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YY/T 1687-2019: Disinfector employing hot water
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1687-2019 | English | 239 |
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Disinfector employing hot water
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YY/T 1687-2019
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Basic data | Standard ID | YY/T 1687-2019 (YY/T1687-2019) | | Description (Translated English) | Disinfector employing hot water | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.10 | | Word Count Estimation | 12,124 | | Date of Issue | 2019 | | Date of Implementation | 2020-10-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, classification, requirements, test methods, nameplates, outer packaging and instructions for use, packaging, transportation and storage of boiling sterilizers used in medical institutions. This standard applies to equipment that sterilizes cleaned medical devices immersed in water by heating the water in a non-hermetic container to a set temperature. This standard does not apply to boiling disinfection products in the laundry or catering industry. | YY/T 1687-2019: Disinfector employing hot water---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.
Disinfector employing hot water
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Boiling sterilizer
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Contents
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification 1
5 Requirement 1
6 Test method 4
7 Nameplate, outer packaging and instruction manual 6
8 Packaging, transportation and storage 7
Appendix A (Normative Appendix) Microbial Disinfection Effect Test 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Disinfection Technology and Equipment (SAC/TC200).
This standard was drafted. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Kunshan Ultrasound Instrument
Co., Ltd.
The main drafters of this standard. Robin A, Lin Manting, Yu Xizi, Liu Heng, Zhu Lingyan.
Boiling sterilizer
1 Scope
This standard specifies the terms and definitions, classification, requirements, test methods, nameplates, packaging and use of boiling sterilizers for medical institutions.
Instruction manual, packaging, transportation and storage.
This standard applies to the cleaning of medical equipment immersed in water by heating the water in a non-closed container to a set temperature.
Poisonous equipment.
This standard does not apply to boiling disinfection products in the laundry or catering industry.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1. General requirements
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Requirements for electromagnetic compatibility of electrical equipment for measurement, control and laboratory use. Part 1. General requirements
3 terms and definitions
The following terms and definitions apply to this document.
3.1
A device for disinfecting medical equipment after immersion using hot water heated to 65 ° C ~ 100 ° C.
3.2
A0 value
Equivalent time measured in seconds at 80 ° C in damp heat disinfection, taking z value as 10 ° C.
3.3
Holding time
The time that key process variables remain at or above the specified value.
4 Classification
The classification of boiling sterilizers is as follows.
a) According to different heating methods, it is divided into electric heating type boiling sterilizer and steam heating type boiling sterilizer;
b) According to different door opening methods, it is divided into manual door-type boiling sterilizer and automatic door-type boiling sterilizer.
5 Requirements
5.1 Normal working conditions
Normal working conditions should meet the following requirements.
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