YY/T 0679: Evolution and historical versions
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| YY/T 0679-2025 | English | RFQ |
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(Steam formaldehyde sterilizer)
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YY/T 0679-2025
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| YY/T 0679-2016 | English | 699 |
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Low temperature steam and formaldehyde sterilizers for medical purposes
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YY/T 0679-2016
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| YY 0679-2008 | English | RFQ |
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Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers
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YY 0679-2008
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Basic data | Standard ID | YY/T 0679-2025 (YY/T0679-2025) | | Description (Translated English) | (Steam formaldehyde sterilizer) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.10 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2027-01-01 | | Older Standard (superseded by this standard) | YY/T 0679-2016 | | Issuing agency(ies) | National Medical Products Administration | YY/T 0679-2016: Low temperature steam and formaldehyde sterilizers for medical purposes---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.
Low temperature steam and formaldehyde sterilizers for medical purposes
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0679-2008
Medical low temperature steam formaldehyde sterilizer
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 type and mark 3
5 requirements 4
6 Test methods 13
7 logo and instructions 15
8 Packaging, transportation, storage 16
Appendix A (Normative Appendix) Test Method 17
Appendix B (Normative Appendix) Test Plan 21
Appendix C (Normative Appendix) Test Equipment
Appendix D (Normative Appendix) Test the desorption performance using a filter paper indicator
Appendix E (informative) Test methods for formaldehyde residues on medical devices
Appendix F (informative) Impact of formaldehyde on the environment
Reference 31
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0679-2008 "medical low temperature steam formaldehyde sterilizer", compared with YY 0679-2008, the main changes are as follows.
- the removal of the requirements of the inspection rules;
--- The contents of the normative reference document have been modified, and the IEC 61010-2-040..2005 standard supersedes the IEC 61010-2-042 standard.
This update the normative reference file;
--- in the normal working conditions 4.3.1f) to increase the "drainage system" requirements, more comprehensive norms of the normal working conditions of the sterilizer;
--- "Test cycle" in 5.1.2 "Door and interlock of sterilization chamber" to "Test or repair operation cycle";
--- in 5.3.4.5 "0kPa to sterilization pressure within the range of accuracy should be ≤ 0.4kPa" modified to "0kPa to sterilization pressure range
The accuracy should be ≤ 0.8kPa ";
--- in 5.3.4.7f) "at 0kPa to sterilization pressure accuracy should be ≤ 0.4kPa" modified to "0kPa to sterilization pressure accuracy
Should be ≤ 0.8kPa ";
- the individual sample sample residue limit of "250 μg" at 5.6 "desorption availability" was modified to "400 μg", and it was found that
Sterilization chamber or test package in the random distribution of condensate, may lead to test the residual value of formaldehyde when the difference is relatively large, so according to
EN14180..2003 A2..2009 Revision of limits;
- In the 5.11 "Environmental Test Requirements", the "Supplementary Provisions on Environmental Tests in Table 1" is amended to read as follows. "Environmental tests according to the technical requirements of the product
Supplemented by the provisions of ", according to the different products, test time, recovery time and testing items may be different, should be based on
Enterprise requirements of the environment to request, so this modification;
- Added "average sound pressure level" requirement in 5.8 "noise"
- the table "sterilization performance test content" in the original inspection rule is placed after the contents of Appendix B test plan.
This standard refers to EN14180..2003 A2..2009 "medical disinfection sterilization low temperature steam formaldehyde sterilizer requirements and testing"
(Sterilizersformedicalpurposes-Lowtemperaturesteamandformaldehydesterilizers-Requirementsand
testing, and EN14180..2003 A2..2009 degree of consistency is not equivalent.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized.
The drafting of this standard. Zhangjiagang Valin Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices Co., Ltd., the national food and drug
Supervision Authority Guangzhou Medical Device Quality Supervision and Inspection Center, times of Man Medical Equipment (Shanghai) Co., Ltd.
The main drafters of this standard. Huang Hongxin, Qiuwei Yu, Zhou Jianfang, Xu Weixiong, Zhang Haijun, Gong Wanling.
This standard replaced the previous version of the standard release.
--- YY 0679-2008.
Medical low temperature steam formaldehyde sterilizer
1 Scope
This standard specifies the terminology and definition of medical low temperature steam formaldehyde sterilizer (hereinafter referred to as sterilizer), type and marking, requirements, test
Methods, signs and instructions, packaging, transportation, storage.
The sterilizers specified in this standard mainly use low temperature steam and formaldehyde mixed gas to sterilize the heat-resistant medical items.
This standard does not involve the validation of formaldehyde sterilization process and the daily quality control requirements, but the test method in this standard
And equipment can be used for verification and routine control of sterilizers.
