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YY 1881-2023: Powered air-purifying respirator (PAPR) used in healthcare settings
YY 1881-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
CCS C 47
Powered air-purifying respirator (PAPR) used in healthcare
settings
ISSUED ON: JUNE 20, 2023
IMPLEMENTED ON: JULY 01, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Classification and tags ... 9
5 Requirements ... 10
5.1 Basic requirements ... 10
5.2 Primary skin irritation ... 10
5.3 Filter element ... 10
5.3.1 Basic requirements ... 10
5.3.2 Mechanical strength ... 11
5.3.3 Filtration efficiency ... 11
5.4 Minimum flow rate ... 11
5.5 Continuous use time ... 11
5.6 Anti-crushing of air supply tube ... 11
5.7 Prompt function ... 12
5.7.1 Prompt for low flow rate ... 12
5.7.2 Prompt for low battery ... 12
5.8 Total inward leakage ... 13
5.9 Respiratory resistance ... 13
5.10 Dead space ... 13
5.11 Noise ... 13
5.12 Mass ... 13
5.13 Call performance ... 13
5.14 Flame retardant (if applicable) ... 14
5.15 Window ... 14
5.15.1 Field of view ... 14
5.15.2 Transmittance and haze ... 14
5.15.3 Window mechanical strength ... 14
5.16 Material breaking strength ... 14
5.17 Connection strength ... 14
5.18 Exhaust valve (if applicable) ... 15
5.18.1 Exhaust valve tightness ... 15
5.18.2 Exhaust valve connection strength ... 15
5.19 Resistance to synthetic blood penetration ... 15
5.20 Microbiological indicators ... 15
5.21 Ethylene oxide residue (if applicable) ... 16
5.22 Reusable hood (mask) (if applicable) ... 16
5.23 Environment test ... 16
5.24 Electrical safety and electromagnetic compatibility ... 16
6 Test methods ... 16
6.1 Test conditions ... 16
6.2 Basic requirements ... 16
6.3 Primary skin irritation ... 16
6.4 Head mode ... 17
6.5 Environment test ... 17
6.6 Pretreatment conditions ... 18
6.7 Filter elements ... 19
6.7.1 Basic requirements ... 19
6.7.2 Mechanical strength ... 19
6.7.3 Filtration efficiency ... 19
6.8 Flow rate ... 21
6.8.1 Sample quantity and requirements ... 21
6.8.2 Test equipment and conditions ... 21
6.8.3 Test methods ... 22
6.9 Continuous use time ... 23
6.10 Anti-crushing of air supply tube ... 23
6.11 Prompt ... 24
6.11.1 Prompt for low flow rate ... 24
6.11.2 Prompt for low battery ... 25
6.12 Total inward leakage ... 25
6.12.1 Sample preparation ... 25
6.12.2 Test methods ... 26
6.12.3 Result calculation ... 27
6.13 Respiratory resistance ... 28
6.14 Dead space ... 29
6.14.1 Sample quantity and requirements ... 29
6.14.2 Testing equipment ... 29
6.14.3 Test methods ... 30
6.15 Noise ... 31
6.16 Quality ... 31
6.17 Call performance ... 31
6.18 Flame retardant ... 31
6.19 Window ... 31
6.19.1 Field of view ... 31
6.19.2 Transmittance and haze ... 31
6.19.3 Window mechanical strength ... 31
6.20 Material breaking strength ... 32
6.21 Connection strength ... 32
6.22 Exhaust valve ... 32
6.22.1 Sample quantity and requirements ... 32
6.22.2 Exhaust valve sealing ... 32
6.22.3 Exhaust valve connection strength ... 32
Powered air-purifying respirator (PAPR) used in healthcare
settings
1 Scope
This document specifies the classification and tags, requirements, test methods, marks
and instructions for use, packaging and storage of powered air-purifying respirator used
in healthcare settings.
The document is applicable to powered air-purifying respiratory protection devices that
are working in medical working environment or other environment where the risk of
exposure to pathogenic microorganism aerosols is assessed, used to filter microbial
particles in the air and block pollutants such as droplets and blood.
