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
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
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
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