This standard does not specify safety requirements for the use of the risk range.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 Packaging and Storage Icons (GB/T 191-2008, ISO 780..1997, MOD)
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (GB 4793.1-2007,
IEC 61010-1..2001, IDT)
Environmental requirements and test methods for medical appliances GB/T
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
(GB/T 18268.1-2010, IEC 61326-1..2005, IDT)
GB 18281.1 Sterilization of biological products for health care products - Part 1. General principles (GB 18281.1-2015, ISO 11138.
2006, IDT)
GB 18281.5 Sterilization products for health care products - Part 5. Biological indicators for low temperature steam formaldehyde sterilization
(GB 18281.5-2015, ISO 11138-5..2006, IDT)
GB/T 19633 Packaging of the final sterilized medical device (GB/T 19633-2005, ISO 11607..2003, IDT)
YY/T 0883 Vapor Penetration Test Procedure Challenge Device and Indicator System (YY/T 0883-2013, EN867-5..2001,
NEQ)
IEC 61010-2-040..2005 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040. Procedures for the treatment of medical equipment
With the special requirements of sterilizers and sterilizers for materials (Safetyrequirementsforelectricalequipmentformeasurement,
controlandlaboratoryuse-Part 2-040. Particularrequirementsforsterilizersandwasher-disinfectors
usedtotreatmedicalmaterials)
EN60584-2 Thermocouple Part 2. Tolerances (Thermocouples-Part 2. Tolerances)
EN60751 Industrial Platinum Resistance Temperature Sensors (Industrialplatinumresistancethermometersandplatinum
temperaturesensors
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Permission control tool accessdevice
Only by the authorized person to use the key, password or tool.
3.2
Ventilation aeration
One or more parts of the sterilization process under which the formaldehyde and its reaction product are desorbed from the sterilization load to a predetermined level
Of the process, these processes can be carried out in the sterilizer, but also in a single cabinet room.
3.3
To handle
The sterilized articles are treated prior to the maintenance time of the sterilization cycle so that all sterilization loads reach a predetermined temperature and humidity
process.
3.4
Cycle variable cyclevariables
Refers to physical parameters, such as temperature, pressure and concentration of the sterilant, which can affect the effect of the sterilization cycle.
3.5
Desorption desorption
After the contact time period is completed, the sterilant is removed from the sterilization chamber and the sterilized product.
3.6
Balance time equilibrationtime
The reference point reaches the sterilization temperature and the sterilization load reaches the time interval between the sterilization temperatures.
3.7
Exposure time
From the sterilization chamber into the sterilization chamber to the time interval between the beginning of the desorption.
3.8
Hold time holdingtime
In the sterilization chamber, the temperature, pressure and steam formaldehyde concentration remain within the preset range.
Note. After the balance time is to maintain the time.
3.9
Sterilization solution microbicidalsolution
Formaldehyde aqueous solution for producing a sterilizing agent in a sterilizer.
3.10
Manual intervention
Due to maintenance or other safety reasons, it is necessary to make a procedure to interrupt or change the procedure.
3.11
Cycle late ventilated rinse post-cycleflushing
At the stage after the "cycle is complete", the sterilized loading remains in the closed sterilization chamber and the sterilized chamber is completed
exchange.
3.12
Process Challenge Device PCDprocesschalengedevice
The device for the specific resistance to the sterilization process is used to evaluate the effectiveness of the sterilization process.
3.13
Reference measurement points
The position of the temperature sensor used to control the sterilization cycle.
3.14
Sterilant
A sterile medium formed by steam and gaseous formaldehyde.
3.15
Sterilant injection into sterilantinjection
The sterilant is injected into the vacuum sterilization chamber once or more times until the set pressure is reached.
3.16
Sterilization cycle
In the sterilizer to achieve the purpose of sterilization and desorption automatically carried out the whole process.
3.17
Sterilization temperature
Can achieve the minimum temperature of sterilization effect.
3.18
Sterilization temperature range sterilizationtemperatureband
The temperature range allowed for sterilization of all points in the room during the maintenance period is the minimum sterilization temperature.
3.19
The theoretical temperature of the sterilant theoreticalsterilanttemperature
The temperature calculated from the relationship between the temperature of the sterilant and the vapor pressure.
3.20
Effective space usablespace
Sterilization chamber can effectively place the sterile load space.
Note. The effective space is expressed by the width, height and depth of the sterilization chamber.
3.21
Confirm validation
This is a documented program that allows you to obtain, record and describe the test data, indicating that the sterilization process always
Set the standard.
4 type and mark
Type 4.1
The sterilizer type is as follows.
a) The sterilizer is divided into steam generator and external steam according to steam supply.
b) Sterilizer according to the structure of the door can be divided into single or double door.
