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.
All technical contents of this standard are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 27949-2011 Hygienic requirements for medical items disinfection. The following main technical changes have been made with respect to GB/T 27949-2011:
——The inapplicable scope in Clause “Scope” is changed as “not applicable to disinfecting instruments with disinfection factor generating devices and gases or disinfection and sterilization products that have effect after gasification/vaporization under specific conditions” (see Clause 1);
——The normative references are modified;
——Some terms are deleted;
——The requirements for raw materials are modified;
——The requirements for sensory properties of disinfectant are deleted, and the relevant requirements are reflected in 5.2;
——The requirements of valid period are modified (see 5.2);
——"Compatibility of disinfectants and instruments" is added (see 5.4);
——The requirements of strain number or virus strain of experimental microorganisms are added in the technical requirements (see 5.5);
——"Requirements for disinfectants matched with disinfecting apparatus" is added (see 5.6);
——"Continuous use stability" is listed separately (see 5.7);
——The test bases such as Technical specification for disinfection effect inspection of endoscope cleaning disinfector (Trial) are added in the inspection method;
——The application method is revised;
——The Clause “Labeling” is added and corresponding requirements are stated (see Clause 8);
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
The previous edition of this standard is as follows:
——GB/T 27949-2011.
General requirements of disinfectant of medical instruments
1 Scope
This standard specifies the raw material requirements, technical requirements, inspection methods, application methods, labeling, packaging, storage and transportation requirements of chemical disinfectants for medical instruments disinfection and sterilization.
This standard is applicable to disinfectant of medical instruments.
This standard is not applicable to disinfection instruments with disinfection factor generating devices and gases or disinfection and sterilization products that have effect after gasification/vaporization under specific conditions.
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 Packaging - Pictorial marking for handling of goods
GB 30689 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
GBZ 2 (All parts) Occupational exposure limits for hazardous agents in the workplace
WS 507 Regulation for cleaning and disinfection technique of flexible endoscope
Technical standard for disinfection (Edition 2002) [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)]
Technical specification for disinfection effect inspection of endoscope cleaning disinfector (Trial) [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2003] No.330)]
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
medical instruments
apparatus, equipment, appliances, materials or other articles used alone or in combination for human body
Note: Medical instruments are classified into critical ones, semi-critical ones and non-critical ones according to the degree of risk of infection during use.
3.2
disinfectant of medical instruments
chemical used for treatment of medical instruments to achieve disinfection or sterilization requirements
4 Requirements for raw materials
4.1 Disinfectant raw materials shall comply with the Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV), corresponding national standards or professional standards and other relevant regulations, and have corresponding qualification certificates.
4.2 Production water shall be purified water.
5 Technical requirements
5.1 Physical and chemical indexes
The content of active ingredients and pH value of products shall meet the relevant national standards, specification and product quality requirements.
5.2 Valid period
The valid period of a well-packaged product shall not be less than 12 months, and the sensory index, pH value, etc. of the product shall not be obviously changed during storage.
5.3 Corrosiveness to metals
When disinfectant is used for disinfection and sterilization of metal instruments, it shall be basically non-corrosive to stainless steel and basically non-corrosive or only slightly corrosive to metals such as carbon steel, aluminum and copper at the application dose.
5.4 Compatibility of disinfectants and instruments
5.4.1 Disinfectants used for a long time should have good compatibility with overall medical instruments and components, and with no obvious corrosivity.
5.4.2 Disinfectants for special medical instruments shall have no obvious damage to components, and medical instruments shall be tolerant to them.
5.5 Microbiological sterilization index
5.5.1 Requirements for sterilizing microorganisms in laboratories
According to the category of sterilized microorganisms and application scope marked on the product label and instruction book, carry out corresponding disinfection test of indicating microorganisms. The sterilization effect shall meet the requirements of Table 1 under the dose specified in the product instruction book. Among them, the test conditions of sterilant are the minimum action concentration and 50% of shortest action time specified in the instruction book, and the action concentration and action time of disinfectant shall meet those specified in the instruction book.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Inspection methods
7 Application methods
8 Labeling
9 Packaging, storage and transportation
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.
