GB 8599-1988 Technical requirements for automatic pressure steam sterilizers
Some standard content:
National Standard of the People's Republic of China
Technical conditions for automated autoclave sterilizerSpecifications for automated autoclave sterilizerThis standard applies to automated autoclave sterilizers in which the steam source enters the jacket or sterilization chamber. 1 Terminology
Sterilizer: Special equipment for sterilizing items. Sterilization chamber: Container for placing items to be sterilized. Working pressure: Steam pressure in the sterilization chamber during sterilization. Rated working pressure: Nominal pressure of the sterilizer. Recorder: Instrument for recording indicated parameters. Timer: A timing device for controlling time. 2 Technical requirements
UDC 615.478
GB 8599-88
2.1Automated pressure steam sterilizers shall comply with the requirements of this standard and be manufactured in accordance with the drawings and documents approved by the prescribed procedures. 2.2 Design and manufacturing
2.2.1 The materials, design, manufacturing, installation, use and management of the sterilizer must comply with the "Interim Regulations on Safety Supervision of Boiler and Pressure Vessels", "Regulations on Safety Supervision of Pressure Vessels" and the laws and regulations issued by the labor and personnel departments and the relevant standards of the State Drug Administration. 2.2.2 The environmental test of the electrical components of the sterilizer shall comply with the provisions of WS2-283--82 "Environmental Requirements and Test Methods for Medical Electrical Equipment" for mechanical environmental tests as Group II and climatic environmental tests as Group 1. 2.2.3 The electrical components of the sterilizer shall comply with the provisions of Class 1 equipment in WS2~295--83 "General Safety Requirements for Medical Electrical Equipment". 2.2.3.1 It should be able to withstand a withstand voltage test of 1500V AC voltage, sine wave, 50Hz for 1min. without flash or breakdown. 2.2.3.2 The ground leakage current should not be greater than 0.5mA under normal working conditions and should not be greater than 1mA under single fault conditions. 2.3 Safety
2.3.1 Interlock
2.3.1.1 When the sterilizer is under normal working conditions and the door (cover) is not locked, steam cannot enter the sterilization chamber. 2.3.1.2 The door (cover) of the sterilizer should ensure that when the pressure in the sterilization chamber is greater than 27kPa (0.28kgf/cm), the door shall not be opened. 2.3.2 Handle temperature
When the test is carried out in a room with an ambient temperature of 18-24℃, all hand wheels, handles or similar devices used by the operator should not exceed 50℃ for metal materials and 60℃ for non-metal materials. 2.3.3 Power switch
The power switch should be clearly marked and installed in a place that is easy to operate. 2.3.4 Insulation layer
The sterilizer should have an insulation layer, which should be made of non-hygroscopic materials. 2.3.5 Safety valve
The sterilizer must be equipped with a safety valve, which shall comply with the provisions of WS2-149~83 "Spring-type safety valve for pressure steam sterilization equipment".
Approved by the State Drug Administration on January 13, 1988 502
Implemented on July 1, 1988
2.4 Instruments and meters
2.4.1 Air filter
GB 859988
The sterilizer shall be equipped with an air filter, the filter material pore size shall not exceed 0.3um, and the filter effect shall not be less than 99.97%. The filter shall be installed in a position that is convenient for maintenance.
2.4.2 Sterilization chamber temperature indicator recorder
2.4.2.1 The sterilizer shall be equipped with an instrument to indicate and record the sterilization chamber temperature. 2.4.2.2 The temperature sensor of the indicator recorder shall be installed at the lowest temperature in the sterilization chamber. 2.4.2.3 The error of the temperature indicating recorder within the working range specified by the sterilizer is ±1°C. 2.4.3 Pressure gauge
2.4.3.1 The sterilizer should be equipped with a pressure gauge indicating the vacuum and pressure in the sterilization chamber. The double-door sterilizer should have a pressure gauge at each end and be installed in a position convenient for observation
2.4.3.2 The sterilizer should be equipped with a pressure gauge indicating the steam pressure in the jacket and installed in a position convenient for observation. 2.4.3.3 The pressure gauge should comply with the provisions of GB1226-76 "General Pressure Gauge". 2.4.3.4E
The accuracy of the pressure gauge should not be lower than Class 2.5.
2.4.4 Timer
The sterilizer should be equipped with a sterilization and drying timer, and its error is 10% to 0% of the preset value. 2.5 Sterilizer control system
2.5.1 The sterilizer control system should start the sterilization timer to automatically count when the preset sterilization temperature is reached, and stop counting when the temperature is lower than the sterilization temperature.
