Path:
Home >
MISC >
Page348 > WS/T 649-2019
Price & Delivery
US$349.00 · In stock · Download in 9 secondsWS/T 649-2019: Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See
step-by-step procedureStatus: Valid
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| WS/T 649-2019 | English | 349 |
Add to Cart
|
4 days [Need to translate]
|
Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
|
Click to Preview a similar PDF
Basic data
| Standard ID | WS/T 649-2019 (WS/T649-2019) |
| Description (Translated English) | Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Classification of International Standard | 11.080 |
| Word Count Estimation | 15,116 |
| Date of Issue | 2019 |
| Date of Implementation | 2019-07-01 |
| Issuing agency(ies) | National Health Commission |
WS/T 649-2019: Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Hygienic requirement for medical purpose-low temperature steam and formaldehyde sterilizers
ICS 11.080
C 50
WS
People's Republic of China Health Industry Standard
Medical cryogenic steam formaldehyde sterilizer hygiene requirements
Hygienic requirement for medical purpose-low temperature steam and formaldehyde
Sterilizers
Published on.2019 - 01 - 30
2019 - 07 - 01 implementation
National Health and Wellness Committee of the People's Republic of China
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1.
This standard is mainly drafted by. Shandong Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health-related Product Safety
Institute, Shandong Mental Health Center, Jiangsu Provincial Center for Disease Control and Prevention, Shanghai Disinfection Products Association, Heilongjiang Provincial Center for Disease Control and Prevention.
The main drafters of this standard. Cui Shuyu, Yang Bin, Zhang Liubo, Dong Fei, Chen Yu, Li Zikai, Liu Lei, Zhang Jian, Li Yan, Wang Yuyan,
Zhao Keyi, Wen Xianqin, Meng Wei, Sun Qihua, Xu Yan, Xue Guangbo, Lin Ling, Zhang Enzhong, Yang Jing, Wang Qichen, Xie Caro, Zou Yihua.
Medical cryogenic steam formaldehyde sterilizer hygiene requirements
1 Scope
This standard specifies the type and marking of medical low temperature steam formaldehyde sterilizer, technical requirements, inspection methods, precautions for use, and standards.
Know the requirements.
This standard applies to low temperature steam formaldehyde sterilizers that use formaldehyde for sterilization of medical devices under low temperature conditions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB/T 19633 final sterilization medical device packaging
GBZ 2.1 Occupational exposure limits for workplace hazards Part 1. Chemically harmful factors
GBZ 2.2 Occupational exposure limits for workplace hazards Part 1. Physical factors
GBZ/T 159 Collection of monitoring of hazardous substances in the workplace air
GBZ/T 189.8 Physical measurement of workplaces - Part 8. Noise
GBZ/T 300.99 Determination of toxic substances in the workplace - Part 99. Formaldehyde, acetaldehyde and butyraldehyde
Sterilization of health care products - Biological indicators - Part 5. Biological indicators for
EN 14180 Medical Disinfector Low Temperature Steam Formaldehyde Sterilizer Requirements and Testing
EN 867-5 Indicator systems and treatment equipment for the performance testing of non-biological systems, class B and class S mini sterilizers
specification
EN 60584-2 Thermocouples Part 2. Tolerances
EN 60751 Industrial Platinum Resistance Thermometer Sensor
Management Specification for Labeling Instructions for Disinfecting Products (2005) Ministry of Health (Wei Jian Fa [2005] No. 426)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Low temperature steam and formaldehyde sterilization
When the temperature is lower than 85 ° C, after forced air is discharged, steam formaldehyde is injected under negative pressure, and the articles to be sterilized are exposed to steam formaldehyde.
Sterilization is maintained for a certain period of time in a stable state.
3.2
Cycle variables
Parameters that affect the effectiveness of the sterilization cycle, including temperature, pressure, time, and sterilant concentration.
3.3
Sterilization temperature
The minimum sterilization temperature set by the sterilizer.
3.4
Sterilization temperature band
The temperature range allowed for each point in the chamber during sterilization maintenance time.
3.5
Reference measuring point
The temperature and pressure sensor position used to control the sterilization cycle.
3.6
Equilibrium time
The time interval between the reference measurement point and the sterilization load at each measurement point is the sterilization temperature.
3.7
Exposure time
The time interval during which the sterilant is injected into the sterilization chamber to the beginning of desorption.
3.8
Sterilization holding time
In the sterilization chamber, the temperature, pressure, and vapor formaldehyde concentration are maintained within a preset range.
