Operational Specifications for Disinfection and Sterilization of Dental Instruments
Technical specifications for disinfection and sterilization of oral instruments
1．Scope
This standard specifies the management requirements, basic principles, operating procedures, sterilization monitoring, release of sterilized items, and requirements for storage of dental instruments.
This standard applies to all types of medical institutions that provide oral disease prevention, diagnosis, and treatment services. For centralized supply of disinfection supply centers, the disposal methods of oral instruments can be implemented with reference to this standard.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.
GB15982 Sanitary Standards for Hospital Disinfection
GB / T19633 Packaging of final sterilized medical devices
WS310.2 Hospital Disinfection Supply Center Part 2: Technical specifications for cleaning, disinfection and sterilization
WS310.3 Hospital Disinfection Supply Center Part 3: Monitoring Standards for Cleaning, Disinfection and Sterilization Effectiveness
WS / T367 Technical specifications for disinfection of medical institutions
YY0646-2008 / EN13060: 2004 small steam sterilizer automatic control type
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 dental devices
Reusable devices, appliances and articles for the prevention, diagnosis and treatment of oral disorders and oral health.
3.2 small dental devices
Smaller-sized dental instruments, such as various types of needles and root canals.
3.3 Dental Handpiece (general term) handpiece, dental (general term)
Hand-held tool holder for transferring (with or without conversion) the energy required for work to a dental tool or appliance.
3.4 root-canal instruments
Apparatus for exploring, penetrating, preparing or filling the root canal, such as root canal files, root canal expanders, smooth canal needles
3.5 dental scaler
Manual or electric dental instruments specifically designed and / or used to remove tartar from the surface of teeth.
3.6 critical dental instruments
Oral instruments that penetrate soft tissue, come into contact with bone, enter or come into contact with blood or other sterile tissue.
3.7 Semicritical dental instruments
Contact with intact mucosa without entering sterile tissues, organs, and bloodstream of the human body, and do not touch oral instruments that damage the skin and mucous membranes.
3.8 Noncritical dental instruments
It does not touch the patient’s mouth or indirectly contacts the patient’s mouth, and participates in oral diagnosis and treatment services. Although there is microbial contamination, it is generally not harmful. Only when it is contaminated by a certain amount of pathogenic microorganisms, it can cause harm to oral instruments.
3.9 Automatic control type of small pressure steam sterilizer (hereinafter referred to as small sterilizer)
Automatic control of steam generated by electric heating or external steam. Small automatic control steam sterilizer with sterilization chamber volume not exceeding 60L.
3.10 hollow load A
Single-end opening load whose ratio of length (L) to hole diameter (D) is greater than 1, less than or equal to 750 (1≤L / D≤750) and the length is not more than 1500mm (L≤1500mm); The ratio of the load to the diameter of the hole is greater than 2, less than or equal to 1500mm (2≤L / D≤1500) and the length is not greater than 3000mm (L≤3000mm), and it is not a Class B cavity load.
Example 1: Dental handpieces are Class A cavity-loaded instruments.
3.11 hollow load B
Single-end open-hole load, whose ratio of length (L) to hole diameter (D) is greater than or equal to 1, less than or equal to 5 (1≤L / D≤5), and the hole diameter is not less than 5mm (D≥5mm); or both ends The ratio of the opening load’s length to the hole diameter is greater than 2, less than or equal to 10mm (2≤L / D≤10), and the hole diameter is not less than 5mm (D≥5mm).
3.12 processing variable
Changes in the conditions of the sterilization process will affect the effectiveness of killing microorganisms.
3.13 verification
Confirmation that the specified requirements have been met by providing objective evidence.
4 Management requirements
4.1 Medical Institutions
4.1.1 The management system for the disinfection and sterilization of oral instruments in this institution shall be established.
4.1.2 An independent device processing area shall be established.
4.1.3 Full-time or part-time dental equipment disinfection staff should be provided according to the workload of oral diagnosis and treatment services. Disinfection and sterilization staff should participate in pre-job training and continuing education, and the training content should be at least as listed in Appendix A.
4.2 Instrument processing area
4.2.1 It should match the scope and workload of oral diagnosis and treatment services, and the layout should meet the requirements of hospital infection prevention and control.
4.2.2 The area is divided into recycling and cleaning area, maintenance packaging and sterilization area, and article storage area.