4.2 markings
For the effective space of the sterilization chamber, the following expression can be used, the size in mm as a unit.
a) the cylindrical sterilization chamber is shown in the effective space. diameter × height or diameter × length;
b) The expression of the effective space in the box body is. width × height × depth or length × width × height;
c) The representation of other shapes of effective space is described by a method similar to a) or b).
4.3 normal working conditions
4.3.1 The normal operation of the sterilizer should meet the following conditions.
a) Ambient temperature. 5 ° C to 40 ° C;
b) relative humidity. not more than 85%;
c) atmospheric pressure. 70kPa ~ 106kPa;
d) use power. ac220V ± 22V, 50Hz ± 1Hz or ac380V ± 38V, 50Hz ± 1Hz;
e) Sterilizer sterilization temperature. 50 ℃ ~ 80 ℃ range optional;
f) The steam, water, compressed air, drainage system and ventilation system used in the sterilizer shall be provided in accordance with the manufacturer's instructions.
4.3.2 The sterilant should meet the following requirements.
a) prepare a sterilant solution according to the manufacturer's instructions for use and produce a sterilant after evaporation;
NOTE. The presence of liquid formaldehyde and/or paraformaldehyde in the sterilization chamber may affect the effectiveness and safety of the process.
b) the composition and concentration of the sterilant should meet the standards of the manufacturer of the sterilizer;
c) The sterilant should be stabilized (eg with ethanol) to prevent polymerization;
d) Containers of sterilizers stored in sterilizers shall comply with the standards of the manufacturer of the sterilizer;
e) If the sterilizer requires other reagents in addition to the sterilant, it shall be ensured that no reaction will occur between them;
f) The storage requirements and shelf life of the sterilant should be stated on the container.
5 request
5.1 sterilization chamber
5.1.1 Material of sterilization chamber
The sterilization chamber in contact with the sterilant and its accessories and the supporting system for the articles to be sterilized should be made of corrosion resistant material. The material should not be sterilized
And should not release any known substances that are toxic to human health and the environment.
5.1.2 Door and interlock of sterilization chamber
5.1.2.1 Sterilizers are divided into single or double door structures.
5.1.2.2 After the door of the sterilization chamber is closed, the artificial intervention should be carried out without opening the sterilization cycle.
5.1.2.3 The door of the sterilizer should not be opened during the sterilization cycle.
5.1.2.4 If the sterilization cycle is accidentally interrupted (eg due to a malfunction), a password or tool should be required to open the door of the sterilizer.
5.1.2.5 Door seals should be easy to clean and replace.
5.1.2.6 For a two-door sterilizer, the unloading door should not be opened until the indication of the end of the sterilization cycle does not occur.
5.1.2.7 For the operating cycle for testing or maintenance, the indication of "cycle complete" shall be in such a way as to indicate the end of the normal sterilization cycle
with. For a two-door sterilizer, the door on the unloading side should not be opened after the test cycle has been completed.
5.1.2.8 The device for controlling the start of the sterilization cycle shall be installed on the loading side of the sterilizer.
5.1.2.9 For a two-door sterilizer, the two doors should be interlocked and, in addition to maintenance requirements, two doors should not be opened at the same time.
5.1.2.10 For a two-door sterilizer, both sides shall be provided with means for indicating whether or not the side door can be opened.
5.1.2.11 After the door is opened, the indication of "cycle complete" shall disappear. For a two-door sterilizer, the unloading door opens, closes and locks the process again
, The loading door should remain locked.
5.1.3 Heat sterilization chamber
The sterilization chamber surface should be heated to the preset temperature before the sterilization cycle can begin.
5.1.4 Test the connection port
5.1.4.1 The sterilization chamber shall have a test connection port to connect the pressure measuring device. This connection should be in a convenient location, but not
In the sterile media pipeline or discharge line, the connection should be marked on the pressure test (pressuretest, PT) cap, and effective sealing.
see picture 1.
The unit is in millimeters
a Pipe thread dimensions see GB/T 7307.
Note. The dimensions in the figure are examples only.
Figure 1 Example of connection between a pressure test device and a sterilization chamber
5.1.4.2 The sterilization chamber shall have a direct temperature test connection, which shall be located in a convenient location and shall be marked with a temperature test
(temperaturetest, TT) cap, and effectively sealed. See Figure 2.
The unit is in millimeters
a Pipe thread dimensions see GB/T 7307.
Note. The dimensions in the figure are examples only.
Figure 2 Example of temperature entry connection
5.2 Design and structure
5.2.1 Piping and related accessories
5.2.1.1 Pipes and associated accessories that may be in contact with the sterilant shall not be affected by the sterilant under the specified operating conditions. Material should be
Can not release any known toxic substances.
