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WS/T 367-2012 English PDF

WS/T 367-2012_English: PDF (WS/T367-2012)
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WS/T 367-2012English150 Add to Cart 0--9 seconds. Auto-delivery Regulation of disinfection technique in healthcare settings Valid WS/T 367-2012


BASIC DATA
Standard ID WS/T 367-2012 (WS/T367-2012)
Description (Translated English) Regulation of disinfection technique in healthcare settings
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C05
Classification of International Standard 11.020
Word Count Estimation 41,450
Quoted Standard GB/T 16886.7; GB 19258; GB/T 19633; GB 50333; WS 310.1; WS 310.2; WS 310.3; WS/T 311; WS/T 313; YY/T 0506.1; YY/T 0698.2; YY/T 0698.4; YY/T 0698.5; YY/T 0698.8
Drafting Organization Peking University First Hospital
Administrative Organization ?PRC Ministry of Health
Regulation (derived from) ?Health-Communication (2012) 6; Industry Standard Filing Announcement 2012 No.5 (Total No.149)
Summary This standard specifies the sterilization of medical institutions management requirements. The basic principles of disinfection and sterilization, washing and cleaning, disinfection and sterilization methods. Cleaning, effect of disinfection and steriliza


WS/T 367-2012 WS HEALTHCARE INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.020 C 05 Regulation of disinfection technique in healthcare settings ISSUED ON. APRIL 05, 2012 IMPLEMENTED ON. AUGUST 01, 2012 Issued by. Ministry of Health of the PRC Table of contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 5  4 Management requirements... 11  5 Basic principles of disinfection and sterilization ... 12  6 Washing and cleaning ... 15  7 Common disinfection and sterilization methods ... 16  8 Sterilization of critical items ... 16  9 Disinfection of semi-critical items ... 18  10 Disinfection of non-critical items ... 19  11 Disinfection of item and environment contaminated by prion, gas gangrene and sudden unexplained infectious disease ... 20  12 Disinfection of skin and mucosa ... 23  13 Cleaning and disinfection of ground and item surface ... 26  14 Disinfection of cleaning supplies ... 27  Appendix A (Normative) Cleaning, disinfection and sterilization effects monitoring ... 28  Appendix B (Informative) Disinfection test reagents and medium formulations ... 40  Appendix C (Normative) Commonly used disinfection and sterilization methods ... 45  Foreword This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was formulated in accordance with the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases. This standard was proposed by the Hospital Infection Control Standard Professional Committee of the Ministry of Health. The drafting organizations of this standard. Peking University First Hospital, China Disease Control and Prevention Center, Academy of Military Medical Sciences - Institute of Disease Control, Hubei Provincial Health Department Health Supervision Bureau, Zhejiang Provincial Disease Control and Prevention Center, Ministry of Health - Hospital Management Institute, Zhejiang University Medical Hospital Affiliated Second Hospital, Shanghai Ruijin Hospital, Capital Medical University - Beijing Chaoyang Hospital, Xiamen University First Affiliated Hospital. The main drafters of this standard. Li Liuyi, Zhang Liubo, Yao Chushui, Chen Shunlan, Ban Haiqun, Hu Guoqing, Zhang Yu, Ding Yanming, Lu Qun, Qian Liming, Liu Kun, Xing Shuxia, Ren Wuai, Huang Jingxiong, Jia Huixue, Yao Hui, Huang Huiping. Regulation of disinfection technique in healthcare settings 1 Scope This standard specifies the management requirements for disinfection of medical institutions; the basic principles of disinfection and sterilization; washing and cleaning, disinfection and sterilization methods; cleaning, disinfection and sterilization effect monitoring, etc. This standard applies to all types of medical institutions of all levels and all types. 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 Standard. GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals GB 19258 Ultraviolet germicidal lamp GB/T 19633 Packaging for terminally sterilized medical devices GB 50333 Architectural technical code for hospital clean operating department WS 310.1 Central sterile supply department (CSSD) - Part 1. Management standard WS 310.2 Central sterile supply department (CSSD) - Part 2. Standard for operating procedure of cleaning, disinfection and sterilization WS 310.3 Central sterile supply department (CSSD) - Part 3. Surveillance standard for cleaning, disinfection and sterilization WS/T 311 Technique standard for isolation in hospitals WS/T 313 Standard for hand hygiene for healthcare workers in healthcare settings YY/T 0506.1 Surgical drapes gowns and clean air suits for patient clinical staff and equipment - Part 1. General requirements for manufacturers processors and products YY/T 0698.2 Packaging materials for terminal sterilized medical devices - Part 2. Sterilization wrap - Requirements and test methods YY/T 0698.4 Packaging materials for terminal sterilized medical devices - Part 4. Paper bags - Requirements and test methods YY/T 0698.5 Packaging materials for terminal sterilized medical devices - Part 5. Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods YY/T 0698.8 Packaging materials for terminal sterilized medical devices - Part 8. Reusable sterilization containers for steam sterilizers - Requirements and test methods 3 Terms and definitions The following terms and definitions apply to this document. 3.1 Cleaning It refers to the process of removing the organic matter, inorganic matter and visible pollutants from the surface of an object. 3.2 Washing It refers to the whole process of removing the containments from the treatment instrument, appliance, and items, including washing, cleaning, rinsing and final rinsing. 3.3 Detergent 3.15 Non-critical items It refers to the items contacting with the complete skin BUT not contacting with mucosa, such as stethoscope, sphygmomanometer cuff; bed fence, bed and bedside cabinet, bedding; wall, ground; spittoon (cup) and toilet. 3.16 Sterilization level It refers to the sterility assurance level which is reached by killing all microorganisms including bacterial spores. Methods to achieve sterilization levels normally include such physical sterilization methods as heat sterilization and radiation sterilization AND the sterilization methods of using such chemical sterilizers as ethylene oxide, hydrogen peroxide, formaldehyde, glutaraldehyde, peracetic acid and so on to conduct sterilization at the specified conditions with appropriate concentration and effective time of action. 3.17 High level disinfection It refers to killing of all bacterial propagules including mycobacteria, viruses, fungi and their spores, and the vast majority of bacterial spores. The normally used methods to reach to high level disinfection include using the chemical disinfectant such as chlorine preparations, chlorine dioxide, o-phthalaldehyde, peracetic acid, hydrogen peroxide, ozone, iodine tincture and so on, which can achieve sterilization effects, to conduct disinfection at the specified conditions with appropriate concentration and effective time of action. 3.18 Middle level disinfection It refers to the killing of a variety of pathogenic microorganisms other than bacterial spores, including mycobacteria. The methods normally used to achieve to the middle level disinfection include using of iodine disinfectants (iodophor, chlorhexidine iodine, etc.), alcohols and chlorhexidine compound, compound of alcohols and quaternary ammonium compounds, phenols and other disinfectants, to conduct disinfection at the specified conditions with appropriate concentration and effective time of action. aggregate on a solid culture medium, which is used to express the number of viable bacteria. 4 Management requirements 4.1 The medical institutions shall, in accordance with the requirements of this regulation AND combining with the actual situation of the unit, establish the scientific and practical disinfection & sterilization system and standard operating procedures, AND make them implemented. 4.2 The medical institutions shall enhance the training of the medical staff and disinfection & sterilization staff. Training shall include the significance of disinfection and sterilization work on the prevention and control of the nosocomial infection, the requirements of relevant laws and regulations, the basic principles and knowledge of disinfection and sterilization, and the occupational protection in disinfection and sterilization work. 4.3 The diagnosis and treatment instrument, appliances and items used by the medical institutions shall comply with the following requirements. a) The diagnosis and treatment instrument, appliances and items entering into human body’s aseptic tissue, organs, lacunae, OR contacting with the damaged skin, damaged mucosa, and tissue shall be sterilized; b) The diagnosis and treatment instrument, appliances and items contacting with complete skin and intact mucosa shall be disinfected. 4.4 The disinfected products used by the medical institutions shall comply with ... ......

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