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YY/T 1463-2016: Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1463-2016 | English | 139 |
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Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites
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Basic data | Standard ID | YY/T 1463-2016 (YY/T1463-2016) | | Description (Translated English) | Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 7,755 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB 18279.1-2015; GB 18281.1-2015 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to medical device manufacturers for sterilization confirmation tests, and not for routine sterilization tests. This standard does not apply to microbiological challenges or contamination processes in the confirmation or disinfection of medical device cleaning effects. | YY/T 1463-2016: Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites
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Sterilization validation of medical device.Guidance on selecting a microbial challenge and inoculation sites
ICS 11.080.01
C47
People's Republic of China Pharmaceutical Industry Standard
Sterilization of medical devices
Selection of microbiological challenges and guidelines for bacteria
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 standard drafting unit. Guangzhou Yang Pu Medical Technology Co., Ltd., Taier Mao Medical Products (Hangzhou) Co., Ltd., Shi Jie medical technology
(Shanghai) Co., Ltd., Nanjing minimally invasive Medical Technology Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality supervision and inspection
center.
The main drafters of this standard. Xu Honglei, Weng Hui, Xu Xinggang, Xu Haiying, Miao Xiaolin, Zhou Zhilong.
Sterilization of medical devices
Selection of microbiological challenges and guidelines for bacteria
1 Scope
This standard selects the appropriate microbiological challenge for the sterilization confirmation process, the appropriate site of the bacteria, the method of infection, and the recovery of the bacteria
Of the technology to provide the appropriate guide.
This standard applies to medical device manufacturers for sterilization confirmation tests, and not for routine sterilization tests.
This standard does not apply to microbiological challenges or contamination processes in the confirmation or disinfection of medical device cleaning effects.
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 18279.1-2015 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and identification of sterilization processes for medical devices
Conventional control requirements
Health care products - Sterilization - Biological indicators - Part 1. General rules GB 18281.1-2015
3 terms and definitions
GB 18279.1 and GB 18281.1 and the following terms and definitions apply to this document.
3.1
Biological indicator
A specific test system for a specific sterilization process.
3.2
Bacterial vector inoculatedcarrier
A specific number of viable test microorganisms are contained on or in a particular material.
3.3
Stained liquid
Suspension suspension
Contains the liquid of the surviving test microorganism.
Note. Normally, the two phrases of the bacterial suspension and the stained bacteria can be used.
3.4
Substrate Substrate
Microbial challenge process, the product or carrier contact with the bacterial suspension site.
4 Microbiological Challenge Types and Selection Criteria
4.1 When selecting specific microbes and bacteria for microbiological challenges, consider the following principles.
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