This document does not apply to powered air-purifying respirator for protection against
toxic and hazardous gases. It is also not suitable for respirators for industrial dust,
combustion, explosion, oxygen-deficient environments and escape.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 2410-2008, Determination of the luminous transmittance and haze of
transparent plastics
GB 2626-2019, Respiratory protection -- Non-powered air-purifying particle
respirator
GB/T 3785.1-2010, Electroacoustics -- Sound level meters -- Part 1: Specifications
GB 9706.1, Medical electrical equipment -- Part 1: General requirements for basic
safety and essential performance
GB/T 12903-2008, Personal protective equipment terminology
GB/T 14233.1, Test methods for infusion, transfusion, injection equipment for
medical use -- Part 1: Chemical analysis methods
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
5 Requirements
5.1 Basic requirements
Product materials and structural design shall meet the following requirements:
a) The materials used in the product shall be able to ensure that when the product is
used in the expected environment, there will be no obvious deformation, cracking,
etc., and it is not easy to cause structural damage;
b) The tight-fitting hood shall be able to facilitate the wearer to check the air
tightness of the hood;
c) If there is an exhaust port design in front of the head (face) mask, the design shall
be able to prevent pollutants such as blood from spraying into the exhaust port,
and prevent droplets generated by the wearer from contaminating the patient's
wound;
d) The product shall be easy to put on and take off, and can be safely and firmly
fixed on the wearer without causing obvious pressure. There shall also be no sharp
protrusions that can cause harm to the wearer during the process of putting on and
taking off and using;
e) The air supply tube shall not restrict the wearer's head and body movements, nor
shall it restrict or block airflow during movement;
f) The product design shall prevent the flow rate from being accidentally changed by
the user;
g) The airflow shall be odorless. The airflow distribution shall ensure fresh airflow
across the wearer's face and shall not cause tension and discomfort to the wearer
(such as local overcooling or irritation to the eyes).
5.2 Primary skin irritation
For materials that come into direct contact with the head, face or neck, skin irritation
shall be evaluated in accordance with GB/T 16886.10. The primary skin irritation index
shall not be greater than 0.4.
5.3 Filter element
5.3.1 Basic requirements
The design shall meet the following requirements:
5.7 Prompt function
5.7.1 Prompt for low flow rate
The product shall have a low flow rate prompt function and meet the following
requirements.
a) When the flow rate is lower than the minimum flow rate required by 5.4.1, the
prompt device shall be able to be effectively activated within 30 s and continue
to prompt until the minimum flow rate requirement is met.
b) The user cannot close the prompt manually.
c) The prompt function cannot be invalidated due to the operation, settings, etc. of
other parts of the product.
d) The prompt method shall meet the following requirements:
1) The prompt is easily recognized by the user;
2) It shall be different from the low battery warning method, so that users can
identify the reason for the warning;
3) If only sound is used for prompting or other prompting methods cannot be
successfully recognized by the user, the sound prompt volume shall not be
lower than 80 dB(A).
5.7.2 Prompt for low battery
The product shall have a low battery prompt function and meet the following
requirements.
a) The low-battery prompt device can estimate the power usage based on the power
consumption. When the power is insufficient to maintain the minimum flow rate,
the first prompt will be activated at least 15 min in advance. The second prompt
will be activated at least 10 min in advance to remind the user to leave the
dangerous environment in time.
b) The user cannot manually close the second prompt.
c) The prompt function cannot be invalidated due to the operation, settings, etc. of
other parts of the product.
d) The prompt method shall meet the following requirements:
1) The prompt is easily recognized by the user;
5.14 Flame retardant (if applicable)
If the manufacturer claims that the product has flame retardant properties, all parts
exposed to the flame shall not burn or continue to burn for more than 5 s after the flame
is removed.
5.15 Window
5.15.1 Field of view
The field of view shall meet the following requirements:
a) The number of effective observation points of the perimeter shall be no less than
98;
b) In the four directions of the perimeter: 25°, 155°, 195° and 345°, at least 6 of the
8 observation points in the peripheral area of each direction shall be valid
observation points.
5.15.2 Transmittance and haze
The light transmittance of transparent materials shall be no less than 85% and the haze
shall be no more than 4%.
5.15.3 Window mechanical strength
Test according to 6.19.3. The window shall not show any damage.
5.16 Material breaking strength
The breaking strength of the hood (mask) material shall not be less than 45 N.
