GB 27954-2020 English PDF (GB27954-2020)

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GB 27954-2020: General requirements for disinfectant of mucous membrane
GB 27954-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB 27954-2011
General Requirements for Disinfectant of Mucous
Membrane
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: NOVEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Raw Material Requirements ... 6
4 Technical Requirements ... 6
5 Inspection Methods ... 8
6 Use Methods ... 8
7 Marking ... 9
Appendix A (Informative) Disinfection Method of Mucous Membrane for
Commonly-Used Disinfectant ... 10
General Requirements for Disinfectant of Mucous
Membrane
1 Scope
This Standard specifies the raw material requirements, technical requirements,
inspection methods, use methods and marking for disinfectant of mucous membrane.
This Standard is applicable to disinfectants used by medical and health institutions to
disinfect mucous membrane.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 26367 Hygienic Standard for Biguanides Disinfectants
GB/T 26368 Hygienic Standard for Iodine Disinfectants
GB/T 26369 Hygienic Standard for Quaternary Ammonium Disinfectant
GB/T 27947 Hygienic Requirements for Phenol Disinfectant
GB 27951 Hygienic Requirements for Skin Disinfectant
WS 628 Technical Requirements for the Hygiene and Safety Evaluation of
Disinfectant Products
Pharmacopoeia of the People’s Republic of China
Technical Standard for Disinfection (2002 Edition) [Ministry of Health (WFJF [2002]
No.282)]
Hygiene Regulation for Disinfection Products Production Enterprises (2009
Edition) [Ministry of Health (WJDF [2009] No.53)]
Notice on Provisions for the Limit Values of Some Ingredients for the Disinfectant
of Skin Mucous Membrane Issued by the Ministry of Health [Ministry of Health
(WFJF [2003] No.214)]
Safety and Technical Standards for Cosmetics (2015 Edition) (State Food and
Drug Administration)
3 Raw Material Requirements
3.1 Main germicidal ingredients
Iodine-containing disinfectants used for mucous membrane disinfection shall meet the
requirements of GB/T 26368; guanidine disinfectants shall meet the requirements of
GB/T 26367; quaternary ammonium salt disinfectants shall meet the requirements of
GB/T 26369; phenolic disinfectants shall meet the requirements of GB/T 27947.
Other disinfectants used for mucous membranes shall comply with the Notice on
Provisions for the Limit Values of Some Ingredients for the Disinfectant of Skin Mucous
Membrane Issued by the Ministry of Health and other relevant national standards and
regulations.
3.2 Prohibited substances
All kinds of prescription drugs such as antibiotics, antifungal drugs, antiviral drugs,
hormones and their raw materials with the same name, etc. and prohibited substances
that is prescribed by the health administrative department.
3.3 Production water
It shall meet the requirements of purified water specified in Pharmacopoeia of the
People's Republic of China.
3.4 Other non-sterilizing factor ingredients or excipients
It shall comply with the Hygiene Regulation for Disinfection Products Production
Enterprises (2009 Edition) and other relevant national standards and regulations.
3.5 Limits of lead, mercury and arsenic
Lead ≤10 mg/kg, mercury ≤1 mg/kg, arsenic ≤2 mg/kg.
4 Technical Requirements
4.1 Physical and chemical indicators
The physical and chemical indicators of the disinfectant, such as effective ingredient
equal to 10 CFU/mL; and hemolytic streptococcus, Staphylococcus aureus,
Pseudomonas aeruginosa shall not be detected during routine test. When suspected
of being contaminated by pathogenic microorganisms during use, the corresponding
target microorganisms shall be tested and none must be detected.
5 Inspection Methods
5.1 Active ingredient content
It shall be tested according to the corresponding standard methods of sterilization
active ingredients.
5.2 Stability
It shall be tested according to the provisions of Technical Standard for Disinfection
(2002 Edition).
5.3 pH
It shall be tested according to the provisions of Technical Standard for Disinfection
(2002 Edition).
5.4 Determination of Limits of lead, mercury and arsenic
It shall be tested according to the methods specified in Safety and Technical Standards
for Cosmetics (2015 Edition)
5.5 Microbial killing test
It shall be tested according to the provisions of Technical Standard for Disinfection
(2002 Edition).
5.6 Safety test
It shall be tested according to the provisions of Technical Standard for Disinfection
(2002 Edition).
5.7 Microbial contamination test
It shall be tested according to the method specified in GB 27951.
6 Use Methods
It is suitable for wiping, rinsing and disinfecting mucous membranes. For mucous
membrane disinfection methods of the commonly-used disinfectant, see Appendix A.