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YY 1412-2016 English PDF

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US$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 1412-2016: Cardiopulmonary bypass systems. Centrifugal pump
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 1412-2016	199	Add to Cart	3 days	Cardiopulmonary bypass systems. Centrifugal pump	Valid

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Basic data

Standard ID: YY 1412-2016 (YY1412-2016)
Description (Translated English): Cardiopulmonary bypass systems. Centrifugal pump
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 10,166
Date of Issue: 2016-03-23
Date of Implementation: 2018-01-01
Quoted Standard: GB/T 191; GB 9706.1; GB/T 14710-2009; GB/T 9969; YY/T 0466.1; YY/T 1145
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 specifies the terms and definitions, classification, composition, parameters, requirements, test methods, marking, instructions for use, packaging, transport and storage of centrifugal pumps for cardiopulmonary bypass systems. This standard applies to cardiopulmonary bypass centrifugal pump (hereinafter referred to as centrifugal system). The centrifugal pump for medical units for operation and rescue, for cardiopulmonary bypass and extracorporeal membrane oxygenation in the blood perfusion or local perfusion, can be used independently and/or supporting the use of artificial heart-lung machine. This standard does not apply to: - Roller pumps; - Out-of-cycle piping; - Oxygenators; - Gas line filters; - Suction pumps; - Centrifugal pump heads.

YY 1412-2016: Cardiopulmonary bypass systems. Centrifugal pump

---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.
Cardiopulmonary bypass systems.Centrifugal pump ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Cardiopulmonary bypass system centrifugal pump 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this standard is mandatory. 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 is defined by the National Standard Committee on Medical Extracorporeal Circulation Equipment (SAC/TC158) and is responsible for the interpretation. The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Maike Wei (Shanghai) Medical Equipment Limited. The main drafters of this standard. Li Shi, Wang Ping, Fan Xiang, Li Aijun, Gu Xiaowei. Cardiopulmonary bypass system centrifugal pump

1 Scope

This standard specifies the terminology and definition, classification, composition, parameters, requirements, test methods, signs, and use of CPR centrifugal pumps. Brochures, packaging, transportation, storage. This standard applies to cardiopulmonary bypass system centrifugal pump (hereinafter referred to as centrifugal pump). The centrifugal pump for medical units for surgery and rescue, For cardiopulmonary bypass and extracorporeal membrane oxygenation surgery in the blood perfusion or local perfusion, can be used independently and/or supporting the use of artificial heart-lung machine. This standard does not apply. --- Roller pump; - extracorporeal circulation; --- Oxygenator; --- gas filter; Attract the pump --- centrifugal pump head.

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. GB/T 191 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 General rules for the use of industrial products GB/T 9969 Environmental requirements and test methods for medical appliances GB/T 14710-2009 YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements YY/T 1145 Artificial heart - lung machine terminology

3 terms and definitions

YY/T 1145 and the following terms and definitions apply to this document. 3.1 Centrifugal pump pump head centrifugalpump-head Centrifugal centrifugal force centrifugal force of the disposable perfusion device. 4 classification, composition, parameters 4.1 Classification 4.1.1 according to the different ways of blood flow are divided into. centrifugal constant flow, centrifugal pulsating. 4.1.2 According to the maximum speed is divided into. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 1412-2016_English be delivered?

Answer: Upon your order, we will start to translate YY 1412-2016_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 YY 1412-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY 1412-2016_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.