All technical contents of this standard are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 27949-2011 Hygienic requirements for medical items disinfection. The following main technical changes have been made with respect to GB/T 27949-2011:
——The inapplicable scope in Clause “Scope” is changed as “not applicable to disinfecting instruments with disinfection factor generating devices and gases or disinfection and sterilization products that have effect after gasification/vaporization under specific conditions” (see Clause 1);
——The normative references are modified;
——Some terms are deleted;
——The requirements for raw materials are modified;
——The requirements for sensory properties of disinfectant are deleted, and the relevant requirements are reflected in 5.2;
——The requirements of valid period are modified (see 5.2);
——"Compatibility of disinfectants and instruments" is added (see 5.4);
——The requirements of strain number or virus strain of experimental microorganisms are added in the technical requirements (see 5.5);
——"Requirements for disinfectants matched with disinfecting apparatus" is added (see 5.6);
——"Continuous use stability" is listed separately (see 5.7);
——The test bases such as Technical specification for disinfection effect inspection of endoscope cleaning disinfector (Trial) are added in the inspection method;
——The application method is revised;
——The Clause “Labeling” is added and corresponding requirements are stated (see Clause 8);
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
The previous edition of this standard is as follows:
——GB/T 27949-2011.
General requirements of disinfectant of medical instruments
1 Scope
This standard specifies the raw material requirements, technical requirements, inspection methods, application methods, labeling, packaging, storage and transportation requirements of chemical disinfectants for medical instruments disinfection and sterilization.
This standard is applicable to disinfectant of medical instruments.
This standard is not applicable to disinfection instruments with disinfection factor generating devices and gases or disinfection and sterilization products that have effect after gasification/vaporization under specific conditions.
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 Packaging - Pictorial marking for handling of goods
GB 30689 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
GBZ 2 (All parts) Occupational exposure limits for hazardous agents in the workplace
WS 507 Regulation for cleaning and disinfection technique of flexible endoscope
Technical standard for disinfection (Edition 2002) [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)]
Technical specification for disinfection effect inspection of endoscope cleaning disinfector (Trial) [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2003] No.330)]
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
medical instruments
apparatus, equipment, appliances, materials or other articles used alone or in combination for human body
Note: Medical instruments are classified into critical ones, semi-critical ones and non-critical ones according to the degree of risk of infection during use.
3.2
disinfectant of medical instruments
chemical used for treatment of medical instruments to achieve disinfection or sterilization requirements
4 Requirements for raw materials
4.1 Disinfectant raw materials shall comply with the Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV), corresponding national standards or professional standards and other relevant regulations, and have corresponding qualification certificates.
4.2 Production water shall be purified water.
5 Technical requirements
5.1 Physical and chemical indexes
The content of active ingredients and pH value of products shall meet the relevant national standards, specification and product quality requirements.
5.2 Valid period
The valid period of a well-packaged product shall not be less than 12 months, and the sensory index, pH value, etc. of the product shall not be obviously changed during storage.
5.3 Corrosiveness to metals
When disinfectant is used for disinfection and sterilization of metal instruments, it shall be basically non-corrosive to stainless steel and basically non-corrosive or only slightly corrosive to metals such as carbon steel, aluminum and copper at the application dose.
5.4 Compatibility of disinfectants and instruments
5.4.1 Disinfectants used for a long time should have good compatibility with overall medical instruments and components, and with no obvious corrosivity.
5.4.2 Disinfectants for special medical instruments shall have no obvious damage to components, and medical instruments shall be tolerant to them.
5.5 Microbiological sterilization index
5.5.1 Requirements for sterilizing microorganisms in laboratories
According to the category of sterilized microorganisms and application scope marked on the product label and instruction book, carry out corresponding disinfection test of indicating microorganisms. The sterilization effect shall meet the requirements of Table 1 under the dose specified in the product instruction book. Among them, the test conditions of sterilant are the minimum action concentration and 50% of shortest action time specified in the instruction book, and the action concentration and action time of disinfectant shall meet those specified in the instruction book.
Contents of GB 27949-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Inspection methods
7 Application methods
8 Labeling
9 Packaging, storage and transportation
