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YY/T 0285.6-2020

Chinese Standard: 'YY/T 0285.6-2020'
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YY/T 0285.6-2020English339 Add to Cart Days<=4 Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports Valid YY/T 0285.6-2020
YY/T 0285.6-2020Chinese20 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0285.6-2020 (YY/T0285.6-2020)
Description (Translated English) Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.25
Word Count Estimation 19,189
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Braun Medical (Shanghai) International Trade Co., Ltd. Beijing Branch, Bard Medical Technology (Shanghai) Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
Administrative Organization National Standardization Technical Committee for Medical Infusion Devices (SAC/TC 106)
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0285:6-2020
(Intravascular catheters:Sterile catheters for single use:Part 6: Subcutaneous implantable drug delivery devices)
ICS 11:040:25
C31
People's Republic of China Pharmaceutical Industry Standard
Sterile catheter for single use
Part 6: Subcutaneous implantable drug delivery device
(ISO 10555-6:2015, NEQ)
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 3
4:1 General 3
4:2 Biochemical properties 3
4:3 Distance Mark 4
4:4 Nominal size of subcutaneous implantable infusion port 4
4:5 Physical requirements 4
4:6 Flow 5
4:7 Burst pressure of subcutaneously implanted infusion ports and catheters 6
5 Magnetic resonance imaging (MRI) compatibility 6
6 Information provided by the manufacturer 7
6:1 General 7
6:2 Initial packaging 7
6:3 Traceability label 7
6:4 Operating Instructions 7
Appendix A (Normative Appendix) Test Method for No Gas Leakage 8
Appendix B (informative appendix) Determination of flushing volume 9
Appendix C (informative appendix) Further characterization test guide: needle penetration and withdrawal 10
Appendix D (Normative Appendix) Test method for no leakage after multiple punctures 11
Appendix E (Normative Appendix) Piercing Debris 12
Appendix F (Normative Appendix) Peak Rally 13
Appendix G (Normative Appendix) Bend Test 14
Reference 16
Figure 1 Subcutaneous implantable infusion port 2
Figure 2 Subcutaneous implantable infusion port connected with catheter 3
Figure G:1 Bend test tool and pipe installation Figure 14
Figure G:2 Bend test system 15
Preface
YY/T 0285 "Intravascular Catheter Disposable Sterile Catheter" is divided into the following parts:
---YY 0285:1: General requirements;
---YY 0285:3: Central venous catheter;
---YY 0285:4: Balloon dilatation catheter;
---YY 0285:5: trocar peripheral catheter;
---YY/T 0285:6: Subcutaneous implantable drug delivery device:
This part is part 6 of YY/T 0285:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part uses the redrafting method to refer to ISO 10555-6:2015 ``Intravascular catheters for single use sterile catheters-Part 6: Skin
The "under implantable drug delivery device" is compiled, and the degree of consistency with ISO 10555-6:2015 is not equivalent:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part was proposed by the State Drug Administration:
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106):
Drafting organizations of this section: Shandong Medical Device Product Quality Inspection Center, Braun Medical (Shanghai) International Trade Co:, Ltd: Beijing Branch
Company, Bard Medical Technology (Shanghai) Co:, Ltd:, Fresenius Kabi (China) Investment Co:, Ltd:
The main drafters of this section: Wan Min, Liu Bin, Chen Fang, Xiong Wu, Hong Mei, Liu Dong, Liu Wanzong, Sun Lingxiao:
Sterile catheter for single use
Part 6: Subcutaneous implantable drug delivery device
1 Scope
This part of YY/T 0285 specifies the relevant performance and safety of subcutaneous implantable drug delivery devices supplied in a sterile state and for single use:
All requirements: This part is applicable to subcutaneously implanted subcutaneously implanted infusion ports and catheters that are expected to be used for long-term or long-term use in blood vessels:
Drug delivery device:
Note 1: The known subcutaneous implantable drug delivery device is also used for non-intravascular indications, such as intraperitoneal, intrathecal and epidural access: Based on risk assessment, only
Implantable drug delivery devices suitable for non-intravascular applications can refer to this section: Encourage all subcutaneous implantable drug delivery devices for non-intravascular applications
Implement the requirements of this section:
This section does not specify the performance and safety requirements related to the special needle for implantable drug delivery devices (hereinafter referred to as the special needle):
Note 2: Refer to YY 0881 for the requirements of special needles for implantable drug delivery devices:
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 Analysis and experiment water specifications and test methods
GB/T 14233:1-2008 Medical infusion, blood transfusion, injection equipment inspection methods Part 1: Chemical analysis methods
GB 15810 Sterile syringe for single use
YY 0285:1-2017 Sterile catheters for single use intravascular catheters Part 1: General requirements
YY 0285:3-2017 Sterile single-use intravascular catheters: Part 3: Central venous catheters
YY 0334-2002 General requirements for silicone rubber surgical implants
"The People's Republic of China Pharmacopoeia":2015 edition
3 Terms and definitions
The following terms and definitions defined in YY 0285:1-2017 apply to this document:
3:1
Catheter
Single-lumen or multi-lumen tubing allows its end to enter a certain point in the body:
3:2
Connection
A system that connects the catheter to the subcutaneously implantable port:
3:3
Effectivesurfacearea
The area that can be punctured by a needle:
3:4
Flushing volume
The solution volume required to completely replace one solution in the subcutaneous implantable infusion port and catheter with another solution:
Related standard: YY 0285.5-2018    YY 0285.1-2017