ISO 80601-2-70:2015

Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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INTERNATIONAL ISO
STANDARD 80601-2-70
First edition
2015-01-15
Medical electrical equipment —
Part 2-70:
Particular requirements for basic safety
and essential performance of sleep
apnoea breathing therapy equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les
performances essentielles de l'équipement de thérapie respiratoire pour
l'apnée du sommeil
Reference number
©
ISO 2015
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©  ISO 2015
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Contents Page
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards. 1
201.1.1 Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 6
201.4.3 ESSENTIAL PERFORMANCE . 6
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 6
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
201.5 General requirements for testing of ME EQUIPMENT . 6
201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT . 7
201.5.101.1 Gas flowrate and pressure specifications . 7
201.5.101.2 SLEEP APNOEA BREATHING THERAPY EQUIPMENT testing errors . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.7.1.2 Legibility of markings . 7
201.7.2.4.101 Additional requirements for ACCESSORIES . 7
201.7.2.13.101 Additional requirements for physiological effects . 7
201.7. .17.101 Additional requirements for protective packaging . 8
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts . 8
201.7.4.3 Units of measurement . 8
201.7.9.1 Additional general requirements . 9
201.7.9.2.1.101 Additional general requirements . 9
201.7.9.2.2.101 Additional requirements for warnings and safety notices . 9
201.7.9.2.9.101 Additional requirements for operating instructions . 10
201.7.9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
material . 10
201.7.9.3.1.101 Additional general requirements . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.9.6.2.1.101 Additional requirements for audible acoustic energy . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT . 13
201.11.6.4 Leakage . 13
201.11.8 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT . 14
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14
201.12.1 Accuracy of controls and instruments . 14
201.12.1.101 Stability of static AIRWAY PRESSURE ACCURACY (long-term accuracy) . 14
201.12.1.102 Stability of dynamic AIRWAY PRESSURE ACCURACY (short-term accuracy) . 15
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201.12.1.102.1 CPAP mode .15
201.12.1.102.2 BI-LEVEL POSITIVE AIRWAY PRESSURE mode .17
201.12.1.103 Maximum flowrate .19
201.12.4 Protection against hazardous output .20
201.12.4.101 Measurement of AIRWAY PRESSURE .20
201.12.4.102 MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .20
201.12.4.103 CO rebreathing.20
201.13 HAZARDOUS SITUATIONS and fault conditions .21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .21
201.15 Construction of ME EQUIPMENT .21
201.15.101 Mode of operation.21
201.16 ME SYSTEMS .21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21
201.17.101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .21
201.101 BREATHING GAS PATHWAY connectors .21
201.101.1 General .21
201.101.2 Other named ports .22
201.101.2.1 PATIENT-CONNECTION PORT .22
201.101.2.2 GAS OUTPUT PORT .22
201.101.2.3 FLOW-DIRECTION-SENSITIVE COMPONENTS .22
201.101.2.4 Ancillary port .22
201.101.2.5 Monitoring probe port .22
201.102 Requirements for the BREATHING GAS PATHWAY and ACCESSORIES .23
201.102.1 General .23
201.102.2 Labelling .23
201.102.3 Humidification .23
201.102.4 BREATHING SYSTEM FILTER (BSF) .23
201.103 FUNCTIONAL CONNECTION .23
201.103.1 General .23
201.103.2 FUNCTIONAL CONNECTION to support remote supervision .23
201.104 Training .24
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests .24
202.4.3.1 Compliance criteria .24
202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS .24
202.8.1.101 Additional general requirements .24
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability .25
208 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 .25
211 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 .25
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS .26
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Annex D (informative) Symbols on marking . 30
Annex AA (informative) Particular guidance and rationale . 31
Annex BB (informative) Data interface requirements . 35
Annex CC (informative) Reference to the Essential Principles . 39
Bibliography . 41
Alphabetized index of defined terms used in this particular standard . 43

