usability . 38
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 39
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 39
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems . 40
Annex D (informative) Symbols on marking . 45
Annex AA (informative) Particular guidance and rationale . 47
Annex BB (normative) * Determination of the accuracy of the displayed measured gas
temperature . 64
Annex CC (normative) * Determination of the humidification output . 66
Annex DD (normative) * Specific enthalpy calculations . 71
Annex EE (normative) Removable temperature sensors and mating ports . 73
Annex FF (normative) * Reference temperature sensor . 77
Annex GG (informative) Saturation vapour pressure . 80
Annex HH (informative) Reference to the IMDRF essential principles and labelling
guidances . 81
Annex II (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO 16142-1:2016 . 85
Annex JJ (informative) Reference to the general safety and performance requirements
.......................................................................................................................................................... 88
Annex KK (informative) Terminology — Alphabetized index of defined terms . 91
Bibliography . 95
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D,
Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80601-2-74:2017), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— harmonization with the ‘A2 project’ of the general standard;
— harmonization with ISO 20417;
— addition of category 3 for respiratory high-flow therapy equipment;
— modification of requirements for humidification output of category 2 humidifiers;
— addition of requirements for maximum temperature in normal use;
— addition of requirements for static and dynamic temperature stability;
— addition of requirements for low humidification output alarm condition;
— modification of audible acoustic energy test procedure;
— modification of thermal requirements for applied parts;
— modification of measured gas temperature test procedure;
— enlarged the ØW dimension of the temperature sensor port; and
— modification of humidification output test procedure.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC
websites.
Any feedback or questions on this document should be directed to the user’s national standards body.
A complete listing of these bodies can be found at www.iso.org/members.html.
vi
Introduction
This document specifies requirements for respiratory humidifying equipment intended for use on
patients in home healthcare environment and in healthcare facilities. Humidifiers are used to raise the
water content of gases delivered to patients. Gases available for medical use do not contain sufficient
moisture and can damage or irritate the respiratory tract or desiccate secretions of patients whose
upper airways have been bypassed. Inadequate humidity in the inspired gas can cause drying of the
upper airway, or desiccation of tracheo-bronchial secretions in the tracheal or tracheostomy tube,
[25] [38]
which can cause narrowing or even obstruction of the airway . Heat is employed to increase the
water output of the humidifier.
In addition, many humidifiers utilize heated breathing tubes in order to increase operating efficiency and
reduce water loss (condensate) as well as heat loss in the breathing tube. Ventilator and anaesthesia
breathing tubes in common use might not withstand the heat generated by humidifiers and breathing
tube heating mechanisms.
Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically heated
breathing tubes. However, since different manufacturers have used the same electrical connector for
different power outputs, electrically heated breathing tubes can be physically, but not electrically,
interchangeable. Use of improper electrically heated breathing tubes has caused overheating, circuit
melting, patient and operator burns and fires. It was not found practical to specify the interface
requirements for electrical connectors to ensure compatibility between humidifiers and breathing tubes
produced by different manufacturers.
Since the safe use of a humidifier depends on the interaction of the humidifier with its many accessories,
this document sets total system performance requirements up to the patient-connection port. These
requirements are applicable to accessories such as breathing tubes (both heated and non-heated),
temperature sensors and equipment intended to control the environment within these breathing tubes.
Humidification can also be used by respiratory support ME equipment to increase patient comfort and
compliance with the therapy. Examples are obstructive sleep apnoea and nasal high-flow therapy
equipment. The humidification output requirements of such ME equipment is less demanding as the
patient’s upper airway is not bypassed.
Humidifiers are commonly used with air and air-oxygen mixtures and any humidifier should be able to
operate with these gases. Care should be taken if using other gas mixes such as helium-oxygen mixtures,
as the different physical and thermal properties of these gases may disturb the operation of the
humidifier.
In this document, the following print types are used:
— Requirements and definitions: roman type;
— Test specifications and terms defined in Clause 3 of the general standard, in this document or as noted:
italic type;
— Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
In referring to the structure of this document, the term
— “clause” means one of the five numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201
...