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GB 38850-2020: List for materials and restricted substances in disinfectant
GB 38850-2020
List for materials and restricted substances in disinfectant
ICS 11.080
C50
National Standards of People's Republic of China
Disinfectant raw material list and prohibited substances
Released on 2020-04-09
2020-11-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Foreword
All technical contents of this standard are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Health Commission of the People's Republic of China.
This standard was drafted by. China Center for Disease Control and Prevention, Environmental and Health-related Product Safety Institute, National Health Commission
Supervision Center, Zhejiang Provincial Center for Disease Control and Prevention.
The main drafters of this standard. Li Xinwu, Ban Haiqun, Sun Shouhong, Hu Guoqing, Wang Yanyan, Shen Kaicheng, Lu Hui, Fei Yunbin, Wu Liang, Wang Yurong,
Sun Jiansheng, Ren Yinping, Sun Wen.
Disinfectant raw material list and prohibited substances
1 Scope
This standard specifies the list of ingredients and the scope of use of the disinfectant applied to different disinfection objects, and also specifies the disinfectant formula
Of prohibited and restricted substances.
This standard is applicable to disinfection of drinking water, human body, medical equipment, environment and surface of objects, pollutants, indoor air, centralized air conditioning and ventilation
Disinfectant for system, swimming pool water, hospital sewage.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB 5749 Sanitary Standards for Drinking Water
GB/T 19104 Peracetic acid solution
GB/T 19106 sodium hypochlorite
GB/T 20783 Stable chlorine dioxide solution
HG/T 3779 Sodium dichloroisocyanurate
Pharmacopoeia of the People's Republic of China (2015 edition)
Standards for sanitary safety evaluation of sanitary disinfectants and disinfection equipment for drinking water [Ministry of Health (Wei Jianfa [2005] No. 336)]
Cosmetics Safety Technical Specifications (2015 Edition) (State Administration of Food and Drug Administration)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Disinfectant
A preparation used to kill pathogenic microorganisms on a transmission medium to achieve disinfection or sterilization requirements.
Note. The disinfectant specified in this standard includes not only preparations made up of chemical ingredients, biological ingredients and metal ions, but also special generators or generators.
Sodium hypochlorite, ozone gas, ozone water, acidic oxidation potential water, slightly acidic electrolyzed water and chlorine dioxide.
3.2
Active (active) activeingredient
In disinfectant formulations, substances that have a killing effect on pathogenic microorganisms.
3.3
Inertingredient
In the formulation of disinfectant, it has the auxiliary functions of anti-corrosion, skin care, stability, pH adjustment, flavoring and coloring.
3.4
Biologically active (active) ingredient
In the formulation of disinfectants, the extracts of organisms or microorganisms and their products are used as the active (effective) ingredients of disinfectants.
3.5
CAS code chemicalabstractsservicenumber
The registration number established by the American Chemical Abstract Service for chemical substances.
Note. This number is an important tool for retrieving information on chemical substances with multiple names. Is a substance (compound, polymer material, biological sequence), mixture or
The unique digital identification number of the alloy.
3.6
Disinfectant for drinking water
Disinfectants used for disinfecting temporary drinking water and domestic water for public life during public health emergencies.
3.7
Disinfectant for human
Disinfectant used to disinfect hands, human skin and mucous membranes.
3.8
Disinfectant formed medical instruments
In medical and health institutions, disinfectants used to disinfect equipment and supplies that come into contact with human skin, mucous membranes, organs, and tissues.
3.9
Disinfectant for environment and object surface
In homes, public places, factories, medical and health and other institutions, used to disinfect walls, which do not directly contact with food and feed,
Disinfectant for floors, objects, instruments and equipment.
3.10
Disinfectantforcontaminants
Used to sterilize the secretions, excreta, pollutants, medical waste and microbiology of patients and suspected patients in medical institutions and epidemic sources
Disinfectant for laboratory pollutants and waste.
3.11
Disinfectantforindoorair
Disinfectant used to disinfect indoor air under unmanned conditions.
3.12
Disinfectantforcentralair-condition for central air conditioning and ventilation system
Disinfectant used for disinfecting central air conditioning ventilation pipes, fan coils, and condensation systems.
3.13
Disinfectantforswimmingpoolwater
Disinfectant used to disinfect swimming pool water.
3.14
Disinfectantforcontaminatedwaterofhospital
Disinfectant used to disinfect sewage in medical institutions.
4 List of disinfectant raw materials and scope of use
4.1 The list of active (effective) ingredients of disinfectant raw materials and their scope of use are shown in Table 1.
Table 1 List of active (active) ingredients of disinfectant raw materials and recommended scope of use
5 Provisions for prohibited substances
5.1 Disinfectants are prohibited from adding drugs listed in the "Pharmacopoeia of the People's Republic of China" (2015 edition) (except disinfection and antiseptic drugs) and their
Named raw materials; human medicinal vaccines, sera or toxins and their products, etc., used to produce active or passive immunity, and used to diagnose immune status
Preparations (except lysozyme and staphylococcus enzyme); banned substances listed in the "Cosmetics Safety Technical Specifications" (2015 edition) (except iodine) (limited
(Used as a disinfectant for the human body); other prohibited substances stipulated by the national health and administrative department.
5.2 Disinfectants using sodium hypochlorite as raw materials are prohibited to use Grade B raw materials in GB/T 19106.
5.3 Disinfectant using peracetic acid as raw material, it is forbidden to use type III raw material in GB/T 19104.
5.4 For the disinfectant using trichlorohydroxydiphenyl ether as raw material, the content of dioxins should meet the requirements of the "Pharmacopoeia of the People's Republic of China" (2015 edition).
5.5 Taking sodium dichloroisocyanurate as a disinfectant for domestic drinking water in an emergency, it is forbidden to use Class II raw materials in HG/T 3779.
5.6 The raw materials for disinfectants used to disinfect human bodies, medical devices, and domestic drinking water should comply
Version), food grade, medical grade, or chemical purity and above quality requirements, the use of industrial grade raw materials is prohibited. Without the above quality level
For raw materials, industrial grade raw materials can be used temporarily, but should meet the raw material requirements of the corresponding disinfectant standards.
5.7 The raw materials used for drinking water disinfectant should also comply with GB 5749 and the Ministry of Health
The requirements of the Full Evaluation Code (2005 edition).
5.8 When the stable chlorine dioxide solution is used as a raw material for disinfecting human body, food, medical equipment and drinking water, it is prohibited to use
Class II solution in GB/T 20783.
6 Restricted substances regulations
6.1 The limited concentration of some ingredients in skin disinfectant (g/L). the content of chlorhexidine gluconate or chlorhexidine acetate ≤45; 2,4,4'-trichloro-
The content of 2-hydroxydiphenyl ether ≤20; the content of benzalkonium bromide or benzalkonium chloride ≤5.
6.2 Limit concentration (g/L) of some ingredients in mucous membrane disinfectant. chlorhexidine gluconate or chlorhexidine acetate content ≤5; 2,4,4'-trichloro-2-
The content of hydroxydiphenyl ether ≤3.5; the content of benzalkonium bromide or benzalkonium chloride ≤2.