3.9
Effective volume usable space
The volume of the sterilization load can be effectively placed in the sterilization chamber.
3.10
Ventilation aeration
One or more parts of the sterilization process, desorbing formaldehyde and its reaction products from a sterilization load to a predetermined level under specific conditions
the process of.
3.11
Desorption desorption
The process of removing sterilant from the sterilization chamber and load after the end of the exposure time.
3.12
Sterilization semi-cycle sterilization semi-cycle
The sterilization maintenance time is half of the set value, and the other period variables are unchanged.
3.13
Process challenge device
A device that constitutes a specific resistance for evaluating the effectiveness of the sterilization process.
4 type and marking
4.1 Type of sterilizer
4.1.1 The sterilizer is divided into its own steam generation type and external steam type according to the steam supply mode.
4.1.2 Sterilizers are classified by door and can be divided into single door and double door.
4.2 Marking
The sterilization chamber space of the sterilizer can be expressed in the following way, the length is in mm.
a) cylindrical sterilization chamber representation method. diameter × length;
b) Rectangular sterilization chamber representation. length × width × height;
c) Other shape sterilization chamber representation methods. described in a manner similar to a) or b).
5 Technical requirements
5.1 sterilizer material requirements
The sterilization chamber in contact with the sterilizing agent and its accessories and the support system for the articles to be sterilized shall be made of corrosion-resistant materials. Material is not subject to sterilant
The impact should not release substances that are toxic to human health and the environment.
5.2 Sterilization procedures
The complete sterilization process is in accordance with EN 14180, as shown in Figure 1.
Figure 1 The whole process of low temperature steam formaldehyde sterilization
Note. 1 ╌ sterilization cycle begins; a ╌ sterilization process;
2 ╌ sterilizing agent injection begins; b ╌ working cycle;
3╌ rinse; c╌ sterilization cycle;
4╌ sterilization cycle completion indication; d╌ exposure time;
5 post-cycle period; e╌ balance time;
6╌ Delayed opening/unloading cycle completion indication; f╌ Preheating;
7 ╌ Sterilized items are removed (if ventilation is required outside the sterilizer); ɡ╌ Exhaust air and inject formaldehyde;
8 ╌ atmospheric pressure. i ╌ desorption;
J╌ ventilation.
5.3 Performance requirements
5.3.1 Temperature
5.3.1.1 The temperature in the sterilization chamber shall comply with the regulations of the manufacturer, the lower limit of the sterilization temperature range is the sterilization temperature, and the upper limit is the sterilization temperature.
4 ° C.
5.3.1.2 The temperature shall not exceed the upper limit of the sterilization temperature range throughout the sterilization cycle.
5.3.1.3 The balance time should not exceed 60 s before entering the maintenance time.
5.3.1.4 The temperature specified in the sterilization maintenance time shall be within the sterilization temperature range, and the difference between each point shall not exceed 2 °C.
5.3.1.5 The sterilization maintenance time should not be lower than the set value of the manufacturer and should not exceed 10% of the set value.
5.3.2 Pressure
5.3.2.1 Pressure curve
Obtained by measuring the sterilization cycle pressure, including the pressure range, the measurement interval, and the rate of pressure change during the partial sterilization phase.
The measurement results should meet the requirements of the manufacturer.
5.3.2.2 Pressure curve requirements
The pressure requirements are as follows.
a) The complete pressure curve and associated pressure limits should be displayed throughout the sterilization cycle;
b) The maximum rate of change of pressure should not exceed 1000 kPa/min, and the measurement interval is 3 s;
c) During the sterilization maintenance time, the pressure curve should be within the pressure range specified by the manufacturer.
5.3.3 Sterilization performance
The biological indicators exposed to the sterilization half cycle are all inactivated.
5.4 Special material requirements
5.4.1 sterilizing agent
5.4.1.1 The composition and concentration of the sterilizing agent shall be in accordance with the value indicated by the manufacturer.
5.4.1.2 The upper and lower limits of the sterilant labeling amount shall not exceed 10%, and the analysis is pure. The stability is not less than 12 months.
5.4.1.3 The sterilizing agent should be prepared according to the instruction manual; if the sterilizing agent is changed, the effectiveness and safety evaluation should be re-examined.
5.4.1.4 Stabilizers should be added to prevent polymerization.
5.4.1.5 The packaging of the sterilizing agent should be in good condition to ensure that the outer packaging can effectively protect the product and avoid damage during transportation, handling and other processes.
