GB8599-2023 Standard Test Package

GB8599-2023 Standard Test PackageUsage: Used as a supplement to the Process Challenge Device (PCD) for large pressure steam sterilizers using standard test kits (7kg BD kits), small pressure steam sterilizers using small size test kits (4kg small loads), standard biological test kits (1.5kg), full load fabric (7.5kg), stainless steel metal test kits, and cavity load tests.

The standard test package complies with the standard: the product meets the testing requirements in Appendix D of GB8599-2023 "Technical Requirements for Large Pressure Steam Sterilizers".

GB8599-2023 Standard Test PackageMain technical specifications:

D. 1 Standard Test Package:

Note 1: The standard test package is used to test whether steam can quickly and uniformly penetrate the test package when the cycle parameters reach the set values.

Note 2: Used for BD testing, small load testing, fabric drying effect testing, and combined with other materials to form a full load.

D. 1.1 The standard test package can be reused and can also be used for continuous testing when it meets the requirements of D.1.3 and D.1.4. It is also advisable to consider environmental factors and cleaning methods that affect the cleaning interval.

D. 1.2 The standard test kit should consist of bleached pure cotton fabric sheets. The size is approximately 900mmx1200mm, the warp yarn should be (30 ± 6) yarns/cm, the weft yarn should be (27 ± 5) yarns/cm, the mass per square meter should be (185 ± 5) g, and there should be no folding edges.

D. 1.3 Regardless of whether the cotton fabric is new or dirty, it should be cleaned and no fabric cleaning agents should be added.

Note: Fabric cleaning agents can affect the properties of fabrics and may contain volatile compounds that can cause the generation of non condensable gases.

D. 1.4 Cotton sheets should be dried and then placed in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60% for stable drying before use.

D. The 1.5 standard test package should be folded and assembled according to the provisions of Figure D.1:

D. 1.6 Cotton sheets should be folded into approximately 220mmx300mm, pressed by hand, and stacked to a height of approximately 250mm. Standard test bags should be wrapped with similar fabric and secured with tape with a width not exceeding 25m. The total weight of the standard test package should be (7 ± 0.14) kg (approximately 30 sheets of cloth are required). The standard test kit should be taken out of the sterilizer after the test cycle is completed and ventilated in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60% before continuing to be used. During each usage interval, the standard test kit should be stored in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60%. Note: After use, the standard test package will be compressed. If the quality of a 250mm thick standard test pack exceeds 7.14Kg, the standard test pack will no longer be used.

D. Before use, use calibrated instruments to measure the temperature and humidity of the standard test package. Ensure that the temperature inside the package is between 20 ℃ and 30 ℃, and the relative humidity is between 40% and 60%, otherwise it cannot be used for testing. D. The 1.8 test package can be made of different materials, with varying sizes and qualities, as long as it has the same effect as the standard test package,

D. 2 Small Scale Test Packages

D. 2.1 This test package is specifically designed for sterilizers with a loading capacity of no more than one sterilization unit. When the cycle parameters reach the set values and under specified conditions, steam can quickly and uniformly penetrate the test package.

The test kit can be used for BD testing, small load testing, fabric drying effect testing, and can also be combined with other materials to form a full load.

The test package can be reused and can be used for continuous testing when it meets the requirements of D.2.3 and D.2.4. Environmental factors and cleaning methods that affect the cleaning interval also need to be considered.

D. The fabric sheet used in the 2.2 test package should comply with the provisions of D.1.2 and be processed according to the methods specified in D.1.3, D.1.4, and D.1.5. D. 2.3 The fabric sheet should be stacked into approximately 220mmx300mm, and after being pressed by hand, it should be extended to a height of approximately 150mm. The test bag should be wrapped with similar fabric and secured with zip ties not exceeding 25mm in width. The total weight of the test package should be (4 ± 0.14) kg (approximately 17 fabric sheets are required). The test package should be taken out of the sterilizer after the test cycle is completed and ventilated in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60% before continuing to be used. During each usage interval, the test package should be stored in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60%. D. Before use, use calibrated instruments to measure the temperature and humidity of the test package. Ensure that the temperature inside the package is between 20 ℃ and 30 ℃, and the relative humidity is between 40% and 60%, otherwise it cannot be used for testing.

D. 3 standard biological testing kits

Note: The standard biological testing kit is used to test the killing effect of biological indicators.

D. 3.1 The standard biological testing kit can be reused and can also be used for continuous testing when it meets the requirements of D.3.3 and D.3.4. It is also necessary to consider the cleaning time interval and cleaning methods that affect environmental factors.

D. 3.2 The standard biological testing kit should consist of bleached pure cotton fabric, with dimensions of approximately 410mmx660mm.

D. 3.3 Regardless of whether the cotton fabric is new or dirty, it should be cleaned and no fabric cleaning agents should be added.

Note: Fabric cleaning agents can affect the properties of fabrics and may contain volatile compounds that can cause the generation of non condensable gases.

D. 3.4 Cotton sheets should be dried and then placed in an environment with a temperature of 20 ℃~30 ℃ and a relative humidity of 40%~60% for stable drying before use.

D. The 3.5 standard biological testing kit is made of 16 pieces of 410mmx660mm cotton cloth. Each fabric sheet is folded into 3 layers on the long side and 2 layers on the short side, and then stacked to create a standard biological testing kit with dimensions of approximately 230mmx230mmx150mm and a mass of (1.5 ± 0.14) kg.

