YY/T 1309-2016 English PDF

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YY/T 1309-2016: Washer-disinfectors. Requirement and test of ultrasonic wash
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Basic data

Standard ID: YY/T 1309-2016 (YY/T1309-2016)
Description (Translated English): Washer-disinfectors. Requirement and test of ultrasonic wash
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.10
Word Count Estimation: 8,881
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Quoted Standard: YY/T 0734.1; YY/T 0734.2
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard is applicable to cleaning and sterilizing machines with automatic ultrasonic cleaning function and in accordance with YY/T 0734.1, YY/T 0734.2, which specifies the special requirements for ultrasonic cleaning. This standard requires the use of the requirements specified in YY/T 0734.1, YY/T 0734.2.

YY/T 1309-2016: Washer-disinfectors. Requirement and test of ultrasonic wash

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Washer-disinfectors.Requirement and test of ultrasonic wash ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Cleaning disinfection ultrasonic cleaning requirements and testing 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Requirements 1 5 Test Method 2 Reference 5

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. Kunshan City ultrasound Instrument Co., Ltd., Lianyungang thousands of cherry Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Xu Hongquan, Feng Danqian, Zhu Lingyan, Liu Zhenjian, Ni Jingru. Cleaning disinfection ultrasonic cleaning requirements and testing

1 Scope

This standard is applicable to cleaning sterilizers with automatic ultrasonic cleaning function and in accordance with YY/T 0734.1, YY/T 0734.2. Set the special requirements for ultrasonic cleaning. This standard requires the use of the requirements specified in YY/T 0734.1, YY/T 0734.2.

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. YY/T 0734.1 Cleaning and disinfection Part 1. General requirements Term Definition and testing (YY/T 0734.1-2009, ISO 15883-1..2006, NEQ) YY/T 0734.2 Cleaning and disinfecting equipment - Part 2. Cleaning and disinfection requirements for heat and disinfection of surgical and anesthesia equipment And test (YY/T 0734.2-2009, ISO 15883-2..2006, NEQ)

3 terms and definitions

YY/T 0734.1, YY/T 0734.2 and the following terms and definitions apply to this document. 3.1 Ultrasonic cleaning ultrasonic wash Using ultrasonic waves in the water to produce cavitation effect of cleaning to remove the surface dirt and other impurities. 3.2 Ultrasonic cleaning chamber ultrasonic washchamber Used to place the load and load the parts for ultrasonic cleaning. 3.3 Ultrasonic generator ultrasonicpowersupply Means for generating a high frequency electrical oscillation signal. 3.4 Ultrasonic transducer ultrasonictransducer Means for converting electrical energy into mechanical energy and/or converting mechanical energy into electrical energy within the ultrasonic frequency range. 3.5 Ultrasonic media effective volume Ultrasonic level below the ultrasonic cleaning chamber volume.

4 requirements

4.1 Ultrasonic cleaning chamber 4.1.1 cavity should be no visible abnormal deformation phenomenon, the cavity surface should be smooth, no scratches. ......

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