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INTERNATIONAL ISO
STANDARD 80601-2-69
Second edition
2020-11
Medical electrical equipment —
Part 2-69:
Particular requirements for the basic
safety and essential performance of
oxygen concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et les
performances essentielles des dispositifs concentrateurs d'oxygène
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – 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 . 4
201. 4 General requirements . 5
201. 5 General requirements for testing of ME equipment . 6
201. 6 Classification of ME equipment and ME systems . 6
201. 7 ME equipment identification, marking and documents . 7
201. 8 Protection against electrical hazards from ME equipment . 14
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 14
201. 10 Protection against unwanted and excessive radiation hazards . 16
201. 11 Protection against excessive temperatures and other hazards . 16
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201. 13 Hazardous situations and fault conditions for ME equipment . 25
201. 14 Programmable electrical medical systems (PEMS) . 25
201. 15 Construction of ME equipment . 25
201. 16 ME systems . 26
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 26
201.101 Outlet connector . 26
201.102 Requirements for parts and accessories . 27
201.103 Functional connection . 28
201.104 * Indication of duration of operation . 28
201.105 Integrated conserving equipment function . 29
202 Electromagnetic disturbances – Requirements and tests . 29
202.4.3.1 * Configurations . 29
206 Usability . 30
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 31
211.4.2.2 Environmental operating conditions . 31
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 32
Annex D (informative) Symbols on marking . 37
Annex AA (informative) Particular guidance and rationale . 39
Annex BB (informative) Reference to the IMDRF essential principles and labelling
guidances . 46
Annex CC (informative) Reference to the essential principles . 51
Annex DD (informative) Reference to the general safety and performance requirements . 55
Annex EE (informative) Terminology — alphabetized index of defined terms . 59
Bibliography . 62
iv © ISO 2020 – All rights reserved
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 D,
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 80601-2-69:2014), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— changes to the low oxygen concentration alarm condition;
— changes to the gas outlet connector;
— changes to the test method for the filter for the delivered gas;
— reformatting to provide a unique identifier for each requirement;
— harmonization with the ‘A2 project’ of the general standard.
A list of all parts in the ISO and 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 © ISO 2020 – All rights reserved
Introduction
Oxygen supplementation can be part of management of patients with chronic, acute-on-chronic or acute
respiratory disorders. The amount of supplemental oxygen depends on the individual patient’s needs
under various conditions. The managing healthcare team typically prescribes the endpoint of treatment,
for example a target value for oxygen saturation. The amount of supplemental oxygen can be controlled
by the flowrate.
The goal of long-term oxygen therapy is to keep the oxygen saturation above a target value in patients
that require supplemental oxygen. The flowrate should be adjusted for rest, exertion and sleep to meet
the individual patient’s needs under these various conditions. Ideally, the resting flowrate is adjusted to
maintain SpO greater than the target value as indicated by pulse oximetry.
Supplemental oxygen is supplied by various sources: medical gas pipeline systems, oxygen concentrators,
compressed gas cylinders and liquid oxygen reservoirs. Oxygen concentrators produce oxygen-enriched
air from room air for delivery to a patient requiring oxygen therapy. The most common oxygen
concentrator uses molecular sieve beds to filter and concentrate oxygen molecules from the ambient air,
generating oxygen concentrations of typically 90 % to 96 %. The main component of this type of oxygen
concentrator is the molecular sieve, which adsorbs nitrogen from air to produce a product gas, which is
a mixture of typically up to 95 % oxygen and 5 % of other gases. The periodic adsorbing and purging of
nitrogen is referred to as the pressure swing adsorption process.
Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and
oxygen from an oxygen concentrator.
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 particular document
or as noted: italic type; and
— 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 three numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.); and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— "should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;
— "may” is used to describe a permission (e.g., permissible way to achieve conformance with a
requirement or test;
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
viii © ISO 2020 – All rights reserved
INTERNATIONAL STANDARD ISO 80601-2-69:2020(E)
Medical electrical equipment
Part 2-69:
Particular requirements for the basic safety and
essential performance of oxygen concentrator equipment
201.1 * Scope, object and related st
...