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GB/T 35267-2017 English PDF

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US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 35267-2017: Endoscopes washer-disinfectors
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 35267-2017	279	Add to Cart	3 days	Endoscopes washer-disinfectors	Valid

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Basic data

Standard ID: GB/T 35267-2017 (GB/T35267-2017)
Description (Translated English): Endoscopes washer-disinfectors
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.10
Word Count Estimation: 14,142
Date of Issue: 2017-12-29
Date of Implementation: 2019-07-01
Regulation (derived from): National Standards Bulletin 2017 No. 32
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB/T 35267-2017: Endoscopes washer-disinfectors

---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.
Endoscopes washer-disinfectors ICS 11.080.10 C47 National Standards of People's Republic of China Endoscopic cleaning and disinfection (ISO 15883-4.2008, Washer-disinfectors-Part 4.Requirementsandtests thermo-labileendoscopes, NEQ) 2017-12-29 Posted 2019-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafted law reference ISO 15883-4.2008 "cleaning and disinfecting part 4. The heat endoscopy for chemical consumption Toxic cleaning disinfection requirements and test "(English version) prepared, and ISO 15883-4.2008 consistency is not equivalent. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection and equipment (SAC/TC200) centralized. This standard drafting unit. Shandong Xinhua Medical Devices Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision Inspection Center. The main drafters of this standard. Han Bingguang, Wang Hongmin, Li Shining, Hu Changming, Lu Zhong, Wang Peijing. Endoscopic cleaning and disinfection

1 Scope

This standard specifies the terms and definitions, requirements, test methods and signs of soft endoscopic cleaning and disinfection (hereinafter referred to as cleaning and disinfection) Instructions for use, packaging, transportation, storage. This standard applies to the soft endoscope automatically cleaning, disinfection cleaning and disinfection. This standard does not apply to endoscopic cleaning, sterilization process validation and daily quality control requirements, nor does it apply to the scope of the use of risk Safety assessment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. Endoscopic automatic cleaning and disinfection machine hygiene requirements YY/T 0734.1-2009 Cleaner and sterilizer - Part 1. General requirements, definitions of terms and tests Disinfection technical specifications Ministry of Health.2002 edition The People's Republic of China Pharmacopoeia (three).2015 edition

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Endoscope wash sterilizer endoscopewasher-disinfector Automated equipment for the cleaning and disinfection of soft endoscopes using chemical disinfection methods. 3.2 Leak test leaktest Confirm the integrity of the endoscopic and endoscopic tubes inside the unbroken test, test to maintain a low positive pressure. 3.3 Self-disinfectionprocedure Operating procedures under the control of an automatic controller, used when the washer cavity is empty, for use on cleaning, disinfecting and rinsing instruments All liquid delivery systems, chambers, sinks and other components in contact with water and aqueous solutions are sterilized. 3.4 z value In a damp heat sterilization process, the change rate of the microorganism inactivation rate ten times change in degrees Celsius (° C). 3.5 A0 value A0Value At 80 ℃ wet heat disinfection in seconds equivalent time, take z value of 10 ℃.

4 structure and working conditions

4.1 Structure Cleaning and disinfection should at least include doors, piping systems, testing systems, control systems and display systems. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 35267-2017_English be delivered?

Answer: Upon your order, we will start to translate GB/T 35267-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 35267-2017_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 35267-2017_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.