4.2.2.1 Recycling and cleaning area is responsible for the recovery, classification, cleaning and drying of instruments.
4.2.2.2 Maintenance packaging and sterilization area is responsible for equipment maintenance, inspection, packaging, disinfection and / or sterilization.
4.2.2.3 Article storage area stores sterilized and sterilized items, as well as disposable sanitary products removed from packaging. Oral clinics with less workload may not have an item storage area. After disinfection and sterilization, items are placed directly in the instrument storage vehicle.
4.2.3. There should be physical barriers in the recycling and cleaning area, maintenance packaging and sterilization area.
4.2.4 The design of the working process should be from dirty to clean, the decorative materials should be water-resistant and easy to clean, and water, electricity and gas pipelines should be reserved according to the equipment.
4.3 Equipment and facilities
4.3.1 The equipment and facilities shall be reasonably configured according to the actual situation of oral diagnosis and treatment services, and shall comply with relevant national standards or regulations.
4.3.2 It should be equipped with dirt recovery equipment, manual cleaning pool, workbench, ultrasonic cleaner and sterilization equipment.
4.3.3 It should be equipped with mechanical cleaning and disinfection equipment, automatic oil injection curing machine for dental mobile phones, medical heat sealer, drying equipment, etc.
4.4 Consumables
4.4.1 Cleaning agent: It should meet the relevant national standards or regulations. According to the material of the device and the type of pollutants, choose a cleaning agent suitable for oral instruments.
4.4.2 Disinfectant: A legal and effective disinfectant should be selected.
4.4.3 Lubricant: Dental mobile phones should choose special cleaning lubricants, and use should follow the instructions provided by the manufacturer or supplier. Other oral instruments are available with water-soluble lubricants.
4.4.4 Packaging materials: disposable medical crepe paper, paper-plastic bags, paper bags, textiles, non-woven fabrics, etc. shall meet the requirements of GB / T19633; dental instrument boxes shall have a microbial barrier function and be suitable for various types of needles and root canal appliances Wait for the placement of the instrument.
4.4.5 Disinfection and sterilization monitoring materials: should be legal and effective and used within the validity period.
5 Basic principles of oral instrument processing
5.1 Dental instruments should be disinfected and / or sterilized by one person, one use, and one.
5.2. High-risk oral instruments should reach the sterilization level.
5.3. Moderately dangerous oral instruments should reach sterilization level or high-level disinfection.
5.4 Low-risk oral instruments should reach medium or low level disinfection.
5.5 The classification and sterilization requirements of oral instruments should meet the requirements of Appendix B.
6 Oral instrument processing operation process
6.1 Recovery
6.1.1 After using, oral instruments should be placed separately from waste and recycled in a timely manner.
6.1.2 Dental instruments should be classified and placed according to the material, function and processing method of the instrument.
6.1.2.1 Dental instruments (such as small dental instruments, curettes, etc.) with complex structures and difficult to clean should be placed in a moisturizing state. The moisturizing liquid can be selected from domestic drinking water or enzyme detergents.
6.1.2.2 The dental handpiece, electric dental scaler and electric knife should be decontaminated initially and stored in a dry recovery container.
6.1.2.3 Other instruments can be placed in special recycling containers.
6.1.3 The recovery container should be cleaned, disinfected and dried after each use.
6.2 Cleaning
6.2.1 The cleaning methods of oral instruments include manual cleaning and machine cleaning (including ultrasonic cleaning). Manual and ultrasonic cleaning methods should meet the requirements of Appendix C; mechanical cleaning methods should follow the manufacturer’s instructions or instruction manual.
6.2.2 Non-power oral instruments can choose mechanical cleaning methods
6.2.3 Dental instruments with power supply, precision and complicated dental instruments should choose manual cleaning.
6.2.3.1 Detachable instruments should be cleaned separately after disassembly, such as electric tooth cleaners.
6.2.3.2 The manual cleaning method should be selected for the handle of electric dental scaler.
6.2.4 Ultrasonic cleaning is preferred for small dental instruments and other complicated structures. For the cleaning method, see Appendix C.2.
6.2.5 The cleaning of dental handpiece shall meet the requirements of Appendix D.
6.3 Drying
6.3.1 Drying equipment should be selected for drying equipment. Select the appropriate drying temperature according to the materials of instruments and appliances. The drying temperature for metals is 70 ° C to 90 ° C; the drying temperature for plastics is 65 ° C to 75 ° C.
