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INTERNATIONAL ISO
STANDARD 80601-2-67
Second edition
2020-10
Medical electrical equipment —
Part 2-67:
Particular requirements for basic
safety and essential performance of
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
Reference number
©
ISO 2020
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved
Contents Page
Foreword . v
Introduction . vi
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 . 7
201. 6 Classification of ME equipment and ME systems . 8
201. 7 * ME equipment identification, marking and documents . 8
201. 8 Protection against electrical hazards from ME equipment . 15
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 15
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 . 18
201. 13 Hazardous situations and fault conditions . 21
201. 14 Programmable electrical medical systems (PEMS) . 21
201. 15 Construction of ME equipment . 22
201. 16 ME systems . 22
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 22
201.101 Gas connections. 22
201.102 Requirements for parts and accessories . 23
201.103 Oxygen pressure regulators . 25
202 Electromagnetic disturbances – Requirements and tests . 25
202.4.3.1 * Configurations . 25
206 Usability . 26
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 27
Annex D (informative) Symbols on marking . 32
Annex AA (informative) Particular guidance and rationale . 33
Annex BB (informative) Reference to the IMDRF essential principles and labelling
guidances . 42
Annex CC (informative) Reference to the essential principles . 46
Annex DD (informative) Reference to the general safety and performance requirements . 49
Annex EE (informative) Terminology — Alphabetized index of defined terms . 53
Bibliography . 56
iv © ISO 2020 – All rights reserved
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
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 document 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 and IEC 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) or the
IEC list of patent declarations received (see http://patents.iec.ch).
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 80601-2-67:2014), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— clarified the accessibility of inlet and outlet connectors;
— formatted to provide a unique identifier for each requirement; and
— 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.
Introduction
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.
Most clinicians prescribe low flow oxygen therapy as continuous flow oxygen (CFO) delivery in l/min.
CFO systems deliver the flow of oxygen without regard for the patient’s breathing rate or pattern.
Outside of the institutional care setting, the provision of CFO therapy is often a significant expense and
can limit the mobility of a patient to the immediate vicinity of a stationary or fixed oxygen delivery
system. To support mobility, patients use CFO from portable liquid or compressed oxygen systems with
a limited storage capacity that can limit a patient’s time and activities while away from a stationary
oxygen supply.
Conserving equipment that delivers supplemental oxygen as a bolus conserves usage while allowing
satisfactory patient arterial oxygen saturation (SaO ) to be maintained during daily activities.
Conserving equipment delivers supplemental oxygen unlike CFO in that the therapy gas flow is delivered
only during the inspiratory phase of the breathing cycle, when it is most likely to reach the alveoli.
During both the expiratory and pause phase of the breathing cycle, the flow of supplemental oxygen is
stopped, minimizing waste. Because flow over time produces a volume, the bolus delivered by the
conserving equipment is typically represented as a volume of gas. Therapy using conserving equipment
versus CFO results in lower operating costs and longer ambulatory times for patients using the same
CFO storage capacity.
Operation of conserving equipment from various manufacturers might differ in the dose delivery
mechanism resulting in variations in oxygen therapy to the patient. The use of CFO numerical markings
for dose settings on conserving equipment might not directly correlate with CFO settings and might lead
to misinterpretation of gas delivery rates and volumes for a particular patient. This might result in
incorrect patient setup and therapy delivery over all breathing rates and patterns versus CFO. Because
of the differences in delivery, settings, and markings versus CFO therapy, conserving equipment use has
requirements for patient titration to determine the proper setting(s) needed to provide adequate SaO
levels for the patient breathing patterns.
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.
vi © ISO 2020 – All rights reserved
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.
INTERNATIONAL STANDARD ISO 80601-2-67:2020(E)
Medical electrical equipment —
Part 2-67:
Particular requirements for basic safety and essential
performance of oxygen conserving equipment
201.1 * Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
IEC 60601-1:2005+AMD1:2012, 1.1 is
...