YY 0030-2004Peritoneal dialysis catheters (English PDF)
腹膜透析管
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
July 16, 2004
Implementation date
August 1, 2005
Scope
YY 0030-2004 is the English-translated version of 腹膜透析管.
YY 0030-2004 is the Chinese pharmaceutical industry standard for peritoneal dialysis catheters, the long-term catheters, made mainly of silicone elastomer tube with one or more polyester cuffs, that are placed in the abdominal cavity of patients with renal failure.
It defines the catheter and the cuff and sets general requirements and functional performance: flow of at least 100 mL/min, bending resistance, connection strength at the connector and cuffs, freedom from leakage under 50 kPa, X-ray detectability where claimed and sterilization, with physical tests taken from GB/T 15812.1 and a normative annex on cuff connection strength.
Biological properties follow YY 0334 and packaging and marking YY/T 0313. It revises YY 0030-1990, dropping the old physical and mechanical tests of the tube. Issued on 16 July 2004, it has applied since 1 August 2005.
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Document preview — YY 0030-2004
National Standard of the People's Republic of China
- Replacing
- YY 0030-1990
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative References5
- 3 Terms and Definitions5
- 4 General Requirements6
- 5 Functional performance6
- 6 Marking8
- 7 Packaging8
- Appendix A (Normative) Cuff Connection Firmness Test9
- Bibliography10
Foreword
This Standard is a revision of YY 0030-1990. In this revision, the physical and mechanical properties of silicone elastomer tube are deleted; the physical properties of catheters implement GB/T 15812.1. Therefore, internationally universal test methods are adopted. The biochemical properties of silicone elastomer tube implement the stipulations in YY 0334. The requirements of packaging and marking implement the requirements in YY/T 0313. Appendix A in this Standard is normative.
1 Scope
This Standard specifies the general requirements of peritoneal dialysis catheters, which are mainly manufactured from silicone elastomer.
2 Normative References
Through the reference in this Standard, the clauses in the following documents become clauses of this Standard. In terms of references with a specific date, all the subsequent modification lists (excluding the corrected content) or revised editions are not applicable to this Standard. However, all parties that reach an agreement in accordance with this Standard are encouraged to explore the possibility of adopting the latest version of these documents. In terms of references without a specific date, the latest version is applicable to this Standard.
GB 12417 The General Technological Conditions of Surgical Metal Implant
GB/T 15812.1-1) Catheters other than Intravascular Catheters - Part 1. Test Methods for Common Properties (EN 1618. 1997, IDT)
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1. Evaluation and Testing (GB/T 16886.1-2001, idt ISO 10993-1. 1997)
YY/T 0313-1998 Package, Label, Transport and Storage for Medical Polymer Products
YY 0334 General Specification for Surgical Implants Made of Silicone Elastomer
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 Peritoneal Dialysis Catheter
Peritoneal dialysis catheter refers to catheter, which is inserted into renal failure patients' abdominal cavity for peritoneal dialysis in the long term. Generally speaking, the catheter is constituted of silicone elastomer tube and cuff.
3.2 Cuff
Cuff refers to a section of cyclic annular substance (mainly made of polyester material)
5 Functional performance
5.4 Flow
In the test conducted in accordance with Appendix E in GB/T 15812.1, the flow shall be not less than 100 mL/min.
5.5 Bending Resistance
NOTE: after test method is determined, this requirement will be stipulated; the test method will be provided in GB/T 15812.2.
5.6 Firmness of Connection
5.6.1 If connector is equipped, in the test conducted in accordance with Appendix F in GB/T 15812.1, the minimum breaking force at the junction of the connector and the silicone elastomer tube shall be not less than 15 N. In terms of peritoneal dialysis catheter which has closures on the head end of the in vivo segment, the minimum breaking force of its connection shall be not less than 10 N.
5.6.2 In the test conducted in accordance with Appendix A, cuffs shall be able to bear 10 N of tensile force in the axial direction for 15 s, and do not become loosened.
5.7 No Leakage
If connector is equipped, assemble it in accordance with the instruction of the manufacturer. In the test conducted in accordance with Appendix C in GB/T 15812.1, the connector and the silicone elastomer tube shall be able to bear 50 kPa of pressure, and do not manifest any leakage.
5.8 Ray Detectability
If the manufacturer claims that it is ray detectable, corresponding test evidences shall be provided.
NOTE: it is recommended that ASTM F 640 can be taken as a reference in evaluation.
5.9 Sterilization
Peritoneal dialysis catheter shall go through a sterilization process which is already confirmed. In addition, instruction on the method of re-sterilization shall be provided.
NOTE 1. please refer to Bibliography for appropriate sterilization methods.
NOTE 2. GB/T 14233.2 stipulates the method of sterility test, but this method should not be applied to exit-factory inspection.
NOTE 3. when ethylene oxide is adopted for sterilization, the residual of ethylene oxide belongs to the content of sterilization validation. Please refer to GB/T 16886.7 for the release control. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 15812.1-1Catheters other than intravascular catheters -- Part 1: Test methods for common for properties
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0313-1998Medical polymer products—Requirement for package and information supplied by manufacturer
- YY 0334General specification for surgical implants made of silicone elastomer
GB 12417
Similar standards
Editions of YY 0030
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0030-2004 | Peritoneal dialysis catheters | current edition | Current |
| YY 0030-1990 | Peritoneal dialysis catheters | previous edition | Superseded |
This page sells the current edition, YY 0030-2004. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY 0334-2002 — General specification for surgical implants made of silicone elastomer
YY/T 0313-1998 — Packaging, labelling, transport and storage of medical polymer products
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