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YY 9706.274-2022 PDF in English


YY 9706.274-2022 (YY9706.274-2022) PDF English
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YY 9706.274-2022: PDF in English

YY9706.274-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
YY 9706.274-2022
Replacing YY 0786-2010
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment
(ISO 80601-2-74:2017, MOD)
ISSUED ON: JANUARY 13, 2022
IMPLEMENTED ON: MAY 01, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
Introduction ... 8
201.1 Scope, object and related standards ... 10
201.2 Normative references ... 13
201.3 Terms and definitions ... 15
201.4 General requirements ... 19
201.5 General requirements for testing of ME EQUIPMENT ... 22
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 23
201.7 ME EQUIPMENT identification, marking and documents ... 24
201.8 Protection against electrical HAZARDS form ME EQUIPMENT ... 33
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS
... 33
201.10 Protection against unwanted and excessive radiation HAZARDS ... 35
201.11 Protection against excessive temperatures and other HAZARDS ... 35
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 39
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ... 43
201.14 Programmable electrical medical systems (PEMS) ... 44
201.15 Construction of ME EQUIPMENT ... 44
201.16 ME SYSTEMS ... 45
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ... 45
201.101 BREATHING SYSTEM connectors and ports ... 45
201.102 Requirements for the BREATHING SYSTEM and ACCESSORIES ... 48
201.103 LIQUID CONTAINER ... 49
201.104 FUNCTIONAL CONNECTION ... 50
202 Electromagnetic disturbances - Requirements and tests ... 50
206 Usability ... 51
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems ... 53
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment ... 53
Annex C (informative) Guide to marking and labelling requirements for ME
EQUIPMENT and ME SYSTEMS ... 55
Annex D (informative) Symbols on Marking ... 61
Annex AA (informative) Particular guidance and rationale ... 63
Annex BB (normative) * Determination of the accuracy of the displayed MEASURED
GAS TEMPERATURE ... 84
Annex CC (normative) Determination of the HUMIDIFICATION OUTPUT ... 86
Annex DD (normative) Specific enthalpy calculations ... 92
Annex EE (normative) Removable temperature sensors and mating ports ... 94
Annex FF (normative) * Standard temperature sensor ... 97
Annex GG (informative) Saturation vapour pressure ... 99
Annex HH (informative) Reference to the essential principles of safety and
performance of medical devices in accordance with ISO 16142-1:2016[7] ... 100
Bibliography ... 105
Foreword
All technical content of this Part is mandatory.
The “Medical electrical equipment” series of standards consist of two parts:
- Part 1: General and collateral requirements;
- Part 2: Particular requirements.
This Part is Part 2-74.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0786-2010 “Medical suction equipment - Part 3: Suction
equipment powered from a vacuum or pressure source”. Compared with YY 0786-2010,
the main technical changes, except for editorial modifications, are as follows:
- EXTEND the scope to include the HUMIDIFIER and its ACCESSORIES, where
the characteristics of those ACCESSORIES can affect the BASIC SAFETY and
ESSENTIAL PERFORMANCE of the HUMIDIFIER, and thus not only
requirements for the HUMIDIFIER itself (see 201.1.1 of this Part, Clause 1 of YY
0786-2010);
- ADD the ESSENTIAL PERFORMANCE of respiratory humidifying equipment
and its accessories (see 201.4.3);
- MODIFY the humidification test procedure and the disclosure of humidification
performance (see 201.12.1.101 and Annex CC of this Part, 101 and Annex EE of
YY 0786-2010);
- MODIFY the requirements for removable temperature sensor ports and sensor
marking (see 201.101.8 and Annex EE of this Part, 56.102 and Annex DD of YY
0786-2010);
- DELETE the requirements for “bubble” humidifiers (see Clause 1 of YY 0786-
2010), which will be given in a separate standard[8];
- ADD cleaning and disinfection PROCEDURES (see 201.7.9.2.12 and 201.11.6.6);
- ADD the test of protection provided by ENCLOSURE (see 201.11.6.6);
- ADD the requirements for BIOCOMPATIBILITY (see 201.11.7);
- ADD the requirements when a HUMIDIFIER is used as a component of the ME
SYSTEM (see 201.1.1 and 201.16.1.101);
- ADD the electromagnetic compatibility (see 202);
- ADD special requirements for respiratory humidifying equipment in the collateral
standard of usability (see 206);
- ADD special requirements for respiratory humidifying equipment in the collateral
standard of alarm systems (see 208);
- ADD special requirements for respiratory humidifying equipment in the collateral
standard of home healthcare environment (see 211);
- ADD the test of mechanical strength (see 211.10.1.1);
- ADD new symbols (see Annex D).c
This Part modified and adopted ISO 80601-2-74:2017 "Medical Electrical Equipment
Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory
Humidification Equipment" using the redrafting method.
