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YY 0790-2024 English PDF

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Upon your order, we will start to translate YY 0790-2024_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.

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Yes. The purchased PDF of YY 0790-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

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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). Avoidance of Double Taxation Agreements (DTAs) between Singapore and 100+ Countries: https://www.iras.gov.sg/taxes/international-tax

Q: Do you accept my currency other than USD?

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Q: Should I purchase the latest version YY 0790-2024?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0790-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0790-2024: Hemoperfusion equipment
Status: Valid

YY 0790: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0790-2024	279	Add to Cart	3 days	Hemoperfusion equipment	Valid
YY 0790-2010	349	Add to Cart	3 days	Hemoperfusion equipment

Similar standards

YY/T 0640 YY/T 0663.2 YY 0954 YY 0793.3 YY 0793.2

Basic data

Standard ID: YY 0790-2024 (YY0790-2024)
Description (Translated English): Hemoperfusion equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 14,154
Date of Issue: 2024-09-29
Date of Implementation: 2027-10-15
Older Standard (superseded by this standard): YY 0790-2010
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements for blood perfusion equipment and specifies the corresponding test methods. This standard applies to blood perfusion equipment defined in 3.1. This standard does not apply to: peritoneal dialysis equipment; centrifugal blood component separation equipment; continuous blood purification equipment; plasma exchange equipment; plasma adsorption equipment; hemodialysis equipment.

YY 0790-2024: Hemoperfusion equipment

---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.
ICS 11.040.40 CCSC45 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY 0790-2010 Hemoperfusion equipment Released on 2024-09-29 Implementation on October 15, 2027 The State Drug Administration issued

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 1 4.1 Normal working conditions of equipment 1 4.2 Flow Control 2 4.3 Temperature Control 2 4.4 Pressure Monitoring System 3 4.5 Preventing air injection 3 4.6 System Stability 3 4.7 Operating noise 3 4.8 Safety requirements 4 5 Test methods 4 5.1 Test working conditions 4 5.2 Flow control test 4 5.3 Temperature control test 5 5.4 Pressure monitoring system test 5 5.5 Air injection prevention test 6 5.6 System stability test 6 5.7 Working noise test 7 5.8 Safety requirements test 7

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY 0790-2010 "Hemoperfusion Equipment". Compared with YY 0790-2010, except for structural adjustments and editorial changes, In addition, the main technical changes are as follows. --- Changed "Scope" (see Chapter 1, Chapter 1 of the.2010 edition); --- Changed "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2010 edition); --- Changed "Normal working conditions of equipment" (see 4.1, 4.1 of the.2010 edition); --- Changed the requirements and test methods for "blood flow error" (see 4.2.1 and 5.2.1, 4.2.1 and 5.2.1 of the.2010 edition); --- Changed the requirements and test methods for "Control and protection of heparin pumps" (see 4.2.2 and 5.2.2, 4.2.2 and 5.2.2 of the.2010 edition) 5.2.2); --- Changed the requirements and test methods for "temperature control" (see 4.3 and 5.3, 4.3 and 5.3 of the.2010 edition); --- Changed the requirements and test methods for "pressure monitoring system" (see 4.4 and 5.4, 4.4 and 5.4 of the.2010 edition); --- Deleted the requirements and test methods for "mains power supply interruption" (see 4.5 and 5.5 of the.2010 edition); --- Changed the requirements and test methods for "prevention of air injection" (see 4.5 and 5.5, 4.6 and 5.6 of the.2010 edition); --- Changed the test method of "system stability" (see 5.6, 5.7 of the.2010 edition); --- Changed the test method for "operating noise" (see 5.7, 5.8 of the.2010 edition); --- Deleted the requirements and test methods for "appearance and structure" (see 4.9 and 5.9 of the.2010 edition); --- Changed the requirements and test methods of "Safety Requirements" (see 4.8 and 5.8, 4.10 and 5.10 of the.2010 edition); --- Deleted the requirements and test methods for "environmental testing" (see 4.11 and 5.11 of the.2010 edition); --- Deleted "Inspection rules" and "Marking, instruction manual, packaging, transportation and storage" (see Chapter 6 and Chapter 7 of the.2010 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). The previous versions of this document and the documents it replaces are as follows. ---First released in.2010 as YY 0790-2010; ---This is the first revision. Hemoperfusion equipment

1 Scope

This document specifies the requirements for hemoperfusion equipment and describes the corresponding test methods. This document applies to the hemoperfusion equipment defined in 3.1 (hereinafter referred to as equipment). This document does not apply to. ---Peritoneal dialysis equipment; ---Centrifugal blood component separation equipment; ---Continuous blood purification equipment; ---Plasma exchange equipment; ---Plasma adsorption equipment; ---Hemodialysis equipment.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance GB 9706.216 Medical electrical equipment Part 2-16.Basic safety of hemodialysis, hemodiafiltration and hemofiltration equipment and special requirements for basic performance YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility Requirements and tests YY 9706.108 Medical electrical equipment Part 1-8.General requirements for basic safety and essential performance Collateral standard. General requirements Requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems

3 Terms and definitions

The terms and definitions defined in GB 9706.216 and the following apply to this document. 3.1 It can draw the patient's blood out of the body to achieve blood perfusion, has the safety monitoring function required by this document, and can achieve blood transfusion equipment.

4 Requirements

4.1 Normal working conditions of equipment The normal operation of the equipment should meet the following conditions. a) Ambient temperature. 10℃~40℃ or as specified by the manufacturer; ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0790-2024_English be delivered?

Answer: Upon your order, we will start to translate YY 0790-2024_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 0790-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0790-2024_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.

Question 5: Should I purchase the latest version YY 0790-2024?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0790-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.