6.3.2 Without drying equipment and heat-resistant instruments and appliances, low-fiber rags can be used for drying.
6.4 Inspection and maintenance
6.4.1 The dry oral instruments should be inspected visually or using a magnifying glass with a light source. The surface of the instrument, the spiral structure, and the joint should be free of stains, water stains and other residual substances and rust spots. Instruments that have failed cleaning quality should be re-processed; damaged or deformed instruments should be replaced in a timely manner.
6.4.2 The maintenance of dental handpieces shall meet the requirements of 6. Appendix D.
6.5 Disinfection method selection
6.5.1 The method of physical disinfection should be moist heat disinfection, and the parameters of moist heat disinfection should meet the requirements of WS310.2;
6.5.2 The chemical disinfection method shall meet the requirements of WS / T367-2012.
6.6 Packing
6.6.1 Packaging materials should be selected according to the characteristics of the device and the frequency of use.
6.6.2 Low- and medium-risk oral instruments can be left unpackaged, and directly stored in a spare clean container after disinfection or sterilization.
6.6.3 Dental instruments should be packed in a dental instrument box.
6.6.4 Packet Requirements
6.6.4.1 There should be sterilization chemical indicators on the outside of the package, and it should be marked with the item name, packer, sterilizer number, sterilization batch, sterilization date and expiry date. Bacteria number.
6.6.4.2 There shall be chemical indicators inside and outside the package of the oral outpatient surgical kit.
6.6.4.3 The paper and plastic bags shall be completely sealed when packaged, with a seal width of ≥6mm, and the equipment in the package shall be ≥2.5cm from the seal of the package. The paper bag should be sealed completely.
6.6.4.4 The accuracy of the parameters of medical heat sealers should be checked before daily use.
6.7 Sterilization method selection
6.7.1 For oral instruments, pressure steam sterilization should be preferred, and small-scale sterilizers should meet the requirements of Appendix E.
6.7.2 Carbon steel equipment should choose dry heat sterilization.
6.7.3 Other sterilization methods shall meet the requirements of WS310.2.
7 Monitoring requirements
7.1 Disinfection monitoring
7.1.1 Damp heat disinfection The temperature and time shall be monitored and recorded each time.
7.1.2 Chemical disinfection The concentration of chemical disinfectant, disinfection time should be regularly monitored and recorded according to the type of disinfectant.
7.1.3 Monitoring of disinfection effect The items used directly after disinfection shall be monitored at least quarterly. The monitoring methods and results shall be in accordance with the requirements of WS / T367-2012.
7.2 Sterilization monitoring
7.2.1 The monitoring of the small sterilizer meets the requirements of Appendix E.
7.2.2 The monitoring of other sterilizer sterilization methods shall comply with the relevant provisions of WS 310.3.
7.2.3 Each record of sterilization cycle operation shall be documented. The document record shall be kept for 3 years. For the format of the record, refer to Appendix F.
8 Disinfection and Sterilization
8.1 Release of Disinfectant
8.1.1 Mechanical thermal disinfection should check the rated parameters (temperature, time), the obtained parameters meet the requirements, and the disinfected items can be released.
8.1.2 When disinfecting articles with chemical disinfectants, they should meet the disinfection time and concentration requirements of WS / T367, and the articles can be released.
8.2 Release of sterilized articles
8.2.1 After the end of each sterilization cycle, all physical parameters and chemical indicators should be checked. The displayed data and indicators should be consistent with the specified sterilization parameters before the sterilized items are released.
8.2.2 The various monitoring or parameters of the sterilization cycle should not be released when they are unsatisfactory. The cause of sterilization failure should be found, and physical and chemical monitoring should be performed after readjustment. The sterilizer can be used again after passing the test. Monitor and record the entire process.
9 instrument storage
9.1 The storage area should be equipped with an item storage cabinet (shelf) or a storage cart, and it should be cleaned and disinfected weekly.
9.1.1 The sterilized articles and sterilized articles shall be placed separately and clearly marked.
9.1.2 The storage validity period of sterile articles in sterilized packaging is shown in the table below.
Aseptic validity of packaging materials
type of packaging
Textile material and dental instrument box
Disposable paper bag
Disposable crepe paper and medical non-woven fabric
Disposable paper bag
Validity period (d)
9.1.3 Highly dangerous oral instruments in bare sterilization and general container packaging should be used immediately after sterilization