5.17 Connection strength
5.17.1 The joint strength between the hood (mask) and the window and surrounding
materials shall be no less than 30 N.
5.17.2 The connection between the air supply tube and the fan shall not slip, break or
deform when subjected to an axial tensile force of 250 N for 10 s. The connection
between the hood (mask) and the air supply tube shall not slip, break or deform when
subjected to an axial tensile force of 50 N for 10 s.
5.21 Ethylene oxide residue (if applicable)
If the hood or face mask is disinfected or sterilized with ethylene oxide, the residual
ethylene oxide shall not exceed 10 μg/g.
5.22 Reusable hood (mask) (if applicable)
If the hood (mask) is reusable, the window, material breaking strength, connection
strength, exhaust valve (if applicable) and resistance to synthetic blood penetration shall
be tested after the hood (mask) has been sterilized for the maximum number of times
according to the sterilization method claimed by the manufacturer. The results shall
meet the requirements of 5.15, 5.16, 5.17, 5.18 and 5.19 respectively.
5.23 Environment test
The powered flow rate system shall be subjected to environment test and comply with
the requirements of climate environment group II and mechanical environment group
II in GB/T 14710-2009.
5.24 Electrical safety and electromagnetic compatibility
5.24.1 Electrical safety shall comply with the requirements of GB 9706.1.
5.24.2 Electromagnetic compatibility shall comply with the requirements of YY
9706.102.
6 Test methods
6.1 Test conditions
Unless otherwise specified, the test shall be carried out in an environment with a
temperature of 16℃~32℃ and a relative humidity of (50±30)%.
6.2 Basic requirements
Evaluate the practical performance of the respirator according to the method in Annex
A. Check whether the results meet the requirements of 5.1.
6.3 Primary skin irritation
Cut the materials that may contact the skin from at least two sets of respirator samples.
6.7 Filter elements
6.7.1 Basic requirements
Take at least 2 powered flow rate systems. Replace the filter according to the
manufacturer's instructions. If the filter element is tightly fitted after installation and
there is no looseness, and there is no obvious deviation or visible gap at the joint, it is
considered to meet the requirements of 5.3.1 a). Replace the filter element in actual
operation and check the airflow direction mark of the filter element. Check whether it
meets the requirements of 5.3.1 b).
6.7.2 Mechanical strength
Take at least 4 filter elements and perform mechanical strength pretreatment on the filter
elements according to the method in 6.2.2 of GB 2626-2019.
6.7.3 Filtration efficiency
6.7.3.1 Sample quantity and requirements
Take at least 4 filter elements and carry out temperature and humidity pretreatment and
mechanical strength pretreatment according to 6.6 and 6.7.2 respectively.
6.7.3.2 Test system and conditions
The test environment temperature is (25±5)℃ and the relative humidity is (30±10)%.
The testing system (see Figure 1) shall meet the following parameter conditions.
a) Aerosol generating system:
1) Can produce dried and charged neutralized sodium chloride particles;
2) The aerosol concentration is not greater than 200 mg/m3. After stabilization,
the concentration change does not exceed ±10% during the entire test process;
3) Particle size distribution: The counting median diameter is (0.075±0.020) μm.
Geometric standard deviation of particle distribution ≤1.86.
NOTE: The counting median diameter (CMD) of 0.075 μm is equivalent to the mass median
aerodynamic diameter (MMAD) of about 0.3 μm.
b) The testing flow range is 15 L/min~170 L/min, with an accuracy of 2%.
c) The dynamic testing range of particulate matter is 0.001 mg/m3 ~200 mg/m3. The
accuracy is 0.001 mg/m3 or 1%.
Connect the equipment according to the method in 6.8 and test the flow rate. Then place
the air supply tube in the middle between the two discs. Apply a pressure of 50 N to the
air supply tube (including the weight of the upper disc). Test the flow rate again. Record
the flow rate values before and after the pressure is applied. Calculate whether the value
change meets the requirements of 5.6. After the pressure is removed for 5 min, observe
the deformation of the air supply tube.
If multiple air supply tubes are used simultaneously, a pressure of 50 N shall be applied
to each tube and tested simultaneously.
6.11 Prompt
6.11.1 Prompt for low flow rate
6.11.1.1 Pr...