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Position: Chinese Standard in English/GB 38598-2020
GB 38598-2020   General requirement for label and instruction book of disinfection products (English Version)
Standard No.: GB 38598-2020 Status:superseded remind me the status change

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Language:English File Format:PDF
Word Count: 10500 words Price(USD):300.0 remind me the price change

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Implemented on:2021-12-1 Delivery: via email in 1 business day
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Standard No.: GB 38598-2020
English Name: General requirement for label and instruction book of disinfection products
Chinese Name: 消毒产品标签说明书通用要求
Chinese Classification: C50    Sanitation in general
Professional Classification: GB    National Standard
Issued by: SAMR; SAC
Issued on: 2020-11-17
Implemented on: 2021-12-1
Status: superseded
Superseded by:GB 38598-2020/XG1-2024 General requirement for label and instruction book of disinfection products
Superseded on:2025-5-1
Language: English
File Format: PDF
Word Count: 10500 words
Price(USD): 300.0
Delivery: via email in 1 business day
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
Referred in GB 38598-2020:
*GB 190-2009 Packing symbol of dangerous goods
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB 15979-2002 Hygienic Standard for Disposable Sanitary Products
*GB/T 95-2002 Plain washers - Product grade C
*GB/T 2664-2009 Mens suits and coats
*GB 4706.1-2005 Household and Similar Electrical Appliances – Safety - Part 1: General Requirements
*GB 17625.1-2022 Electromagnetic compatibility—Limits—Part 1: Limits for harmonic current emissions (equipment input current ≤ 16A per phase)
*GB/T 14048.5-2017 Low-voltage switchgear and controlgear-Part 5-1:Control circuit devices and switching element-Electromechanical control circuit devices
*GB 17625.1-2022 Electromagnetic compatibility—Limits—Part 1: Limits for harmonic current emissions (equipment input current ≤ 16A per phase)
*QB/T 1333-2018 Handbag and Knapsack
*GB 2762-2022 National Food Safety Standard - Maximum Levels of Contaminants in Foods
*GB/T 22849-2014 Knitted T-shirt
*GB 5749-2022 Standards for drinking water quality
*GB 14748-2006 Safety Requirements for Wheeled Child Conveyances
*GB/T 1591-2018 High strength low alloy structural steels
*GB 4943.1-2011 Information technology equipment -Safety - Part 1: General requirements
*GB 2763-2021 National Food Safety Standard-Maximum Residue Limits for Pesticides in Food
GB 38598-2020 is referred in:
*GB 38456-2020 Hygienic requirements for antibacterial and bacteriostatic lotion
*GB/T 20808-2022 Paper towel
*DB13/T 1481-2011
*GB 5599-1985 Railway vehicles; Specification for evaluation the dynamic performance and accreditation test
*DB62/T 2239-2012
*DB11/Z 370-2006
*DB12/ 356-2008
*DB50/ 418-2012
*DB14/T 534-2009
*DB14/T 533-2009
*DB14/T 575-2010
*DB32/T 1553-2009
*GB 6011-1985 Test method for flammability characteristics of fiber-reinforced plastics; Incandescent rod method
*GB/T 5142-1985 Reach and straddle fork lift trucks; Stability tests
*GB/T 3452.3-1988 Fluid power systems-O-Ring-Design criteria for O-Ring housing-Basic calculation
*GB 50389-2006 Code for construction and acceptance of 750kV overhead transmission line
*YY/T 1240-2014 D-Dimer reagent (kit)
Code of China
Standard
GB 38598-2020  General requirement for label and instruction book of disinfection products (English Version)
Standard No.GB 38598-2020
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count10500 words
Price(USD)300.0
Implemented on2021-12-1
Deliveryvia email in 1 business day
Detail of GB 38598-2020
Standard No.
GB 38598-2020
English Name
General requirement for label and instruction book of disinfection products
Chinese Name
消毒产品标签说明书通用要求
Chinese Classification
C50
Professional Classification
GB
ICS Classification
Issued by
SAMR; SAC
Issued on
2020-11-17
Implemented on
2021-12-1
Status
superseded
Superseded by
GB 38598-2020/XG1-2024 General requirement for label and instruction book of disinfection products
Superseded on
2025-5-1
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
10500 words
Price(USD)
300.0
Keywords
GB 38598-2020, GB/T 38598-2020, GBT 38598-2020, GB38598-2020, GB 38598, GB38598, GB/T38598-2020, GB/T 38598, GB/T38598, GBT38598-2020, GBT 38598, GBT38598
Introduction of GB 38598-2020
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
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Keywords:
GB 38598-2020, GB/T 38598-2020, GBT 38598-2020, GB38598-2020, GB 38598, GB38598, GB/T38598-2020, GB/T 38598, GB/T38598, GBT38598-2020, GBT 38598, GBT38598