2.5.2 During the sterilization process, the control system should control the sterilization chamber temperature within the range of 0 to 3°C of the preset sterilization temperature. 2.6 Sterilization effect
The sterilizer should have a good sterilization effect and should comply with the provisions of GB860088 "Test method for sterilization effect of pressure steam sterilizer". 2.7 Vacuum sealing
Sterilizers with vacuum extraction systems should undergo a sterilization chamber vacuum sealing test. Under the maximum working vacuum degree, the leakage rate within 10 minutes shall not exceed 1.3kPa (10 mmHg).
2.8 Others
2.8.1 The appearance of the sterilizer should be neat and should not have obvious defects such as skewing, dents, bumps, scratches, etc. 2.8.2 Under working pressure, there shall be no steam leakage in any part of the sterilizer. 2.8.3 In the sterilization room, when the sterilization cart is pushed on the track of the transporter, it should be light and flexible, and there should be no jamming. 2.8.4 The electroplated parts of the sterilizer shall comply with the provisions of WS2-1-73 "Classification and Technical Conditions for Plating of Metal Parts"; ferrous metals shall use Class V and non-ferrous metals shall use Class IV. 2.8.5 The painted parts of the sterilizer shall comply with the requirements of Class 2 in ZBC30003.1-85 "Classification and Technical Conditions for Paint Coatings of Medical Devices".
2.9 Instructions
2.9.1 When the sterilizer leaves the factory, the user shall be provided with installation, maintenance and use instructions. 2.9.2 The instructions shall include the product name, product model and specifications. 2.9.3 The instructions shall include the manufacturer's name, detailed address, telephone number, registered telegram, etc. 2.9.4 The installation instructions shall include: required steam source pressure, minimum space occupied by the equipment, power supply and other requirements. 2.9.5 The maintenance instructions shall include: maintenance procedures, troubleshooting and maintenance requirements for doors, filters, recorders, steam-water separators, safety valves, pressure regulating valves and other components. 2.9.6 The operating instructions shall include: normal use procedures, operating requirements, precautions, recommended sterilization and drying time, etc. 2.10 After the sterilizer is packaged, under the condition of complying with the storage and use rules, if it cannot work normally within one and a half years from the date of leaving the factory, the manufacturer shall replace or repair it for the user free of charge. 503
3 Test method
3.1 Appearance
Observe visually.
3.2 Performance
3.2.1 Interlock test:
GB 8599-88
a Before the door of the sterilizer is locked, it should be guaranteed by a mechanism and should meet the requirements of 2.3.1.1; b. When the pressure in the sterilization chamber is greater than 27kPa, the door (cover) shall not be opened and should meet the requirements of 2.3.1.2. 3.2.2 Handle temperature test;
It should meet the requirements of 2.3.2.
3.2.3 Safety valve test:
Test according to 3.3 of WS2149--83 and should meet the requirements of 2.3.5. 3.2.4 Sterilizer control system test:
The sterilizer should perform three normal sterilization processes for each program under no-load conditions and should meet the requirements of 2.4.2, 2.4.4, 2.8.2 and 2.5.
3.2.5 Sterilization effect
Perform according to GB8600--88 and shall comply with the provisions of Article 2.6. 3.2.6 Vacuum seal inspection:
After the unloaded sterilization chamber is evacuated to the maximum working vacuum degree, stop the machine for 10 minutes and use an absolute pressure gauge with a graduation value of 133Pa (1mmHg) to test, which shall comply with the provisions of Article 2.7.
