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YY/T 1495-2016: Microbiological test method for demonstrating cleaning and disinfecting efficacy
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1495-2016 | English | 239 |
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Microbiological test method for demonstrating cleaning and disinfecting efficacy
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YY/T 1495-2016
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PDF similar to YY/T 1495-2016
Standard similar to YY/T 1495-2016 YY 1277 YY/T 1623 YY/T 1302.1 YY/T 1957 Basic data | Standard ID | YY/T 1495-2016 (YY/T1495-2016) | | Description (Translated English) | Microbiological test method for demonstrating cleaning and disinfecting efficacy | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Word Count Estimation | 12,140 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 65; GB 8599; YY/T 0646 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies a microbiological test method for verifying the effect of cleaning and disinfection. This standard applies to the surgical and anesthesia equipment and other medical equipment for hot and humid disinfection cleaning disinfection, does not apply to the use of chemical disinfection and disinfection of objects is not heat cleaning disinfection. | YY/T 1495-2016: Microbiological test method for demonstrating cleaning and disinfecting efficacy---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.
Microbiological test method for demonstrating cleaning and disinfecting efficacy
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Microbiological verification of cleaning and disinfection effects
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 Test material 1
5 test supplies 2
Preparation of test strain 3
7 Preparation of test contaminants 4
Preparation of Bacteria Carrier 4
9 verify the cleaning effect of cleaning 5
10 Results 5
Determination of Heat Tolerance of Enterococcus faecium
12 Biosecurity 6
Appendix A (informative) Media and reagents 7
Reference 9
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 drafting of this standard. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shandong Xinhua Medical Devices
Co., Ltd., Kunshan City ultrasound Instrument Co., Ltd., times of Man Medical Equipment (Shanghai) Co., Ltd.
The main drafters of this standard. Liu Yanhong, Hu Changming, Xu Weixiong, Qu Daoyin, Zhu Lingyan.
Microbiological verification of cleaning and disinfection effects
1 Scope
This standard specifies a microbiological test method for verifying the effect of cleaning and disinfection. And roundsys.s.s.s.s.s.s. ands.s.s. Finds.s.s. Finds.s.s. Finds.s.ithers.s.s. ands.s.
Equipment for heat and disinfection of the cleaning disinfection, does not apply to the use of chemical disinfection methods and disinfection of the object is not heat cleaning disinfection.
Note. YY/T 0734.1 and YY/T 0734.2 specify the requirements and methods for verifying the cleaning effect and disinfecting effect of the cleaning and sterilizer. This standard is provided
An alternative method of microbiological verification, but not the only way to verify the effect of cleaning and disinfecting. Other standards provided by the method if confirmed valid, also with the same
Applicable.
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 65 slotted cylindrical head screws
GB 8599 large steam sterilizer technical requirements automatic control type
YY/T 0646 small steam sterilizer automatic control type
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Standard strain typeculturestrain/referencestrain
Genes that are identified and guaranteed and traceable by genetic traits provided by domestic or foreign species preservation agencies.
3.2
Standard stockpile stockingculturestrain/referencestocks
A culture obtained by resuscitation of standard strains and growth in a suitable medium.
3.3
Working strain subculturestrain/workingcultures
The culture obtained by passage of the standard stockpile.
3.4
Bacteria carrier carrier susceptercoveredbytestmicroorganism
Inoculated with the support of the test microorganisms.
4 test materials
4.1 Bacterial carrier
--- stainless steel screws, specifications for the M6 × 20mm, should meet the requirements of GB/T 65;
--- rubber hose, diameter. (6 ± 1) mm, wall thickness. (2 ± 1) mm, no pyrogen, cold rolling.
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