5.4.1.6 The packaging container of the sterilizing agent shall be matched with the sterilizer interface, and the marking shall comply with the “Management Specification for the Labeling of Disinfection Products”.
5.4.2 Analytical water requirements
The analytical water should be sterile and comply with the relevant regulations of the purified water of the Pharmacopoeia of the People's Republic of China.
5.4.3 Ventilation requirements
5.4.3.1 When the sterilization cycle requires air to be introduced into the sterilization chamber, the air needs to be filtered and entered, and should be clean and sterile.
5.4.3.2 The filter device should be made of materials resistant to corrosion and degradation and should be easily replaced.
5.4.3.3 The filtration device should have a filtration efficiency of ≥99.5% for particles with a diameter of 0.3 μm or more under a pressure difference of 100 kPa and maximum airflow.
5.4.3.4 Appropriate means shall be used to ensure that liquid is not returned to the filter unit by the sterilization chamber.
5.5 Security
5.5.1 Requirements for formaldehyde concentration in the air of the workplace
The concentration of formaldehyde in the workplace air should meet the requirements of GBZ 2.1.
5.5.2 Requirements for formaldehyde residues on sterilized articles
Using a filter paper with a diameter of 70 mm as a carrier, after a sterilization procedure, the amount of formaldehyde adsorbed on the filter paper was used to evaluate the inside of the formaldehyde sterilizer and the sterilized material.
Residue of formaldehyde on the product. For filter paper with a diameter of 70mm, the average value of the same batch of sterilized carrier shall not exceed.200 μg/piece, the maximum value
Must not be larger than 400 μg/piece. For filter papers with a diameter different from 70 mm, the residual limit should be adjusted in proportion to the change in surface area.
5.5.3 Electrical safety
Electrical safety performance should meet the requirements of GB 4793.1.
5.5.4 Noise
The sterilizer shall not have abnormal noise during operation, and its noise shall comply with the requirements of GBZ 2.2.
6 Test methods
New installation, overhaul, update sterilization method or change procedure, sterilization load or loading method, etc., or according to relevant national requirements,
The following tests should be performed.
6.1 Temperature and pressure detection
Perform temperature and pressure tests in accordance with Appendix A.
6.2 Sterilization performance test
Test according to Appendix B.
6.3 Security Testing
6.3.1 Determination of formaldehyde concentration in the air of the workplace
Sampling and testing according to GBZ/T 159 and GBZ/T 300.99. Sampling at a distance of 20 cm from the sterilizer, it is necessary to test the sterilizer during operation and
The concentration of formaldehyde at the time of opening the door after the sterilization process.
6.3.2 Analysis with validity test
Follow Appendix C.
6.3.3 Electrical safety testing
Conduct electrical safety testing in accordance with GB 4793.1.
6.3.4 Noise detection
When the sterilizer is operating normally, its noise is measured in accordance with GBZ/T 189.8.
7 Precautions for use
7.1 Medical cryogenic vapor formaldehyde sterilizers should be placed in relatively independent rooms that are dry, ventilated, and free from corrosive gases.
7.2 The working environment temperature should be between 5 °C and 40 °C, and the relative humidity should not exceed 85%.
7.3 The sterilized items should be properly cleaned and dried before sterilization.
7.4 The packaging material shall be made of materials that do not absorb or decompose formaldehyde and pass the verification.
7.5 should contain instructions for the correct loading of the item.
7.6 Pay attention to personal protection during operation.
7.7 The sterilizer shall contain alarm devices and physical parameter monitoring devices for the sterilization process.
8 Identification requirements
8.1 Packaging Mark
The mark used for packaging shall comply with the requirements of GB/T 191.
8.2 Labels and instructions
Labels and instructions shall comply with the relevant provisions of the “Regulations on the Management of Labels for Disinfecting Products” (2005).
AA
Appendix A
(normative appendix)
Physical property detection method
A.1 Overview
The physical properties of the sterilization cycle should be tested on the same machine under no-load, small load and full load conditions, continuous test 3
Times, all qualified.
A.2 Test load
A.2.1 Small load
A.2.1.1 Overview
Select a small load to test the normal operation of the low temperature steam formaldehyde sterilization cycle. Small load consists of multiple sets of small samples, sterilization chamber volume
When increasing, the number of samples increases accordingly. A sterilization chamber with an effective volume of less than 100 L is placed with 1 small load sample unit per 10 L effective volume.
