Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the China National Light Industry Council.
This standard is issued for the first time.
Air cleaner for medical environment
1 Scope
This standard specifies the terms and definitions, specification and designation, requirements, test methods, inspection rules, marking, packaging, transportation and storage of air cleaners for medical environment.
It is applicable to indoor air cleaners for medical environment and environments with similar cleaning requirements, including:
——cleaners for medical indoor environment, including hospitals, sanatoriums, convalescent hospitals, blood stations and precision instrument rooms;
——cleaners for laboratories, nursing homes, kindergartens, health centers, residential buildings and the like with similar cleaning requirements;
——fresh air ventilators with similar cleaning function can be implemented by reference to this standard.
This standard is not applicable to:
——cleaners for hospital clean operating department and specially designed for industrial use;
——cleaners for the special environment and locations of corrosive and explosive gas (such as dust, vapor and gas).
Note: See Annex A for Classes II and III hospital environment.
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 191-2008 Packaging - Pictorial marking for handling of goods
GB/T 4214.1-2000 Acoustics - Household and similar electrical appliances - Test code for determination of airborne acoustical noise - Part 1: General requirements
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements
GB/T 5080.7-1986 Equipment reliability testing - Compliance test plans for failure rate and mean time between failures assuming constant failure rate
GB 9671-1996 Hygienic standard for hospital waiting room
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
GB/T 14295-2008 Air filters
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB 15982-2012 Hygienic standard for disinfection in hospitals
GB/T 18202-2000 Hygienic standard for ozone in indoor air
GB/T 18204.3-2013 Examination methods for public places - Part 3: Airborne microorganism
GB/T 18268.1-2010 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
GB/T 18801-2016 Air cleaner
JG/T 294-2010 Test of pollutant cleaning performance of air cleaner
WS/T 368-2012 Management specification of air cleaning technique in hospitals
The Ministry of Health Technical standard for disinfection (Edition 2002)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air cleaner for medical environment
an appliance that has effective removal capability for microorganism, particulate matter and gaseous pollutant in the air and can meet the requirements for medical treatment and similar purposes (hereinafter referred to as "appliance")
3.2
disinfection factor
an independent unit used in appliance that can kill natural bacteria in the air and reaches disinfection requirements
3.3
target pollutant
specific air pollutant with definite composition
Note: It is mainly divided into three categories: particulate matter, gaseous pollutant and microorganism.
3.4
natural decay
the reduction of concentration of the target pollutant in the air under specified space and conditions due to non-human factors such as settlement, agglomeration, surface deposition, chemical reaction and air exchange
3.5
total decay
the reduction of concentration of the target pollutant in the air under specified space and conditions due to combined action of natural decay and cleaning operation of the appliance
3.6
cleaning efficiency
ability of the appliance to remove a certain target pollutant before and after starting up for operation
3.7
one pass cleaning efficiency
ratio of the difference between the target pollutant concentration before and after passing through the appliance at one time and the target pollutant concentration before passing through under the rated air volume
Note: The value is expressed in %.
3.8
nominal airflow rate
the maximum airflow rate at outlet when the appliance is used at rated frequency and rated voltage
Note: The value is expressed in m3/h.
3.9
bacterium killing rate
ratio of the difference between the bacteria content in the air before the appliance is disinfected (except for naturally extinct bacteria) and the bacteria content in the air at different times during disinfection to the bacteria content in the air before disinfection
Note 1: The value is expressed in %.
Note 2: Staphylococcus albus is the representative strain in the test.
3.10
natural bacteria extinction rate
ratio of the difference between the mean number of natural bacteria in the air before disinfection and that after disinfection to the mean number of natural bacteria in the air before disinfection
Note: The value is expressed in %.
3.11
clean air delivery rate; CADR
product of one pass cleaning efficiency and nominal airflow rate
Note: For the convenience of determination, the clean air delivery rate of air cleaner with nominal airflow rate less than 700m3/h may be obtained in accordance with the decay method specified in GB/T 18801-2015.
4 Specification and designation
4.1 Specification
The nominal airflow rate is taken as the rule of designation and basic parameter for the appliance.
Note: The value is expressed in m3/h.
4.2 Designation of product model
Example: YKJ-A011600B
where: YKJ——the medical air cleaner;
A01——item 1 of series A;
1600——the nominal airflow rate is 1 600m3/h;
B——the second improved design.
5 Requirements
5.1 Appearance
5.1.1 The cleaner shall be upright in shape, clean and smooth in surface, uniform in color and luster, and free from defects such as blisters, cracks, rust and sharp edges as well as obvious scratches and bumps on the surface.
5.1.2 The words, symbols and graphic signs explaining functions on the outer surface shall be marked clearly, accurately and firmly.
5.1.3 Each control device shall be flexible, reliable and free from blockage. Fasteners shall be installed firmly without looseness.
5.2 Nominal airflow rate
The measured nominal airflow rate of the appliance shall not be less than 90% of the nominal value.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Specification and designation 5 Requirements 6 Test methods 7 Inspection rules 8 Marking, packaging, transportation and storage Annex A (Informative) Requirements of Classes II and III hospital environment Annex B (Normative) Test method for nominal airflow rate Annex C (Normative) Test method for cleaning performance Annex D (Normative) Identification test of air disinfection effect Annex E (Normative) Test method for use of ultraviolet lamps
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the China National Light Industry Council.