D. 8 full load fabrics

D. 8.1 Test package simulates the maximum fabric mass that can be processed by the sterilizer, and tests that when the cycle parameters reach the set values, steam can quickly and evenly penetrate the fabric and achieve sterilization conditions.

D. 8.2 Full load fabrics can be reused and can be used for continuous testing when they meet the requirements of D.8.3 and D.8.4. It is also advisable to consider the cleaning time intervals and cleaning methods that affect environmental factors.

D. 8.3 The fully loaded fabric should consist of a folded cotton sheet and a standard test pack. The standard test pack specified in D.1 is suitable for sterilizers with a loading capacity exceeding one sterilization unit; the small-sized test pack specified in D.2 is suitable for sterilizers with a loading capacity not exceeding one sterilization unit; and the standard biological test pack specified in D.3 is used for killing tests of biological indicators.

D. 8.4 Each cotton sheet should contain at least 50% (by mass) of cotton fibers, with a mass of approximately 200g per square meter. Both new and dirty cotton sheets should be cleaned and no fabric cleaning agents should be added (see D1).

D. After drying the cotton fabric, it should be left to air dry for at least 1 hour in an environment with a temperature between 20 ℃ and 30 ℃ and a relative humidity of 40% to 60%.

D. After ventilation and drying, the fabric sheet should be folded into a bag. The mass of each package is (7.5 ± 0.6) kg.

D. 8.7 Standard test kits or standard biological test kits should be placed in the most difficult to sterilize location provided by the manufacturer. If there is no relevant information, the test package can be placed at the geometric center of the sterilization chamber's horizontal plane, approximately 100mm above the sterilization chamber's bottom horizontal plane. The remaining available space can be used to place other cotton bags in a sterilization basket similar in size to the standard sterilization unit (to prevent the cotton bags from falling off), filling the remaining available space in the sterilization room. If not applicable, the remaining space should be filled with a separate cotton cloth.

D. The fabric mass in each sterilization basket should be (7.5 ± 0.6) kg.

D. 9 Metal Testing Package

D. 9.1 This test package represents metal objects, such as instruments that are difficult to dry. The metal testing kit can be reused or continuously tested. D. 9.2 The sterilization load should include a test box with a stainless steel basket and a certain amount of metal screws wrapped in textile material. The test box should:

a) Seal the cover plate and comply with the provisions of Figure D.2;

b) Does not contain holes other than those shown in Figure D.2;

c) The structural material is 1mm thick stainless steel.

D. 9.3 Stainless steel baskets should:

a) Made of stainless steel;

b) The size of the bottom grid is 5mm x 5mm;

c) The size of the side grid is 5mm x 5mm;

d) The contact surface of the load is approximately 6mm away from the load-bearing support surface of the basket;

e) Capable of supporting an evenly distributed load of 10kg;

f) External dimensions: length (480 ± 5) mm, width 250mm~2541mm, height 50mm~55mm;

g) The mass is (1.3 ± 0.1) kg.

D. 9.4 The metal screws used for testing loads should:

a) The material is stainless steel;

b) The type is hexagonal head screw;

c) The total mass is (8.6 ± 0.1) kg;

d) Clean and dry, free from oil stains.

D. The fabric materials used in the 9.5 test should:

a) The test kit consists of a single piece of degreased pure cotton fabric. The size is approximately 900mmx1200mm, with warp yarn of (30 ± 6) count/cm and weft yarn of (27+5) count/cm;

b) Clean dirty cotton sheets without adding any fabric cleaning agents;

c) Perform drying and air drying treatment;

d) Store in an environment with a relative humidity of 40%~60% and a temperature of 20 ℃~30 ℃ for at least 1 hour.

Note: The above requirements are based on ensuring that the temperature and humidity of the packaged items are consistent with the local on-site environment before packaging.

D. All metal items in the 9.6 test package should reach temperature equilibrium at (23 ± 2) ℃.

D. The 9.7 test package should be assembled according to the following steps:

a) Place the stainless steel basket on the cloth sheet;

b) Place the screws evenly on the stainless steel basket;

c) Wrap the stainless steel basket with screws in a cloth sheet;

d) Put the wrapped stainless steel basket into the test box.

D. Before use, store the test package in an environment that meets the above conditions.

D. Process Challenge Device (PCD) for 10 cavity load test

D. The PCD for cavity load test 10.1 consists of a tube cover, connector, indicator holder, and hose, as shown in Figure D.3. Chemical indicators shall comply with the requirements of GB 18282.1, and the manufacturer shall provide the selection and usage methods of chemical indicators,

D. 10.2 The process challenge device meets the following requirements:

a) Material: Polytetrafluoroethylene (PTFE);

b) Tube wall thickness: (0.5 ± 0.025) mm;

c) Inner diameter of the tube: Medium (2.0 ± 0.1) mm;

d) Hose length: (1500 ± 15) mm;

e) Weight of indicator holder: (10.0 ± 0.1) g;

f) PCD internal free volume: (6 ± 1)% of the total internal volume of the device minus the volume of the indicator holder.

Note: Other materials that confirm equivalence are also applicable. When using other materials, the wall thickness and the quality of the indicator holder may change accordingly.

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