A sterilization chamber with an effective volume greater than 100 L, with an additional 25 L effective capacity in addition to the 10 small load sample units used for a volume of 100 L
Add one small load sample unit.
A.2.1.2 Small load sample unit
The small load sample unit consists of three process challenge devices (PCD), and the process challenge device (PCD) should comply with EN 867-5 requirements.
Packed in double-layer paper according to GB/T 19633.
A.2.2 Full load
A.2.2.1 Overview
Select full load to reflect the large load in the low temperature steam formaldehyde sterilization cycle. At least the maximum load weight specified by the manufacturer should be used
90% of the test load. The full load consists of a full load cell and other samples. Full load unit accounts for at least 15% of the maximum load weight, other
The sample consists of articles and materials similar to the full load unit, and the weight of the load attachment is not included in the load weight.
A.2.2.2 Full load unit
The full load unit should consist of the following materials.
a) 1500 mm long PVC pipe with an inner diameter of 4 mm and an outer diameter of 6 mm. The tube is double-layered and has a total weight of 40 g ± 5 g;
b) 1000 mm long PVC pipe with an inner diameter of 8 mm and an outer diameter of 12 mm, embedded in a PVC pipe with a M8×60 stainless steel screw
End. Full tube double-layer packaging, total weight 120 g ± l0 g;
c) Rod of polyamide PA11 or PA12, length 80 mm, diameter 15 mm, 1 M8 x 60 stainless steel screw, polyamide rod and no
Stainless steel screws are double-layered, with a total weight of 45 g ± 5 g;
d) 1 stainless steel tube with a length of 230 mm, an inner diameter of 6 mm and an outer diameter of 8 mm. Stainless steel tube is double-layered, with a total weight of 45 g ± 5 g;
e) PCD device, double package.
Transparent plastic/paper composite bags for packaging shall comply with the provisions of GB/T 19633. The total weight of the full load unit is 250 g ± 25 g, excluding
Sample loading accessories.
A.3 Test equipment
A.3.1 Material requirements
Temperature and pressure testing equipment must have high temperature resistance, moisture resistance, pressure resistance, chemical corrosion resistance, etc., and its overall sealing waterproofness
can.
A.3.2 Pressure test equipment
A.3.2.1 Equipment for testing pressure is the device used to verify pressure indication and recording. A pressure compensation system should be used.
A.3.2.2 The pressure test equipment used shall have a verification/calibration certificate within the validity period.
A.3.2.3 The pressure measurement range should be between 0.1KPa and 400KPa; the pressure display resolution is 0.01KPa; the time recording interval can be accurate to 1s.
A.3.3 Temperature test equipment
A.3.3.1 Temperature sensor The application of a platinum resistor in accordance with Class A of EN 60751 or a thermocouple in accordance with tolerance class 1 of EN 60584-2.
A.3.3.2 The temperature sensor shall have a verification/calibration certificate within the validity period.
A.3.3.3 The temperature measurement range should be between 0 °C and 150 °C, the temperature measurement accuracy is ±0.1 °C, and the temperature display resolution is 0.01 °C.
Recording interval can be accurate to 1s.
A.4 Temperature and pressure detection methods
A.4.1 Temperature and pressure test under no-load conditions
A.4.1.1 The purpose of the test is mainly to prove that the temperature and pressure conditions under no-load conditions meet the set requirements and determine the entire sterilization cycle.
The key position such as the highest temperature in the middle.
A.4.1.2 For sterilizers with a sterilization chamber volume of less than 1000 L, at least 10 temperature sensors are placed, on which the volume is increased.
One 100 L is added, and the sensor is placed in a representative position on the inner surface of the sterilizer; at least one pressure test instrument is placed.
A.4.1.3 Perform the measurement according to the instructions for using the sterilizer to run the sterilization procedure.
A.4.2 Small load temperature and pressure test
A.4.2.1 The purpose of the test is mainly to prove that the temperature and pressure conditions in the sterilization load meet the set requirements. Second, prove that the entire sterilization
During the cycle, the rate of pressure change is maintained within a certain range, without destroying the packaging of the sample and sample; determining the location with the lowest temperature;
A.4.2.2 Place the small load unit in the effective volume of the sterilization chamber;
A.4.2.3 For sterilizers with a sterilization chamber volume of less than 60 L, place at least 4 temperature sensors, 60 L to 100 L sterilizers, at least
Place 6 temperature sensors, sterilizers larger than 100 L, and add 2 temperature sensors for each 100 L increase in volume. Reference test
Place one temperature sensor on the measuring point and place the other temperature sensors on average in the available space with the loaded sample. Note that those have
Determined key locations; place at least 2 pressure testers to ensure that there is a pressure tester in the chamber space and in the load cell package.
