YY/T 1309-2016Washer-disinfectors-Requirement and test of ultrasonic wash (English PDF)
清洗消毒器超声清洗的要求和试验
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 1309-2016 is the English-translated version of 清洗消毒器超声清洗的要求和试验.
YY/T 1309-2016 is the Chinese pharmaceutical industry standard that sets the particular requirements for washer-disinfectors with an automatic ultrasonic cleaning function, applying together with YY/T 0734.1 and YY/T 0734.2.
It covers the ultrasonic frequency and power and their distribution in the tank, the degassing of the water, the cleaning performance obtained with ultrasound and the checks that confirm it. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1309-2016
National Standard of the People's Republic of China
- ICS
- 11.080.10
- Classification
- C 47
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 Requirements
- 5 Test Method
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
Means for generating a high frequency electrical oscillation signal.
3.4 Ultrasonic transducer
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
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Related Standards
YY/T 0734.1-2009 — Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
YY/T 0734.1-2018 — Washer-disinfectors - Part 1: General requirements and tests
YY/T 0734.2-2009 — Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, etc.
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YY/T 1309-2016
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