The technical differences between this Part and ISO 80601-2-74:2017 and their reasons
are as follows:
- Regarding normative references, this Part has made adjustments with technical
differences to adapt to the technical conditions of China. The adjustments are
reflected in Clause 2 “Normative references”. The specific adjustments are as
follows:
● REPLACE IEC 61672-1:2013 with GB/T 3785.1, which is identical to the
international standard;
● REPLACE IEC 60601-1:2005 + AMD1:2012 with GB 9706.1-2020, which
modified and adopted the international standard;
● REPLACE IEC 60601-2-19:2009 with GB 9706.219-2021, which modified and
adopted the international standard;
● REPLACE ISO 14937:2009 with GB/T 19974, which modified and adopted the
international standard;
● REPLACE ISO 5356-1:2015 with YY/T 1040.1, which is identical to the
international standard;
● REPLACE IEC 60601-1-2:2014 with YY 9706.102-2021, which modified and
adopted the international standard;
● REPLACE ISO 9360-1:2000 with YY/T 0735.1, which is identical to the
international standard (see 201.1.1, 201.2, 201.3, 201.7.9.2.9.101.2);
● REPLACE ISO 9360-2:2001 with YY/T 0735.2, which is identical to the
international standard (see 201.1.1, 201.2, 201.3, 201.7.9.2.9.101.2);
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment
201.1 Scope, object and related standards
General standard, Clause 1 applies, except as follows.
201.1.1 * Scope
Replacement:
This Part 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.
This Part is also applicable to those ACCESSORIES intended by their
MANUFACTURER to be connected to a HUMIDIFIER where the characteristics of
those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL
PERFORMANCE of the HUMIDIFIER.
EXAMPLE 1: Heated BREATHING TUBES (heated-wire BREATHING TUBES) or ME
EQUIPMENT intended to control these heated BREATHING TUBES (heated BREATHING TUBE
controllers).
NOTE 1: Heated BREATHING TUBES and their controllers are ME EQUIPMENT and are subject
to the requirements of GB 9706.1.
NOTE 2: YY 0461 specifies other safety and performance requirements for BREATHING TUBES.
This Part includes requirements for the different medical uses of humidification, such
as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and
obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy
PATIENTS.
NOTE 3: A HUMIDIFIER can be integrated into other equipment. When this is the case, the
requirements of the other equipment also apply to the HUMIDIFIER.
EXAMPLE 2: Heated HUMIDIFIER incorporated into a critical care ventilator where GB
9706.212[12] also applies.
EXAMPLE 3: Heated HUMIDIFIER incorporated into a homecare ventilator for dependent
PATIENTS where ISO 80601-2-72[14] also applies.
of NORMAL USE and is moved over a threshold as described in GB 9706.1-
2020, 9.4.2.4.3.
f) Return the HUMIDIFIER to normal orientation and subsequently refill the
LIQUID CONTAINER to the maximum level then add a further quantity equal
to 15 % of the capacity of the LIQUID CONTAINER, poured in steadily over a
period of 1 min.
g) After these PROCEDURES, the HUMIDIFIER is to pass the appropriate
dielectric strength and LEAKAGE CURRENT tests and is to show no signs of
wetting of uninsulated electrical parts or electrical insulation of parts that could
result in the loss of BASIC SAFETY or ESSENTIAL PERFORMANCE in
NORMAL CONDITION or in combination with a SINGLE FAULT
CONDITION (based on a visual inspection).
h) In addition, confirm that there is no more liquid than is specified in 201.13.1.101
exits the HUMIDIFICATION CHAMBER outlet.
201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM
Amendment (add additional requirement as new first paragraph):
aa) GAS PATHWAYS through the HUMIDIFIER and its ACCESSORIES that can
become contaminated with body fluids or expired gases during NORMAL
CONDITION or SINGLE FAULT CONDITION that are not single use:
1) shall be designed to allow for cleaning and disinfection or cleaning and
sterilization (additional requirements are found in GB 9706.1-2020, 11.6.7
and YY 9706.111-2021, Clause 8).
2) Dismantling may be used.
Amendment (add additional requirement and replace the compliance test):
bb) HUMIDIFIER ENCLOSURES shall be designed to allow for surface cleaning
and disinfection to reduce to acceptable levels the RISK of cross infection of the
OPERATOR, other persons or next PATIENT.
cc) Instructions for processing and reprocessing the HUMIDIFIER and its
ACCESSORIES shall
100) comply with YY/T 0802 and GB/T 19974, and
101) be disclosed in the instructions for use.
NOTE 1: GB/T 19891 provides guidance for the design of ENCLOSURES.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.