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YY/T 1734-2020: Iodine liquid protective cap for peritoneal dialysis
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1734-2020 | English | 189 |
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Iodine liquid protective cap for peritoneal dialysis
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YY/T 1734-2020
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Basic data | Standard ID | YY/T 1734-2020 (YY/T1734-2020) | | Description (Translated English) | Iodine liquid protective cap for peritoneal dialysis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040 | | Word Count Estimation | 10,142 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Issuing agency(ies) | State Drug Administration | YY/T 1734-2020: Iodine liquid protective cap for peritoneal dialysis---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.
Iodine liquid protective cap for peritoneal dialysis
ICS 11.040
C45
People's Republic of China Pharmaceutical Industry Standard
Iodine solution protective cap for peritoneal dialysis
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency 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, Guangzhou Baxter Medical Products Co., Ltd., Weigao Taiermao (Weigao
Hai) Medical Products Co., Ltd., Ningbo Tianyi Medical Equipment Co., Ltd.
The main drafters of this standard. Yan Lin, Dang Xiyun, Wu Wei, Liang Zexin, Yuan Fengjiao, Wu Zhimin.
Iodine solution protective cap for peritoneal dialysis
1 Scope
This standard specifies the terms and definitions, composition, requirements and test methods of iodine solution protective caps for peritoneal dialysis (hereinafter referred to as iodine solution protective caps)
law. The iodine solution protective cap is used to assist the peritoneal dialysis treatment, and is used for one-time disinfection protection during peritoneal dialysis.
This standard applies to iodine solution protective caps in peritoneal dialysis (also called iodine solution mini caps, iodophor caps, etc.).
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 6682 Analytical laboratory water specifications and test methods
GB/T 13074 Terminology for blood purification
Pharmacopoeia of the People's Republic of China
Disinfection technical specifications
3 Terms and definitions
The following terms and definitions defined in GB/T 13074 apply to this document.
4 composition
The iodine solution protective cap consists of a cap body, a sponge soaked in iodine solution and other components. The iodine solution should meet the requirements of the "Pharmacopeia of the People's Republic of China".
Note. In this standard, iodine solution refers to povidone-iodine solution.
5 requirements
5.1 Appearance
The outer surface of the iodine solution protective cap should be clean and free of impurities.
5.2 Physical properties
5.2.1 No leakage
There should be no gas leakage when the iodine liquid protective cap is connected to the supporting devices.
5.2.2 Compatibility
There should be no leakage of iodine solution or exposure of the sponge when the iodine solution protective cap is connected with the supporting devices.
5.2.3 Torsion resistance
When tested according to 6.2.3, the cap body should be free from damage, and there should be no gas leakage when connected to the supporting devices.
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