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YY/T 0464-2019 English PDF

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Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0464-2019 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/T 0464-2019: Disposable hemoperfutor
Status: Valid

YY/T 0464: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0464-2019	279	Add to Cart	3 days	Disposable hemoperfutor	Valid
YY 0464-2009	479	Add to Cart	3 days	Disposable hemoperfutor	Obsolete
YY 0464-2003	519	Add to Cart	4 days	Single use hemoperfutor	Obsolete

Similar standards

YY/T 0640 YY/T 0663.2 YY/T 0606.9 YY 0267 YY 0465

Basic data

Standard ID: YY/T 0464-2019 (YY/T0464-2019)
Description (Translated English): Disposable hemoperfutor
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.30
Word Count Estimation: 14,155
Date of Issue: 2019
Date of Implementation: 2020-10-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the terms and definitions, classification and model nomenclature, requirements, test methods, signs and instructions, packaging, transportation and storage of single-use hemoperfusion devices. This standard applies to disposable blood perfusion devices (hereinafter referred to as perfusion devices) that use adsorbents such as activated carbon or adsorbent resin. and metabolites.

YY/T 0464-2019: Disposable hemoperfutor

---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.
Disposable hemoperfutor ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0464-2009 Disposable blood perfusion device Published on October 23,.2019 2020-10-01 implementation Published by the State Drug Administration

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Classification and model designation 1 5 Requirement 2 6 Test method 3 7 Signs and instructions 7 8 Packaging, transportation, storage 8 Appendix A (Normative Appendix) Method for Determining Particulate Content in Blood Perfusion Devices 9 References 11

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0464-2009 "Disposable blood perfusion device". Compared with YY 0464-2009, this standard Apart from the modifications, the main technical changes are as follows. --- Modified terms and definitions (see Chapter 3, Chapter 3 of the.2009 edition); --- Modified classification and naming (see Chapter 4, Chapter 4 of the.2009 edition); --- Increased the connection requirements of blood inlet and outlet ends and tubing (see 5.2); --- Increased the content of packed sorbent (see 5.3); --- Modified the test method for particle shedding (see Appendix A, Appendix A of the.2009 edition); --- Modified the chemical sample preparation method (see 6.6.1,.2009 version 6.4.1); --- Defined the sample preparation method of pyrogen test solution (see 6.9,.2009 version 6.5.3); --- Increased bacterial endotoxin content requirements (see 5.10); --- Increased the note on adsorption performance requirements (see 5.12,.2009 version 5.7); --- The sampling method for adsorption performance has increased the option of directly weighing the adsorbent after constant weight for selection (see 6.12.1,.2009 version 6.7.1); --- Increased the performance requirements for the validity period (see 5.14); --- Deleted the inspection rules (see Chapter 7 of the.2009 edition); --- Revised the requirements for signs and instructions (see Chapter 7, Chapter 8 of the.2009 edition); --- Revised storage requirements (see 8.3,.2009 version 9.3). Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Zhuhai Jianfan Biological Technology Co., Ltd. The main drafters of this standard. Ye Xiaoyan, He Xiaofan, Zhang Guanghai, Luo Jiewei, Du Hongyan, Cai Jianhua, Tian Ye. The previous versions of the standards replaced by this standard are. --- YY 0464-2003; --- YY 0464-2009. Disposable blood perfusion device

1 Scope

This standard specifies the terms and definitions, classification and model designation, requirements, test methods, signs and instructions of single-use blood perfusion devices. Books and packaging, transportation, storage. This standard applies to single-use blood perfusion devices (hereinafter referred to as perfusion devices) that use adsorbents such as activated carbon or adsorption resin. The device cooperates with a blood purification device for blood perfusion, and removes endogenous and exogenous drugs, poisons and metabolites from the patient's body.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, storage and transportation pictograms (GB/T 191-2008, ISO 780..1997, MOD) GB/T 13074 blood purification term (GB/T 13074-2009) GB/T 14233.1-2008 Test methods for medical infusions, blood transfusions and syringes-Part 1. Chemical analysis GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- (2011, ISO 10993-1..2009, IDT) GB/T 16886.4 Biological evaluation of medical devices. Part 4. Selection of tests for interaction with blood (GB/T 16886.4- 2003, ISO 10993-4..2002, IDT) GB/T 16886.5 Biological evaluation of medical devices Part 5. In vitro cytotoxicity test (GB/T 16886.5-2017, (ISO 10993-5..2009, IDT) GB/T 16886.10 Biological evaluation of medical devices Part 10. Irritation and skin sensitization test (GB/T 16886.10-2017, (ISO 10993-10..2010, IDT) GB/T 16886.11 Biological evaluation of medical devices Part 11. Systemic toxicity test (GB/T 16886.11-2011, (ISO 10993-11..2006, IDT) Pharmacopoeia of the People's Republic of China (2015 Edition)

3 terms and definitions

The terms and definitions defined in GB/T 13074 apply to this document.

4 Classification and model designation

4.1 Classification The perfusion device can be divided into two types. activated carbon type and resin type. 4.2 Model designation Perfuser specifications are named after adsorbent volume (mL). ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0464-2019_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0464-2019_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/T 0464-2019_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0464-2019_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/T 0464-2019?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0464-2019 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.