A.4.2.4 Run the sterilization procedure according to the instruction manual. Ensure that the test equipment and recording equipment can record the entire process.
A.4.3 Full load temperature and pressure test
A.4.3.1 The purpose of the test is to demonstrate that the temperature and pressure conditions in the sterilization load meet the set requirements;
A.4.3.2 Place the full load unit in the available space in the sterilization chamber;
A.4.3.3 The temperature and pressure sensor requirements are the same as A.4.2;
A.4.3.4 Place a temperature sensor at the reference measurement point. Unpack and place 2 temperature sensors into the package described in A.2.2.2 b)
And c), tape the temperature sensor and the screws in the wrapping paper to maintain good contact, seal the double-layer packaging and put it back to full load.
In the unit. Place the full load cell in a known location in the available space, which proves to be the lowest temperature location in the small load temperature test.
Place the remaining sensors on average in the available space;
A.4.3.5 Run the sterilization procedure according to the instruction manual. Ensure that the test equipment can record the entire process.
BB
Appendix B
(normative appendix)
Sterilization performance test method
B.1 Overview
When the physical parameters such as temperature and pressure meet the requirements of this standard, the microbial sterilization effect is confirmed, respectively, at small load and full load.
Under the condition, the sterilization half cycle is to be completed, and the biological indicators should be completely inactivated after the sterilization half cycle is completed. This experiment is repeated 5 times, all qualified, verified
Sterilization performance of the sterilizer.
B.2 Testing microbial carrier preparation
B.2.1 Geobacillus stearothermophilus ATCC 7953 or SSIK 31 may be certified
Microorganisms with resistance to IS0 11138-5. The D60 value of Bacillus stearothermophilus spores should be ≥6.0 min. Other microorganisms should
When there is a D value that meets the conditions of use.
B.2.2 Carrier selection.
a) metal sheet. 15 mm diameter stainless steel disc;
b) glass piece. 10 mm × 10 mm glass piece;
c) Plastic sheet. 10 mm × 10 mm PTFE plastic sheet;
d) Consideration should be given to the more complex design of medical devices, which are consistent with the daily sterilization load.
B.2.3 Carrier recovery amount. 1 × 106 cfu/piece ~ 5 × 106 cfu/piece.
B.2.4 Place the carrier in the PCD, the PCD is packaged in double layers; for the carrier that cannot be placed in the PCD, it is packaged in sterilized packaging material and placed in small
Load unit and full load unit. Sterilized packaging materials should meet the requirements of GB/T 19633.
B.3 Detection method
B.3.1 The number of indicators depends on the size of the sterilization space and should be able to accurately assess the effectiveness of the sterilization process. Sterilization under small load conditions
a sterilizer with a chamber volume of less than 60 liters, at least 7 microbial carriers; 60 liters to 100 liters of sterilizers, at least 11 microbial carriers;
A sterilizer larger than 100 L, on the basis of which a microbial carrier is added for every 100 L increase in volume. The microbial carrier at full load should be at least full
The quantity is required under small load conditions, and each full load unit has at least one microbial carrier. Small load and full load conditions are the same as A.2.1 and
A.2.2.
B.3.2 Place the double-packaged PCD on average in the available space of the sterilization room and record the distribution.
B.3.3 After the end of the half-pass sterilization cycle, the product microbial carrier (biological indicator) shall be cultured in accordance with the conditions specified by the manufacturer.
To raise, the self-made Bacillus stearothermophilus spore carrier was transferred to bromocresol purple protein broth and cultured at 56 ° C for 7 days, and all should be grown aseptically.
CC
Appendix C
(normative appendix)
Desorption efficiency test
C.1 Principle
Determine by standard spectrophotometer, calculate how many μg (micrograms) of formaldehyde in each filter paper to achieve
The formaldehyde and paraformaldehyde residues in the bacteria were pre-tested for the purpose of evaluation, and the experiment was repeated 3 times, all of which were qualified.
C.2 Test materials
Considering that the porous materials such as textiles and papers have strong absorption and retention of formaldehyde and paraformaldehyde, filter paper with a diameter of 70 mm is selected.
For the carrier of the sterilizer desorption test, the filter paper should meet the requirements of Table C.1.
Table C.1 Filter paper char...
...
