|
US$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0485-2020: Single-use cardioplegia delivery system
Status: Valid YY 0485: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0485-2020 | English | 189 |
Add to Cart
|
3 days [Need to translate]
|
Single-use cardioplegia delivery system
| Valid |
YY 0485-2020
|
| YY 0485-2011 | English | 359 |
Add to Cart
|
3 days [Need to translate]
|
Single-used cardioplegia delivery system
| Obsolete |
YY 0485-2011
|
| YY 0485-2004 | English | 319 |
Add to Cart
|
3 days [Need to translate]
|
Single use cardioplegia delivery system
| Obsolete |
YY 0485-2004
|
PDF similar to YY 0485-2020
Basic data | Standard ID | YY 0485-2020 (YY0485-2020) | | Description (Translated English) | Single-use cardioplegia delivery system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,116 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-12-01 | | Issuing agency(ies) | State Drug Administration | YY 0485-2020: Single-use cardioplegia delivery system---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.
Single-use cardioplegia delivery system
ICS 11.040.20
C45
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0485-2011
Cardioplegia perfusion device for single use
2020-06-30 released
2021-12-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0485-2011 "Disposable Cardioplegia Perfusion Device", compared with YY 0485-2011, except for editorial
The main technical changes are as follows.
---Added the requirements of pump pipe performance (see 4.2.1);
---Modified the requirements for the flow rate of the perfusion device (see 4.2.1.1, 4.2.6 of the.2011 edition);
---Modified the requirements of variable temperature performance (see 4.2.3, 4.2.3 of the.2011 edition);
---Added requirements for temperature adaptability (see 4.2.7);
---Added the requirements for corrosion resistance (see 4.4);
---Modified the pyrogen-free requirements and test methods (see 4.5.2, 5.5.2, 4.4.3 and 5.4.3 of the.2011 edition);
---Modified the test method of tightness (see 5.2.4, 5.2.4 of the.2011 edition);
---Inductively coupled plasma mass spectrometry has been added (see 5.3.3);
--- The logo, label, instruction manual and packaging, transportation and storage have been deleted (see Chapter 6 and Chapter 7 of the.2011 edition).
Please note that certain contents of this document may involve patents. The issuing agency 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 Standardization Technical Committee for Medical Extracorporeal Circulation Equipment (SAC/TC158).
Drafting organizations of this standard. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Weigao Xinsheng Medical Devices Co., Ltd., Ningbo Filal
Medical Supplies Co., Ltd.
The main drafters of this standard. He Xiaofan, Xu Chaosheng, Xu Suhua, Liang Zexin, Xiong Wei, Wang Yi, Kong Jianming.
The previous versions of the standard replaced by this standard are as follows.
---YY 0485-2004;
---YY 0485-2011.
Cardioplegia perfusion device for single use
1 Scope
This standard specifies the structure, classification, requirements and test methods of disposable cardioplegia perfusion devices.
This standard applies to single-use cardioplegia perfusion devices (hereinafter referred to as perfusion devices). Perfusion device for cardiopulmonary bypass open heart surgery
Used for cardioplegia perfusion.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements
GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2.Locking joints
GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management
GB 18278.1 Hygrothermal Sterilization of Medical and Healthcare Products Part 1.Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices
GB 18279.1 Sterilization of medical and health care products, ethylene oxide Part 1.Requirements for the development, validation and routine control of the sterilization process of medical devices
GB 18280.1 Sterilization radiation of medical and health care products Part 1.Requirements for the development, validation and routine control of the sterilization process of medical devices
GB 19335-2003 General technical requirements for single-use blood circuit products
YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method
YY/T 0681.1 Sterile medical device packaging test method Part 1.Guide to accelerated aging test
Pharmacopoeia of the People's Republic of China
3 Structure and classification
3.1 Structure
The infusion device is mainly composed of pump tube, thermostat and connecting tube.
3.2 Classification
This standard stipulates that the perfusion device is divided into A and B; the thermostat needs to be connected to the heat exchange water tank as A type, and the thermostat using ice-water mixture is B.
4 requirements
4.1 Appearance
4.1.1 It should be clean and free of foreign matter, and the blood path should be transparent or translucent.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0485-2020_English be delivered?Answer: Upon your order, we will start to translate YY 0485-2020_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 0485-2020_English with my colleagues?Answer: Yes. The purchased PDF of YY 0485-2020_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+ countriesQuestion 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 [email protected]. 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 0485-2020?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0485-2020 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.
|