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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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO/IEC 80601-2-70 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic
and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and Technical
Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
This first edition of ISO 80601-2-70 cancels and replaces the second edition of ISO 17510-1:2007. This
edition of ISO 80601-2-70 constitutes a technical revision of ISO 17510-1:2007 and includes an alignment
with third edition of IEC 60601-1 and IEC 60601-1-11.
The most significant changes are the following modifications:
 identification of ESSENTIAL PERFORMANCE for SLEEP APNOEA BREATHING THERAPY EQUIPMENT and its
ACCESSORIES;
and the following additions:
 tests for therapy performance; and
 new symbols.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
 Requirements and definitions: roman type.
 Test specifications: italic type.
 Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative
text of tables is also in a smaller type.
 TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In referring to the structure of this standard, the term
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 "clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
 “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
2. For the purposes of this standard, the auxiliary verb:
 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
 “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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.
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
this publication not be adopted for mandatory implementation nationally earlier than 3 years from the date of
publication for equipment newly designed and not earlier than 5 years from the date of publication for
equipment already in production.
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Introduction
Sleep apnoea is a chronic medical condition where the PATIENT repeatedly stops breathing during sleep.
These episodes typically last 10 s or more and cause the oxygen levels in the blood to drop. It can be caused
by obstruction of the upper airway (obstructive sleep apnoea or OSA) or by a failure of the brain to initiate a
breath (central sleep apnoea).
NOTE SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for the treatment of obstructive sleep apnoea and not
central sleep apnoea.
Sleep apnoea, if untreated, can cause and worsen other medical conditions, including hypertension, heart
failure and diabetes .
Hypopnoea refers to a transient reduction of airflow, often while the PATIENT is asleep, that lasts for at least
10 s, shallow breathing, or an abnormally low respiratory rate. Hypopnoea is less severe than apnoea. It also
results in decreased air movement into the lungs and can cause oxygen levels in the blood to drop. It is
commonly due to partial obstruction of the upper airway. [16]
Awareness of the RISKS associated with sleep apnoea has grown significantly. As a result, the use of SLEEP
APNOEA BREATHING THERAPY EQUIPMENT to treat both sleep apnoea and hypopnoea has become common.
This document covers BASIC SAFETY and ESSENTIAL PERFORMANCE requirements needed to protect PATIENTS in
the use of this ME EQUIPMENT.
ISO 80601-2-70 covers SLEEP APNOEA BREATHING THERAPY EQUIPMENT for PATIENT use. ISO 17510 applies to
MASKS and ACCESSORIES used to connect SLEEP APNOEA BREATHING THERAPY EQUIPMENT to the PATIENT. Figure
AA.1 shows this diagrammatically.

source: http://sleepdisorders.about.com/od/glossary/g/Sleep_Apnea.htm
Figures in square brackets refer to the Bibliography.
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INTERNATIONAL STANDARD ISO 80601-2-70:2015(E)

Medical Electrical Equipment —
Part 2-70:
Particular requirements for basic safety and essential
performance of sleep apnoea breathing therapy equipment
201.1 Scope, object and related standards
IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows:
201.1.1 * Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA
BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of
PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the
respiratory tract of the PATIENT. SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for use in the HOME
HEALTHCARE ENVIRONMENT by LAY OPERATORS as well as in professional healthcare institutions.
This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with
neonates.
This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are
not dependent on mechanical ventilation.
This particular standard is not applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who
are dependent on mechanical ventilation such as PATIENTS with central sleep apnoea.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES
can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.
MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy are additionally
3)
addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only,
the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the
general standard.
NOTE 4 See also 4.2 of the General Standard.

3) To be published.
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This particular standard is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency
[16]
oscillatory ventilators (HFOVs).
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for critical
care ventilators for ventilator-dependent PATIENTS which are given in ISO 80601-2-12.
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for
anaesthetic applications which are given in IEC 80601-2-13.
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home
4)
care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2 .
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for
5)
emergency and transport which are given in ISO 10651-3 .
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home-
6)
care ventilatory support devices which are given in ISO 10651-6 .
This particular standard is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for SLEEP APNOEA BREATHING THERAPY EQUIPMENT [as defined in 201.3.212].
201.1.3 Collateral standards
IEC 60601-1:2005+A1:2012, 1.3 applies with the following addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and 201.2 of this particular standard.
IEC 60601-1-3:2008 does not apply.
201.1.4 Particular standards
IEC 60601-1:2005+A1:2012, 1.4 is replaced by:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT under
consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard or the collateral standards.
For brevity, IEC 60601-1:2005+A 1:2012 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.

4) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at
which time it will be replaced by ISO 80601-2-xx.
5) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 at which time it will be replaced
by ISO 80601-2-xx.
6) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at
which time it will be replaced by ISO 80601-2-xx.
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The numbering of clauses and subclauses of this particular standard corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the
collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4
of the IEC 60601-1-2 collateral standard, 208.4 in this particular standard addresses the content of Clause 4
of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified
by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is
replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the general
standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this particular standard.
Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101,
additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx,
where “xx” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 211 for IEC 60601-1-11, etc.
The term "this standard" is used to make reference to the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the section, clause or
subclause of the general standard or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
The following referenced documents are indispensable for the application of this document. The way in which
these referenced documents are cited in normative requirements determines the extent (in whole or in part) to
which they apply. For dated references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments) applies.
NOTE Informative references are listed in the Bibliography beginning on page 41.
IEC 60601-1:2005+A1:2012, Clause 2 applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic compatibility – Requirements and tests
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 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
+Amendment 1:2013
IEC 60601-1-8:2006, 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
+Amendment 1:2012
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7)
IEC 60601-1-11:— (Ed 2), 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
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Cones and sockets
ISO 7000:2012, Graphical symbols for use on equipment — Registered symbols
8)
ISO 8185:2007 , Humidifiers for medical use — General requirements for humidification systems
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
EN 15986:2011, Symbol for use in the labelling of medical devices — Requirements for labelling of medical
devices containing phthalates
9)
ISO 17510:— , Sleep apnoea breathing therapy masks and application accessories
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
Amendment 1:2012
IEC 62366:2007, Medical devices — Application of usability engineering to medical devices

+Amendment 1:2014
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
7)
To be published.
8)
In the future, this standard is expected to be harmonized with the IEC 60601-1:2005+A1:2012 and
IEC 60601-1-11:2010 at which time it will be replaced by ISO 80601-2-74.
9)
To be published.
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201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8185:2007, ISO 23328-2:2002,
IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010+A1:2013, IEC 62366:2007+A1:2014,
ISO 4135:2001 and the following apply.
NOTE An index of defined terms is found beginning on page 43.
Addition:
201.3.201
AIRWAY PRESSURE
P
aw
pressure at the PATIENT-CONNECTION PORT
201.3.202
AIRWAY PRESSURE ACCURACY
degree of correspondence between the pressure set on the SLEEP APNOEA BREATHING THERAPY EQUIPMENT and
the actual (true) AIRWAY PRESSURE
201.3.203
BI-LEVEL PAP
BI-LEVEL POSITIVE AIRWAY PRESSURE
two therapeutic positive pressure levels at the PATIENT-CONNECTION PORT during the respiratory cycle
201.3.204
BREATHING GAS PATHWAY
pathway through which gas flows at respiratory pressures between the gas INTAKE PORT and the PATIENT-
CONNECTION PORT
201.3.205
CPAP
CONTINUOUS POSITIVE AIRWAY PRESSURE
therapeutic CONTINUOUS POSITIVE AIRWAY PRESSURE during the respiratory cycle
201.3.206
FLOW-DIRECTION-SENSITIVE COMPONENT
component or ACCESSORY through which gas flow has to be in one direction only for proper functioning or
PATIENT safety
[SOURCE: ISO 4135:2001, definitions 3.1.7, modified–Added ‘or ACCESSORY’ and replaced ‘must’ with ‘has
to’.]
201.3.207
INTAKE PORT
port through which gas is drawn by SLEEP APNOEA BREATHING THERAPY EQUIPMENT
[SOURCE: ISO 4135:2001, definitions 3.2.11, modified–Replaced a ventilator or by a PATIENT with SLEEP
APNOEA BREATHING THERAPY EQUIPMENT.]
201.3.208
MAXIMUM LIMITED PRESSURE
P
LIM max
highest AIRWAY PRESSURE during NORMAL USE or under SINGLE FAULT CONDITION
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
201.3.209
MONITORING EQUIPMENT
ME EQUIPMENT or part that continuously or continually measures and continuously or continually or on
OPERATOR-demand indicates the value of a variable to the OPERATOR
201.3.210
PROTECTION DEVICE
part or function of ME EQUIPMENT that, without intervention by the OPERATOR, protects the PATIENT from
hazardous output due to incorrect delivery of energy or substances
201.3.211
SELF-ADJUSTING
automatically adjusting the pressure in the BREATHING GAS PATHWAY according to the PATIENT'S needs during
use
201.3.212
SLEEP APNOEA BREATHING THERAPY EQUIPMENT
ME EQUIPMENT intended to alleviate the symptoms of a PATIENT who suffers from sleep apnoea by delivering a
therapeutic breathing pressure to the PATIENT
Note 1 to entry: SLEEP APNOEA BREATHING THERAPY EQUIPMENT is primarily used in the HOME HEALTHCARE ENVIRONMENT by a
LAY OPERATOR without direct professional supervision.
201.4 General requirements
IEC 60601-1:2005+A1:2012, Clause 4 applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
IEC 60601-1:2005+A1:2012, 4.3 applies, except as follows:
Additional subclause:
201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE
For the purposes of this standard, SLEEP APNOEA BREATHING THERAPY EQUIPMENT is considered to not have
ESSENTIAL PERFORMANCE. Notwithstanding this fact, when this standard refers to ESSENTIAL PERFORMANCE as
acceptance criteria, the static pressure shall be evaluated. The method of subclause 202.6.2.1.10 may be
used to evaluate static pressure as an acceptance criterion following specific tests required by this standard.
201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Amendment (add at end of 4.6 prior to the compliance check):
The BREATHING GAS PATHWAY, its parts and ACCESSORIES shall be subject to the requirements for APPLIED
PARTS according to subclause 201.11.6.4. The SLEEP APNOEA BREATHING THERAPY EQUIPMENT parts or
ACCESSORIES that can come into contact with the PATIENT shall be subject to the requirements for APPLIED
PARTS according to this subclause.
NOTE The ACCESSORIES that can come into contact with the PATIENT also are subject to ISO 17510:—.
201.5 General requirements for testing of ME EQUIPMENT
IEC 60601-1:2005+A1:2012, Clause 5 applies, except as follows:
6 © ISO 2015 – All rights reserved