This standard is issued for the first time.
Air cleaner for medical environment
1 Scope
This standard specifies the terms and definitions, specification and designation, requirements, test methods, inspection rules, marking, packaging, transportation and storage of air cleaners for medical environment.
It is applicable to indoor air cleaners for medical environment and environments with similar cleaning requirements, including:
——cleaners for medical indoor environment, including hospitals, sanatoriums, convalescent hospitals, blood stations and precision instrument rooms;
——cleaners for laboratories, nursing homes, kindergartens, health centers, residential buildings and the like with similar cleaning requirements;
——fresh air ventilators with similar cleaning function can be implemented by reference to this standard.
This standard is not applicable to:
——cleaners for hospital clean operating department and specially designed for industrial use;
——cleaners for the special environment and locations of corrosive and explosive gas (such as dust, vapor and gas).
Note: See Annex A for Classes II and III hospital environment.
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 191-2008 Packaging - Pictorial marking for handling of goods
GB/T 4214.1-2000 Acoustics - Household and similar electrical appliances - Test code for determination of airborne acoustical noise - Part 1: General requirements
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements
GB/T 5080.7-1986 Equipment reliability testing - Compliance test plans for failure rate and mean time between failures assuming constant failure rate
GB 9671-1996 Hygienic standard for hospital waiting room
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
GB/T 14295-2008 Air filters
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB 15982-2012 Hygienic standard for disinfection in hospitals
GB/T 18202-2000 Hygienic standard for ozone in indoor air
GB/T 18204.3-2013 Examination methods for public places - Part 3: Airborne microorganism
GB/T 18268.1-2010 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
GB/T 18801-2016 Air cleaner
JG/T 294-2010 Test of pollutant cleaning performance of air cleaner
WS/T 368-2012 Management specification of air cleaning technique in hospitals
The Ministry of Health Technical standard for disinfection (Edition 2002)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air cleaner for medical environment
an appliance that has effective removal capability for microorganism, particulate matter and gaseous pollutant in the air and can meet the requirements for medical treatment and similar purposes (hereinafter referred to as "appliance")
3.2
disinfection factor
an independent unit used in appliance that can kill natural bacteria in the air and reaches disinfection requirements
3.3
target pollutant
specific air pollutant with definite composition
Note: It is mainly divided into three categories: particulate matter, gaseous pollutant and microorganism.
3.4
natural decay
the reduction of concentration of the target pollutant in the air under specified space and conditions due to non-human factors such as settlement, agglomeration, surface deposition, chemical reaction and air exchange
3.5
total decay
the reduction of concentration of the target pollutant in the air under specified space and conditions due to combined action of natural decay and cleaning operation of the appliance
3.6
cleaning efficiency
ability of the appliance to remove a certain target pollutant before and after starting up for operation
3.7
one pass cleaning efficiency
ratio of the difference between the target pollutant concentration before and after passing through the appliance at one time and the target pollutant concentration before passing through under the rated air volume
Note: The value is expressed in %.
3.8
nominal airflow rate
the maximum airflow rate at outlet when the appliance is used at rated frequency and rated voltage
Note: The value is expressed in m3/h.
3.9
bacterium killing rate
ratio of the difference between the bacteria content in the air before the appliance is disinfected (except for naturally extinct bacteria) and the bacteria content in the air at different times during disinfection to the bacteria content in the air before disinfection
Note 1: The value is expressed in %.
Note 2: Staphylococcus albus is the representative strain in the test.
3.10
natural bacteria extinction rate
ratio of the difference between the mean number of natural bacteria in the air before disinfection and that after disinfection to the mean number of natural bacteria in the air before disinfection
Note: The value is expressed in %.
3.11
clean air delivery rate; CADR
product of one pass cleaning efficiency and nominal airflow rate
Note: For the convenience of determination, the clean air delivery rate of air cleaner with nominal airflow rate less than 700m3/h may be obtained in accordance with the decay method specified in GB/T 18801-2015.
4 Specification and designation
4.1 Specification
The nominal airflow rate is taken as the rule of designation and basic parameter for the appliance.
Note: The value is expressed in m3/h.
4.2 Designation of product model
Example: YKJ-A011600B
where: YKJ——the medical air cleaner;
A01——item 1 of series A;
1600——the nominal airflow rate is 1 600m3/h;
B——the second improved design.
5 Requirements
5.1 Appearance
5.1.1 The cleaner shall be upright in shape, clean and smooth in surface, uniform in color and luster, and free from defects such as blisters, cracks, rust and sharp edges as well as obvious scratches and bumps on the surface.
5.1.2 The words, symbols and graphic signs explaining functions on the outer surface shall be marked clearly, accurately and firmly.
5.1.3 Each control device shall be flexible, reliable and free from blockage. Fasteners shall be installed firmly without looseness.
5.2 Nominal airflow rate
The measured nominal airflow rate of the appliance shall not be less than 90% of the nominal value.
Contents of QB/T 5217-2018
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Specification and designation
5 Requirements
6 Test methods
7 Inspection rules
8 Marking, packaging, transportation and storage
Annex A (Informative) Requirements of Classes II and III hospital environment
Annex B (Normative) Test method for nominal airflow rate
Annex C (Normative) Test method for cleaning performance
Annex D (Normative) Identification test of air disinfection effect
Annex E (Normative) Test method for use of ultraviolet lamps
