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YY 9706.274-2022: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
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 BREATHIN...