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
Addition:
201.5.101 Additional requirements for general requirements for testing of
ME EQUIPMENT
201.5.101.1 Gas flowrate and pressure specifications
In this standard, requirements for the flowrate and pressure are expressed as if tested under STPD (standard
temperature and pressure dry) conditions.
NOTE For the purposes of this standard, STPD is 101,3 kPa at an operating temperature of 20 °C, dry.
Correct all test measurements to STPD, as appropriate.
201.5.101.2 * SLEEP APNOEA BREATHING THERAPY EQUIPMENT testing errors
For the purposes of this standard, tolerances declared in the ACCOMPANYING DOCUMENTS shall include the
uncertainty of the measurement used to determine the specification.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005+A1:2012, Clause 6 applies.
201.7 ME EQUIPMENT identification, marking and documents
IEC 60601-1:2005+A1:2012, Clause 7 applies, except as follows:
201.7.1.2 * Legibility of markings
IEC 60601-1:2005+A1:2012, 7.1.2 applies, except as follows:
Replacement (at the end of the second sentence of the second paragraph of the compliance check):
Replace ‘1 m’ with ‘0,5 m’
Additional subclauses:
201.7.2.4.101 Additional requirements for ACCESSORIES
ACCESSORIES supplied separately shall fulfil the requirements of 201.7.2.101 and shall be marked with an
indication of any limitations or adverse effects of the ACCESSORY on the BASIC SAFETY of the SLEEP APNOEA
BREATHING THERAPY EQUIPMENT, if applicable. If marking the ACCESSORY is not practicable, this information may
be placed in the instructions for use.
Check compliance by inspection and inspection of the RISK MANAGEMENT FILE for any limitations or adverse
effects of the ACCESSORY.
201.7.2.13.101 Additional requirements for physiological effects
All natural rubber latex-containing components in the BREATHING GAS PATHWAYS or ACCESSORIES shall be
marked as containing latex. Such marking shall be CLEARLY LEGIBLE. Symbol 5.4.5 from ISO 15223-1:2012,
(Table 201.D.1.101, symbol 4) may be used. The instructions for use shall disclose all natural rubber latex-
containing components.
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
Check compliance by inspection.
201.7.2.17.101 Additional requirements for protective packaging
Packages shall be CLEARLY LEGIBLE and shall be marked as follows:
 with a description of the contents;
 with an identification reference to the batch, type or serial number or one of symbol 5.1.5, symbol 5.1.6 or
symbol 5.1.7 from ISO 15223-1:2012 (Table 201.D.1.101, symbol 1, symbol 2 or symbol 3 );
 with, for packages containing natural rubber latex, the word "LATEX", or symbol 5.4.5 from
ISO 15223-1:2012 (Table 201.D.1.101, symbol 4).
Check compliance by inspection.
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
The marking of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, parts or ACCESSORIES shall be CLEARLY LEGIBLE
and shall include the following:
a) any particular storage and/or handling instructions;
b) any particular warnings and/or precautions relevant to the immediate operation of the SLEEP APNOEA
BREATHING THERAPY EQUIPMENT;
If applicable, the marking of OPERATOR-accessible SLEEP APNOEA BREATHING THERAPY EQUIPMENT, parts or
ACCESSORIES shall be CLEARLY LEGIBLE and shall include the following, unless the size of ME EQUIPMENT, parts
or ACCESSORY, or the nature of its ENCLOSURE, does not allow affixation of these markings in which case the
remaining markings shall be recorded in the instructions for use,
c) an arrow indicating
...