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YY/T 0215-2016: Ozone disinfector for medical purpose
Status: Valid YY/T 0215: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0215-2016 | English | 179 |
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3 days [Need to translate]
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Ozone disinfector for medical purpose
| Valid |
YY/T 0215-2016
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| YY 0215-2008 | English | 399 |
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3 days [Need to translate]
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Medical ozone disinfecting cabinets
| Obsolete |
YY 0215-2008
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| YY 0215.1-1995 | English | 399 |
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3 days [Need to translate]
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(Electric sterilizer safe disinfection general technical conditions)
| Obsolete |
YY 0215.1-1995
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PDF similar to YY/T 0215-2016
Standard similar to YY/T 0215-2016 YY/T 0802.1 YY/T 1268 YY 0451 YY/T 0802.2 Basic data | Standard ID | YY/T 0215-2016 (YY/T0215-2016) | | Description (Translated English) | Ozone disinfector for medical purpose | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Word Count Estimation | 9,922 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Older Standard (superseded by this standard) | YY 0215-2008 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0215-2016: Ozone disinfector for medical purpose---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.
Ozone disinfector for medical purpose
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0215-2008
Medical ozone disinfection equipment
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 specifications and classification 2
5 request 2
6 Test Method 3
7 logo, instruction manual 4
8 Packaging, transportation, storage 5
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0215-2008 "Medical Ozone Disinfection Cabinet".
This standard compared with YY 0215-2008, the main changes are as follows.
--- modified the standard name and scope of application;
--- increase the technical requirements of the ozone water equipment and electromagnetic compatibility requirements;
--- According to GB/T 14710 "medical electrical environment requirements and test methods" standard, modify the environmental test requirements;
- Appendix A and Appendix B were deleted.
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 unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Guangzhou City, Shun yuan medical equipment
Co., Ltd., Shenzhen City Zaidli Industrial Co., Ltd.
The main drafters of this standard. Gong Wanling, Hu Changming, Qiuwei Yu, Huang Xiulian, Li Yingshun, Huang Xiaojie.
This standard replaced the previous version of the standard release.
--- YY 0215.2-95;
--- YY 0215-2008.
Medical ozone disinfection equipment
1 Scope
This standard specifies the terminology and definitions, specifications and classification of medical ozone disinfection equipment, requirements, test methods, logos, instructions and
Packaging, transportation, storage.
This standard applies to medical ozone disinfection equipment (hereinafter referred to as disinfection equipment). The disinfection equipment uses ozone gas or ozone water to resist
Ozone-etched medical devices on the inner and/or outer surfaces of the medical device.
This standard does not apply to disinfection equipment (such as ultraviolet, chemical disinfectants, etc.) that may contain ozone other than ozone.
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 icon
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
General rules for the use of industrial products GB/T 9969
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
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
Disinfection technical specifications (the People's Republic of China Ministry of Health.2002 edition)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Ozone concentration ozoneconcentration
Disinfection equipment inside or output unit volume of gas or the amount of ozone contained in water, expressed in mg/m3 or mg/L.
3.2
Disinfection time
Disinfection equipment inside or the output of the ozone concentration maintained at the effective concentration of more than the duration.
3.3
No load empty-load
Disinfection equipment does not place the state of medical equipment.
3.4
Full load ful-load
Disinfection equipment according to the provisions of the manufacturer placed the maximum weight or volume of medical equipment status.
3.5
Amount of ozone leaked amountofozoneleak
Suspension equipment with full load or no load at rated voltage, maximum ozone in the air at 20 cm from its outer surface during the working cycle
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