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YY 0030-2004 English PDF (YY0030-2004)

YY 0030-2004 English PDF (YY0030-2004)

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YY 0030-2004: Peritoneal dialysis catheters

This Standard specifies the general requirements of peritoneal dialysis catheters, which are mainly manufactured from silicone elastomer.
YY 0030-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 48
Replacing YY 0030-1990
Peritoneal Dialysis Catheters
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ISSUED ON. JULY 16, 2004
IMPLEMENTED ON. AUGUST 1, 2005
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 General Requirements ... 6
5 Functional performance ... 6
6 Marking ... 8
7 Packaging ... 8
Appendix A (Normative) Cuff Connection Firmness Test... 9
Bibliography ... 10
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.
This Standard was proposed by and shall be under the jurisdiction of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices.
The drafting organization of this Standard. Shandong Quality Inspection Center for Medical Devices.
The main drafters of this Standard. Shi Yanping, Zhang Liqing, Qian Chengyu, Wanmin. Peritoneal Dialysis Catheters
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) 1) To be issued.
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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