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 developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
General requirement for label and instruction book of disinfection products
1 Scope
This standard specifies the general requirements for label and instruction book of disinfectants, disinfection apparatus, indicators and sanitary products, and the marking requirements of various indexes.
It is applicable to disinfection products produced, sold and used within the territory of People's Republic of China.
It is not applicable to export disinfection products that are not sold and used in China.
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 190 Packing symbol of dangerous goods
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 15979 Hygienic standard for disposable sanitary products
Technical specification for disinfection (2002 Edition) (the Ministry of Health of the People's Republic of China
Regulations on designation of health-related products [(WEIFAJIANFA [2001] No.109)]
Measures for the metrological supervision and administration of quantitatively packed commodities ([2005] No.75 Decree of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China)
Catalogue of hazardous chemicals (Announcement of the 10th Department of the State Administration of Work Safety No.5, 2015)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
disinfection products
products related to human health, such as disinfectants, disinfection apparatus, indicators and sanitary products, which are included in the catalogue of production categories of disinfection products
Note 1: The indicators include biological indicators, chemical indicators and sterilization packaging materials.
Note 2: The sanitary products include antibacterial agents, bacteriostats, contact lens care products (including contact lens care solution, contact lens preservation solution and contact lens cleaner), wet wipes, hygiene wet wipes and other sanitary products.
3.2
new disinfection products
disinfectant and disinfection apparatus produced by new materials, new technology and new principle of sterilization
3.3
disinfectant
preparation used to kill microorganisms on a transmission medium to achieve disinfection or sterilization requirements
3.4
disinfection apparatus
device or equipment (except indicator) used to kill microorganisms on a transmission medium to achieve disinfection or sterilization requirements
Note: The indicators include biological indicators, chemical indicators and sterilization packaging materials.
3.5
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
3.6
chemical indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process
3.7
sterilization packaging material
final sterilized medical apparatus packaging material with sterilization label
3.8
antibacterial agent
preparation that directly contacts with the intact skin or mucosa of human body and has certain bactericidal effect
3.9
bacteriostat
preparation that directly contacts with the intact skin or mucosa of human body and has certain bacteriostatic effect
3.10
wet wipe
products prepared by adding appropriate amount of production water, preservatives and other auxiliary elements on the carriers such as non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp papers to have cleaning functions to the treated objects (such as hands, skin, mucosa and ordinary object surfaces).
3.11
hygiene wet wipe
wet wipes prepared by adding appropriate amount of production water and disinfectant on the carriers such as non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp papers to have cleaning and sterilizing functions to the treated objects (such as hands, skin, mucosa and ordinary object surfaces)
3.12
other sanitary product
all kinds of daily products that are discarded immediately after use, come into direct contact with human body, and are used for the purpose of human physiological hygiene or hygiene and health (antibacterial or bacteriostatic).
Note: It includes sanitary napkins, sanitary pads, sanitary plug (built-in tampons), diapers, napkins (pads and paper), snoopy, paper towels (paper), sanitary napkins (sticks, labels and balls), cotton pads (paper and towels), hand (finger) covers, paper tableware, etc. Paper towels (paper) include facial tissue, napkin tissue, handkerchief paper, paper towel, bathroom tissue (except toilet paper), etc.
3.13
disinfection sanitary product
sanitary products treated by ethylene oxide, ionizing radiation, pressure steam or other effective disinfection methods and meeting the disinfection requirements specified in GB 15979
3.14
minimum sales packaging
packaging of minimum sales units that are sold for the purpose of marketing and delivered to the consumers together with the internal packaged disinfection products by manufacturers
3.15
label
carrier of characters, numbers, symbols, patterns and other instructions pasted, connected or printed on the packaging of disinfection products
3.16
nameplate
signs of information such as identification, remember and application guide that are fixed or pasted on disinfection apparatus with disinfection or sterilization functions, and need to provide to the users
Note: It includes characters, numbers, symbols, patterns and other descriptions, which are used to record the relevant technical parameters of manufacturers and products under rated working conditions.
