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YY 0030-2004: Peritoneal dialysis catheters
YY 0030-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 48
Replacing YY 0030-1990
Peritoneal Dialysis Catheters
腹膜透析管
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.