NOTE. In order to avoid heat loss or condensation, all media lines may be insulated from the insulation unless the function of the sterilizer is likely to be affected.
5.2.1.2 All water and steam inlet and outlet connections shall be fitted with a filter to prevent entry of impurities that affect the operation of the sterilizer.
5.2.1.3 Piping shall be designed to prevent the accumulation of condensate.
5.2.1.4 All control valves in the piping shall be marked with a permanent mark according to their function.
5.2.2 Emissions systems
5.2.2.1 The sterilizer shall have a discharge system for the discharge of air, water vapor and formaldehyde. When the sterilizer uses a vacuum system, the manufacturer should state
The system meets the minimum pressure required for performance testing.
5.2.2.2 The sterilizer shall have a leak test function. Leakage test, the pressure rise rate shall not exceed 0.1kPa/min.
5.2.3 Ventilation system
5.2.3.1 The sterilization chamber shall be ventilated after the sterilization stage is completed. When the desorption and pressure balance is completed, the sterilized articles should be re-contaminated.
5.2.3.2 Air filtration equipment should be easily replaced. In the pressure difference of 100kPa and maximum air flow conditions, the filter device filtration efficiency
The rate should be ≥99.5% (particle diameter > 0.3μm). Appropriate means should be made to ensure that the liquid does not flow back from the sterilization chamber to the filter unit.
5.2.4 Rack and side panels
5.2.4.1 Sterilizer In addition to the installation in the wall or partition design in the installation of the way, the side should be covered with side panels.
5.2.4.2 The material of the side plate shall be resistant to corrosion or have a corrosion-resistant protective layer on its surface. Ventilation shall be provided on the side plate.
5.2.4.3 The side plates on the sterilizer should be easy to disassemble and facilitate maintenance.
5.3 display, measurement, operation and recording device
5.3.1 General requirements
5.3.1.1 The instrument of the sterilizer shall be located where the operator is easy to observe and shall be able to distinguish it according to their function.
5.3.1.2 These devices shall be properly secured and protected to ensure that they are functioning properly during the operation of the sterilizer.
5.3.1.3 When the display device is connected to multiple sensors, all monitored signals should be displayed in turn.
5.3.1.4 In the minimum ambient lighting (215 ± 15) lx, the meter reading should be easily read out from the meter (1 ± 0.15) m.
5.3.1.5 indicates that the measuring and recording device shall be capable of being adjusted in a simple manner or apparatus without any disassembly.
5.3.1.6 Other functions attached to the recording and display devices shall not affect the accuracy of recording or display.
5.3.2 temperature measurement device
5.3.2.1 When the temperature measurement device for process control, monitoring or data recording, 20 ℃ ~ 100 ℃ range of accuracy should be ≤ 1 ℃; in the measurement off
Bacteria temperature should be ≤ 0.5 ℃.
5.3.2.2 It should be ensured that the temperature control system can only be operated by a rights control tool.
5.3.2.3 At least two independent sensors should be used to display, control and record the temperature of the sterilization chamber. The sensor should be placed in sterilization
Indoor manufacturers that the most representative of the sterilization temperature of the location of space, here is the reference measurement point.
5.3.2.4 The recording and control devices shall be independent of each other and shall be connected in any of the ways shown in Fig.
5.3.2.5 When the sensor fails, the temperature control system should be faulty.
5.3.3 Temperature display device
The temperature display device shall meet the requirements of 5.3.2.1 and the following.
a) the temperature should be expressed in degrees Celsius;
b) The display range should include 0 ° C to 100 ° C;
c) the minimum scale value of the analog device should be ≤ 2 ℃;
d) digital device resolution should be ≤ 0.1 ℃.
5.3.4 Pressure measurement and display devices
5.3.4.1 When the pressure measurement and display system is used for control, monitoring or recording, it shall be ensured that only the use of the rights control tool is required to operate.
5.3.4.2 Absolute pressure measurement systems shall be used when process control, monitoring or recording is to be carried out.
5.3.4.3 When measuring sterilization chamber pressure, use at least two separate sensors for display, control and recording.
5.3.4.4 Control and recording devices shall be independent of each other and shall be connected in any of the ways shown in Fig.
5.3.4.5 When performing process control, monitoring or recording of readings, the accuracy of the pressure measurement and display device shall not be greater than 0.5% of the measuring range,
In the 0kPa to sterilization pressure range of the accuracy should be ≤ 0.8kPa.
Description.
1 --- sterilization chamber;
--- temperature device;
--- pressure device;
--- temperature recorder;
--- pressure recorder;
---Temperature Controller;
---pressure controller.
Figure 3 Connection of temperature and pressure sensors
5.3.4.6 When the process is controlled, monitored or recorded, if the sensor fails, the pressure measurement system shall have a fault indi...
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