3.2.7 Environmental test:
Perform the test according to the method specified in WS2-28382 and shall comply with the provisions of Article 2.2.2. 3.2.8 Insulation inspection:
Perform the test according to the method specified in WS2-295-83 and shall comply with the provisions of Article 2.2.3. 3.2.9 Simulate the use action and shall comply with the provisions of Article 2.8.3. 3.2.10 Paint inspection:
Perform in accordance with the provisions of ZBC30003.2~30003.6 "Methods for Determination of Paint Coatings on Medical Devices". Inspection rules
4.1 The sterilizer must be inspected by the manufacturer's technical inspection department and can only be submitted for acceptance after passing the inspection. 4.2 Sterilizers must be submitted for inspection in batches, and the batch size shall be as specified in the order contract. The inspection quantity shall be as specified in Table 1. Table 1
Inspection quantity, units
>100～200
>200～500
Inspection quantity as a percentage of the inspection quantity of each batch 10
4.3 During acceptance, inspection shall be carried out item by item as specified in Table 2. 504
Not less than 1 unit
Inspection items
GB 8599—88
Inspection scope
2.3.3, 2.4.2, 2.8.1, 2.8.4, 2.8.5 Clauses 2.5, 2.7, 2.2.3, 2.3.1, 2.3.2, 2.3.5, 2.4.4, 2.8.2, 2.8.3, 2.4.2.3 Note
2.2.3 The manufacturer shall provide the test report
4.4 According to the inspection items and inspection scope specified in Article 4.3, during the acceptance process, if one of the performance items is found to be non-compliant with the requirements of this standard, the batch of products shall be returned and reclassified; if one of the appearance items is found to be non-compliant with the requirements of this standard, double the number of products shall be sampled and repeated inspection shall be carried out according to the unqualified items. If it still does not meet the requirements of this standard, the batch of products shall be returned and reclassified.
4.5 After classification and reorganization, it can be submitted for inspection again. During the re-inspection, the provisions of Article 4.2 shall apply. Double the number of samples shall be taken for inspection. If the products do not meet the requirements of Article 44, the batch of products shall not be accepted. 4.6 During the acceptance process, if the two parties have disputes over whether the product quality is qualified, arbitration may be conducted by the relevant units. 4.7
Routine tests should be carried out in the following cases: a.
Before the new product is put into production (including the transfer of old products to other factories); for products in continuous production, no less than once a year, when the product is put into production again after a year;
When there are major changes in design, process or materials. In addition to all acceptance inspection items, routine tests shall also be carried out in accordance with the provisions of Articles 2.6, 2.2.2 and 2.8.5. 5 Marking, packaging, transportation, storage
Each sterilizer should have a nameplate in an appropriate and obvious position. The nameplate should have the following marks: manufacturer's name, trademark and factory address;
product name;
product model;
rated working pressure and design pressure;
power supply voltage and current;
date of manufacture and serial number;
total weight (kg).
The surface of the electroplated parts of the sterilizer should be coated with a neutral rust preventive. And use a neutral plastic film to cover the sterilizer as a whole. Each sterilizer should be accompanied by a certificate of inspection, an instruction manual and a packing list, as well as relevant random documents, which should be packed in a neutral plastic bag and placed in the sterilizer.
The certificate of inspection should have the following marks:
manufacturer's name or trademark;
product name;
inspection date;
inspector code.
5.4 Each sterilizer should be covered with a neutral plastic film and packed in a wooden box, or as specified in the order contract. And should meet the following requirements: 5.4.1
Impurities.
The sterilizer should be cleaned before packing, and no water or impurities are allowed. Seal the pipe drain switch, screw holes, etc. to prevent them from entering. The wooden box should have moisture-proof and rain-proof devices to ensure that the product is not naturally damaged. There should be sliding wood at the bottom of the box. 5.4.2
5.4.3 The sterilizer must be firmly positioned in the wooden box, and the pressure wood and the product contact surface should be padded with soft padding of appropriate thickness to prevent loosening and scratches during transportation 505
.
5.4.4 The wooden box should have the following signs:
's regulations.
Manufacturer's name and address:
Product name and specifications;www.bzxz.net
Factory number;
Factory date;
Volume (length × width × height);
Net weight and gross weight:
GB 8599--88
Words or signs such as "Handle with care", "Upward" and "Avoid moisture". The signs should comply with GB191-85 "Packaging, storage and transportation graphic signs". The words and signs on the box should not be blurred due to long-term use. 5 Transportation requirements shall be in accordance with the order contract.
The packaged sterilizer should be stored in a room with a relative humidity not exceeding 80%, no corrosive gas and good ventilation. 5.6
Additional instructions:
This standard is under the jurisdiction of Shanghai Medical Device Research Institute. This standard was drafted by Shandong Xinhua Medical Device Factory. The main drafter of this standard is Feng Dongqi.Shanghai Institute of Medical Devices is responsible for this standard. Shandong Xinhua Medical Devices Factory is responsible for drafting this standard. The main drafter of this standard is Feng Dongqi.Shanghai Institute of Medical Devices is responsible for this standard. Shandong Xinhua Medical Devices Factory is responsible for drafting this standard. The main drafter of this standard is Feng Dongqi.
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