YY/T 1734-2020Iodine liquid protective cap for peritoneal dialysis (English PDF)
腹膜透析用碘液保护帽
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 1734-2020 is the English-translated version of 腹膜透析用碘液保护帽.
YY/T 1734-2020 is the Chinese pharmaceutical industry standard for the iodine protective cap used in peritoneal dialysis, the small cap containing povidone-iodine that disinfects and closes the transfer set between exchanges, also called a mini cap.
It gives the terms and definitions, the composition, the requirements and the test methods, covering the iodine content and its release, the fit and tightness of the cap on the connector, the sponge or carrier that holds the solution, the materials and their biological evaluation, and sterility. Issued on 30 June 2020, it has applied since 1 June 2021.
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Document preview — YY/T 1734-2020
National Standard of the People's Republic of China
- ICS
- 11.040
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Composition
- 5 Requirements
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.
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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
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Related Standards
GB/T 13074-2024 — Blood purification terminology
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1734-2020
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