3.17
instruction book
detailed introduction for product performance, application range, application method and precautions of a certain product by characters, numbers, symbols, patterns and forms, etc.
3.18
display surface
any surface of disinfection products (except the bottom surface) that can be seen by consumers during display
3.19
visible surface
any surface of well-packaged disinfection products that can be seen by consumers
3.20
net mass
mass, volume, length, area, counting and marking of the internal disinfection products after removing the packaging container and other packaging materials
3.21
product specification
description of specific traits of disinfection products that may be expressed in terms of weight, quantity and size (including length, width or height)
3.22
package specification
quantity of transported and packaged products
3.23
valid period
period during which the product stability of disinfection products can meet the specified requirements at specified storage conditions
3.24
shelf life
period for maintaining the quality of disinfection products under the conditions specified by disinfection product standards and labels
Note: During this period, disinfection products shall meet the quality specified in product standards and labels.
3.25
machine service life
working time from normal use to functional loss of disinfection apparatus
Note: In years.
3.26
main component service life
cumulative working time of main components of disinfection apparatus from normal use to reduction of main sterilization factors or main technical parameters to the lower limit of rated value
Note: In hours, months and years.
3.27
responsibility unit
legal unit that are liable for compensation for personal injury or property losses caused by product defects in accordance with the law
Note: During entrusting production, the responsible unit refers specifically to the entrusting party; during production of a branch (subsidiary) company without independent legal person qualification under the same group or a branch plant or workshop without independent legal person qualification under the same production enterprise, the responsible unit specifically refers to the group and production enterprise.
3.28
responsibility unit in China
only responsibility unit that imported products are legally registered within the territory of China
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for disinfectant
5 Requirements for disinfecting apparatus
6 Requirements for indicators
7 Requirements for sanitary products
8 Labeling requirements for each index
Annex A (Informative) Writing examples of labels and instruction book of disinfection products
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 developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
General requirement for label and instruction book of disinfection products
1 Scope
This standard specifies the general requirements for label and instruction book of disinfectants, disinfection apparatus, indicators and sanitary products, and the marking requirements of various indexes.
It is applicable to disinfection products produced, sold and used within the territory of People's Republic of China.
It is not applicable to export disinfection products that are not sold and used in China.
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 190 Packing symbol of dangerous goods
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 15979 Hygienic standard for disposable sanitary products
Technical specification for disinfection (2002 Edition) (the Ministry of Health of the People's Republic of China
Regulations on designation of health-related products [(WEIFAJIANFA [2001] No.109)]
Measures for the metrological supervision and administration of quantitatively packed commodities ([2005] No.75 Decree of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China)
Catalogue of hazardous chemicals (Announcement of the 10th Department of the State Administration of Work Safety No.5, 2015)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
disinfection products
products related to human health, such as disinfectants, disinfection apparatus, indicators and sanitary products, which are included in the catalogue of production categories of disinfection products
Note 1: The indicators include biological indicators, chemical indicators and sterilization packaging materials.
Note 2: The sanitary products include antibacterial agents, bacteriostats, contact lens care products (including contact lens care solution, contact lens preservation solution and contact lens cleaner), wet wipes, hygiene wet wipes and other sanitary products.
3.2
new disinfection products
disinfectant and disinfection apparatus produced by new materials, new technology and new principle of sterilization
3.3
disinfectant
preparation used to kill microorganisms on a transmission medium to achieve disinfection or sterilization requirements
3.4
disinfection apparatus
device or equipment (except indicator) used to kill microorganisms on a transmission medium to achieve disinfection or sterilization requirements
Note: The indicators include biological indicators, chemical indicators and sterilization packaging materials.
