YY/T 0734.4-2016 English PDF

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YY/T 0734.4-2016: Washer-disinfectors. Part 4: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0734.4-2016	139	Add to Cart	3 days	Washer-disinfectors. Part 4: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.	Valid

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Basic data

Standard ID: YY/T 0734.4-2016 (YY/T0734.4-2016)
Description (Translated English): Washer-disinfectors. Part 4: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.10
Word Count Estimation: 7,798
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: YY/T 0734.1-2009; YY/T 0734.2; YY/T 0734.3; ISO/TS 15883-5
Adopted Standard: ISO 15883-6-2011, NEQ
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the special requirements for cleaning and disinfecting non-intrusive medical devices such as damp heat disinfection. This type of cleaning and sterilizer ensures that the level of sterilization is maintained by cleaning and hygienic sterilization (A0 is not less than 60). At the same time, automatic recording of key process parameters during the cleaning process does not require an independent recording system. This standard requires the use of the general requirements specified in YY/T 0734.1-2009. The cleaning disinfectants required by this standard are suitable for the cleaning and disinfection of medical devices such as non-invasive (ie, non-penetrating skin or non-contact mucosal surfaces). The requirements of this standard do not apply to the cleaning sterilizer defined in the range YY/T 0734.2, YY/T 0734.3, nor are it applicable to endoscopic cleaning sterilizers,

YY/T 0734.4-2016: Washer-disinfectors. Part 4: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.

---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.
Washer-disinfectors.Part 4. Requirements and tests for washer-disinfectors employed thermal disinfection for non-invasive medical devices, etc. ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Clean the sterilizer Part 4. Conducting non - intrusive medical devices Damp heat disinfection cleaning and disinfection requirements and testing Washer-disinfectors-Part 4. Requirementsandtestsforwasher-disinfectors Organizationthermaldisinfectionfornon-invasivemedicaldevices, etc. (ISO 15883-6..2011, Washer-disinfectors-Part 6. Requirementsandtestsfor non-criticalmedicaldevicesandhealthcareequipment, NEQ) 2016-01-26 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 methods 3 6 logo and instructions 3 7 Packaging, transportation, storage 4

Foreword

YY/T 0734 "cleaning sterilizer" is divided into five parts. - Part 1. General requirements, terms and tests; - Part 2. Requirements and tests for cleaning and disinfecting of heat and heat disinfection of surgical and anesthesia equipment; - Part 3. Requirements and tests for cleaning and disinfection of waste heat disinfectants for human waste containers; - Part 4. Requirements and tests for cleaning and disinfection of non - intrusive medical devices for damp heat disinfection; - Part 5. Requirements and tests for cleaning and disinfecting chemical disinfection of medical devices such as non-invasive and non-invasive medical devices. This section is part 4 of YY/T 0734. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section is the same as ISO 15883-6..2011 "Cleaning Sterilizer Part 6. For non-intrusive, non-critical medical devices and medical equipment Line wet heat disinfection of the cleaning and disinfection requirements and test "(English version) of the consistency is not equivalent. The main differences between this section and ISO 15883-6..2011 are. --- adjust the standard structure; - Added the contents of Chapters 6 and 7 of this section and supplemented some of the test methods; --- Deleted terms with Part 2 (such as cleaning temperature, cleaning temperature range, etc.) and so on; --- Appendix A relating to inspection rules is deleted. 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 section is proposed by the State Food and Drug Administration. This part of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized. This part of the drafting unit. Shandong Xinhua Medical Devices Co., Ltd., Lianyungang 1000 cherry Medical Equipment Co., Ltd., the national food and drug Supervision and Administration Director Guangzhou Medical Device Quality Supervision and Inspection Center, Kunshan City ultrasound Instrument Co., Ltd. The main drafters of this part. Huang Xiulian, Wang Hongmin, Qu Daoyin, Liu Zhenjian. Clean the sterilizer Part 4. Conducting non - intrusive medical devices Damp heat disinfection cleaning and disinfection requirements and testing

1 Scope

This part of YY/T 0734 specifies the special requirements for cleaning and disinfecting non-intrusive and other medical devices. this Class cleaning sterilizers ensure that the level of disinfection is maintained by cleaning and moist heat sterilization (A0 value is not less than 60). At the same time, the cleaning process is critical Automatic recording of process parameters does not require a separate recording system. This part requires the use of the general requirements specified in YY/T 0734.1-2009. This part of the required cleaning disinfection for non-invasive (ie, non-penetrating skin or non-contact mucosal surface) and other medical devices Cleaning and disinfection. The requirements of this section do not apply to cleaning sterols as defined in the range YY/T 0734.2, YY/T 0734.3, nor are they applicable to endoscopes Cleaning and disinfection, the medical equipment specified in this section does not include power equipment, luminal instruments and other interventional devices. NOTE. Damp heat disinfection of the load can be achieved by hot water rinsing, exposure to steam or a combination of both.

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. Cleaning and disinfecting - Part 1. General requirements, Terminology definitions and tests - YY/T 0734.1-2009 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 0734.3 Cleaning and disinfecting equipment - Part 3. Cleaning and disinfecting requirements for hygienic disinfection of human waste containers test ISO /T S15883-5 Cleaning and disinfecting - Part 5. Test contaminants and test methods for the verification of cleaning effects (Washer-disin- fectors-Part 5. Testsoilsandmethodsfordemonstratingcleaningefficacy)

3 terms and definitions

YY/T 0734.1 Definitions and the following terms and definitions apply to this document. 3.1 Non-invasive instruments non-invasivedevice Through the human body cavity or body surface, can not penetrate the body of the device.

4 requirements

4.1 Overview 4.1.1 shall comply with the requirements of YY/T 0734.1-2009, except that 4.4.2,4.7,4.13,4.15 in YY/T 0734.1-2009 shall not apply ......

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