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Washer-disinfectors - Part 5: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices
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YY/T 0734.5-2020
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Basic data Standard ID | YY/T 0734.5-2020 (YY/T0734.5-2020) | Description (Translated English) | Washer-disinfectors - Part 5: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C47 | Classification of International Standard | 11.080.10 | Word Count Estimation | 22,271 | Date of Issue | 2020 | Date of Implementation | 2021-01-01 | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies the special requirements and test methods for washer-disinfectors for chemical disinfection of non-intrusive medical devices that are not resistant to high temperatures. The requirements of this standard are used in combination with the general requirements specified in YY/T 0734.1-2018. The washer-disinfectors required by this standard are applicable to non-invasive, non-high temperature reusable medical devices, special requirements for cleaning and chemical disinfection in one cycle, including performance requirements for cleaning and disinfection, and Component and accessory requirements may apply. The requirements of this standard do not apply to the washer-disinfectors defined in the scope of YY/T 0734.2, YY/T 0734.3, YY/T 0734.4 and GB/T 35267. |
YY/T 0734.5-2020: Washer-disinfectors - Part 5: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices ---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.
Washer-disinfectors--Part 5. Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Cleaning and sterilizer part 5. for high temperature
Non-intrusive medical devices for chemical disinfection
Requirements and test of washer-disinfector
(ISO 15883-7..2016, Washer-disinfectors-Part 7. Requirementsandtestsfor
2020-02-21 release 2021-01-01 implementation
Issued by the State Drug Administration
Foreword
YY/T 0734 "Cleaning and Disinfector" is divided into the following 5 parts.
--- Part 1. General requirements and tests;
--- Part 2. Requirements and tests for the washer-disinfector for disinfection of surgical and anesthesia instruments, etc.
--- Part 3. Requirements and tests for the washer-disinfector for sterilization of human waste containers by heat and humidity;
--- Part 4. Requirements and tests of washer-disinfectors for non-intrusive medical devices such as moist heat disinfection;
--- Part 5. Requirements and tests for chemical disinfection of non-intrusive medical devices that do not withstand high temperatures.
This part is Part 5 of YY/T 0734.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the redrafting method to modify the use of ISO 15883-7..2016 "for non-invasive, non-critical, high temperature medical devices and protection
Requirements and tests for cleaning and disinfecting equipment using chemical disinfection for health equipment ".
Compared with ISO 15883-7..2016, this part has more structural adjustments.Appendix A lists this part and ISO 15883-7.
A comparison list of.2016 article numbers.
Compared with ISO 15883-7..2016, there are technical differences between this part and the clauses involved in these differences have been passed on the outer margin
The placed vertical single line (|) is marked. Appendix B gives a list of corresponding technical differences and their causes.
This section also made the following editorial changes.
--- Modified the standard name;
--- Removed Appendix A of ISO 15883-7..2016.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200).
This section was drafted by. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Weigao Group
Tuan Medical Polymer Products Co., Ltd.
The main drafters of this section. Chen Kun, Xing Liyong, Sun Mingqiang, Hong Zixiang, Wang Yi.
Cleaning and sterilizer part 5. for high temperature
Non-intrusive medical devices for chemical disinfection
Requirements and test of washer-disinfector
1 Scope
This part of YY/T 0734 stipulates the special cleaning and sterilizer for chemical disinfection of non-intrusive medical devices that are not resistant to high temperatures
Requirements and test methods.
Note. These medical devices are usually low-risk medical devices, such as hospital beds, operating tables, wheelchairs, etc.
The requirements of this part are combined with the general requirements specified in YY/T 0734.1-2018.
The washer-disinfector required in this part is suitable for non-interventional, high temperature resistant reusable medical devices, which can be cleaned in a cycle
Special requirements for cleaning and disinfection of cleaning and chemical disinfection, including performance requirements for cleaning and disinfection, as well as possible use of components and accessories
Requirements.
The requirements of this part do not apply to the definitions in the scope of YY/T 0734.2, YY/T 0734.3, YY/T 0734.4 and GB/T 35267
Clean the sterilizer.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Part 1. General Requirements (GB 4793.1-2007,
(IEC 61010-1..2001, IDT)
GB/T 18268.1 Requirements for electromagnetic compatibility of electrical equipment for measurement, control, and laboratory use. Part 1. General requirements
(GB/T 18268.1-2010, IEC 61326-1..2005, IDT)
GB/T.19973.1 Sterile microbiological methods for medical devices Part 1. Determination of the total number of microorganisms on products
(GB/T.19973.1-2015, ISO 11737-1..2006, IDT)
GB/T 35267 Endoscope washer-disinfector (GB/T 35267-2017, ISO 15883-4..2008, NEQ)
YY/T 0734.1-2018 Washer-disinfector part 1. General requirements and tests (ISO 15883-1..2006 AMD1.
2014, MOD)
YY/T 0734.4 Cleaning and sterilizing device Part 4. The cleaning and sterilizing device for non-intrusive medical equipment such as moist heat disinfection
Summation test (YY/T 0734.4-2016, ISO 15883-6..2011, NEQ)
3 Terms and definitions
The terms and definitions defined in YY/T 0734.1-2018, YY/T 0734.4 and GB/T 35267 and the following apply to this document.
3.1
Chemical disinfection
Disinfection achieved through the action of one or more disinfectants.
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