3.5
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
3.6
chemical indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process
3.7
sterilization packaging material
final sterilized medical apparatus packaging material with sterilization label
3.8
antibacterial agent
preparation that directly contacts with the intact skin or mucosa of human body and has certain bactericidal effect
3.9
bacteriostat
preparation that directly contacts with the intact skin or mucosa of human body and has certain bacteriostatic effect
3.10
wet wipe
products prepared by adding appropriate amount of production water, preservatives and other auxiliary elements on the carriers such as non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp papers to have cleaning functions to the treated objects (such as hands, skin, mucosa and ordinary object surfaces).
3.11
hygiene wet wipe
wet wipes prepared by adding appropriate amount of production water and disinfectant on the carriers such as non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp papers to have cleaning and sterilizing functions to the treated objects (such as hands, skin, mucosa and ordinary object surfaces)
3.12
other sanitary product
all kinds of daily products that are discarded immediately after use, come into direct contact with human body, and are used for the purpose of human physiological hygiene or hygiene and health (antibacterial or bacteriostatic).
Note: It includes sanitary napkins, sanitary pads, sanitary plug (built-in tampons), diapers, napkins (pads and paper), snoopy, paper towels (paper), sanitary napkins (sticks, labels and balls), cotton pads (paper and towels), hand (finger) covers, paper tableware, etc. Paper towels (paper) include facial tissue, napkin tissue, handkerchief paper, paper towel, bathroom tissue (except toilet paper), etc.
3.13
disinfection sanitary product
sanitary products treated by ethylene oxide, ionizing radiation, pressure steam or other effective disinfection methods and meeting the disinfection requirements specified in GB 15979
3.14
minimum sales packaging
packaging of minimum sales units that are sold for the purpose of marketing and delivered to the consumers together with the internal packaged disinfection products by manufacturers
3.15
label
carrier of characters, numbers, symbols, patterns and other instructions pasted, connected or printed on the packaging of disinfection products
3.16
nameplate
signs of information such as identification, remember and application guide that are fixed or pasted on disinfection apparatus with disinfection or sterilization functions, and need to provide to the users
Note: It includes characters, numbers, symbols, patterns and other descriptions, which are used to record the relevant technical parameters of manufacturers and products under rated working conditions.
3.17
instruction book
detailed introduction for product performance, application range, application method and precautions of a certain product by characters, numbers, symbols, patterns and forms, etc.
3.18
display surface
any surface of disinfection products (except the bottom surface) that can be seen by consumers during display
3.19
visible surface
any surface of well-packaged disinfection products that can be seen by consumers
3.20
net mass
mass, volume, length, area, counting and marking of the internal disinfection products after removing the packaging container and other packaging materials
3.21
product specification
description of specific traits of disinfection products that may be expressed in terms of weight, quantity and size (including length, width or height)
3.22
package specification
quantity of transported and packaged products
3.23
valid period
period during which the product stability of disinfection products can meet the specified requirements at specified storage conditions
3.24
shelf life
period for maintaining the quality of disinfection products under the conditions specified by disinfection product standards and labels
Note: During this period, disinfection products shall meet the quality specified in product standards and labels.
3.25
machine service life
working time from normal use to functional loss of disinfection apparatus
Note: In years.
3.26
main component service life
cumulative working time of main components of disinfection apparatus from normal use to reduction of main sterilization factors or main technical parameters to the lower limit of rated value
Note: In hours, months and years.
3.27
responsibility unit
legal unit that are liable for compensation for personal injury or property losses caused by product defects in accordance with the law
Note: During entrusting production, the responsible unit refers specifically to the entrusting party; during production of a branch (subsidiary) company without independent legal person qualification under the same group or a branch plant or workshop without independent legal person qualification under the same production enterprise, the responsible unit specifically refers to the group and production enterprise.
3.28
responsibility unit in China
only responsibility unit that imported products are legally registered within the territory of China
Contents of GB 38598-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for disinfectant
5 Requirements for disinfecting apparatus
6 Requirements for indicators
7 Requirements for sanitary products
8 Labeling requirements for each index
Annex A (Informative) Writing examples of labels and instruction book of disinfection products
