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YY/T 0215-2016 English PDF

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YY/T 0215-2016: Ozone disinfector for medical purpose
Status: Valid

YY/T 0215: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0215-2016English179 Add to Cart 3 days [Need to translate] Ozone disinfector for medical purpose Valid YY/T 0215-2016
YY 0215-2008English399 Add to Cart 3 days [Need to translate] Medical ozone disinfecting cabinets Obsolete YY 0215-2008
YY 0215.1-1995English399 Add to Cart 3 days [Need to translate] (Electric sterilizer safe disinfection general technical conditions) Obsolete YY 0215.1-1995

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Older Standard (superseded by this standard) YY 0215-2008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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