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YY 0585.1-2019: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines
YY 0585.1-2019
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1. Fluid lines
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0585.1-2005
Pressure infusion equipment for single use
Liquid Road and Accessories Part 1. Liquid Road
Fluidlinesforusewithpressureinfusionequipmentandaccessoriesfor
singleuse-Part 1.Fluidlines
(ISO 8536-9.2015 Infusionequipmentformedicaluse-Part 9. Fluidlinesfor
Usewithpressureinfusionequipment,MOD)
2019-05-31 released 2020-12-01 implementation
State Drug Administration issued
Foreword
YY 0585 "Disposable Liquid Circuits and Accessories for Pressure Infusion Equipment" includes the following parts.
--- Part 1. Liquid path;
--- Part 2. Accessories;
--- Part 3. Filters;
--- Part 4. Backflow prevention valve.
This part is the first part of YY 0585.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0585.1-2005 "Disposable liquid passages and accessories for pressure infusion equipment Part 1. Liquid road". versus
Compared with YY 0585.1-2005, the main technical changes except editorial changes are as follows.
--- Updated the normative reference file;
--- Removed the original Chapter 3 markup and added Chapter 3 terms and definitions;
--- Revised the requirements of 5.5;
--- Revised the requirements of 5.8 and added a test method for the normative Appendix C stock volume;
--- Revised the requirements of 5.9 and A.5 test methods;
--- Revised the requirements of the Chapter 9 label;
--- Added the requirements for the disposal of Chapter 10;
--- Modified the A.4 test method;
--- Removed the original A.5 test method;
--- Updated references.
This part of the amendment uses ISO 8536-9.2015 "medical infusion equipment part 9. liquid circuit for pressure equipment".
There are technical differences between this section and ISO 8536-9.2015. The terms involved in these differences have been blanked on the outside of the page.
The vertical single line (-) of the position is marked, and a list of the corresponding technical differences and their causes is given in Appendix D.
This section also made the following editorial changes.
--- Added Appendix D to Appendix A, Appendix B and Appendix C, giving the corresponding technology compared to ISO 8536-9.2015
A list of sexual differences and their causes.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Shandong Weigao Group Medical Polymer Products Co., Ltd.
Division, Shandong Xinhua Ande Medical Products Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
The main drafters of this section. Lu Wenbo, Li Weiyang, Sun Shouyi, Hong Mei, Yao Xiujun.
The previous versions of the standards replaced by this section are. YY 0585.1-2005.
Pressure infusion equipment for single use
Liquid Road and Accessories Part 1. Liquid Road
1 Scope
This part of YY 0585 specifies the physical, chemical and biological requirements for disposable sterile fluid routes for pressure infusion equipment.
This section applies to single-use sterile fluid circuits for pressure infusion equipment with a maximum pressure of.200 kPa, including.
a) Syringe pump line (SPL);
b) connecting line (CL);
c) A tubing (LIC) integral with the injection cannula.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.21) Syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB 8368 Disposable Infusion Set Gravity Infusion (GB 8368-2018, ISO 8536-4.2010, MOD)
GB 15811 single-use sterile injection needle (GB 15811-2016, ISO 7864.1993, NEQ)
GB 18671 single use intravenous infusion needle
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
YY 0585.2 Disposable liquid passages and accessories for pressure infusion equipment - Part 2. Accessories (YY 0585.2-2019,
ISO 8536-10.2015, MOD)
YY 0585.3 Disposable liquid passages and accessories for pressure infusion equipment - Part 3. Filters (YY 0585.3-2018,
ISO 8536-11.2015, MOD)
YY 1282 single use intravenous indwelling needle
1) GB/T 1962 will be replaced by Part 7 of the YY/T 0916 System Standard (ISO 80369-7.2015, IDT).
Chinese Pharmacopoeia
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Filling volume Filingvolume, VF
The volume of the tubing is filled by gravity and the tubing remains unstressed.
Note. The filling volume is equivalent to the calculated volume of the pipe.
3.2
Storage volume storagevolume, VS
The volume of the tubing under pressure, which is the sum of the filling volume (VF) and the pellet volume (VB). VS=VF VB
YY 0585.1-2019
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1. Fluid lines
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0585.1-2005
Pressure infusion equipment for single use
Liquid Road and Accessories Part 1. Liquid Road
Fluidlinesforusewithpressureinfusionequipmentandaccessoriesfor
singleuse-Part 1.Fluidlines
(ISO 8536-9.2015 Infusionequipmentformedicaluse-Part 9. Fluidlinesfor
Usewithpressureinfusionequipment,MOD)
2019-05-31 released 2020-12-01 implementation
State Drug Administration issued
Foreword
YY 0585 "Disposable Liquid Circuits and Accessories for Pressure Infusion Equipment" includes the following parts.
--- Part 1. Liquid path;
--- Part 2. Accessories;
--- Part 3. Filters;
--- Part 4. Backflow prevention valve.
This part is the first part of YY 0585.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0585.1-2005 "Disposable liquid passages and accessories for pressure infusion equipment Part 1. Liquid road". versus
Compared with YY 0585.1-2005, the main technical changes except editorial changes are as follows.
--- Updated the normative reference file;
--- Removed the original Chapter 3 markup and added Chapter 3 terms and definitions;
--- Revised the requirements of 5.5;
--- Revised the requirements of 5.8 and added a test method for the normative Appendix C stock volume;
--- Revised the requirements of 5.9 and A.5 test methods;
--- Revised the requirements of the Chapter 9 label;
--- Added the requirements for the disposal of Chapter 10;
--- Modified the A.4 test method;
--- Removed the original A.5 test method;
--- Updated references.
This part of the amendment uses ISO 8536-9.2015 "medical infusion equipment part 9. liquid circuit for pressure equipment".
There are technical differences between this section and ISO 8536-9.2015. The terms involved in these differences have been blanked on the outside of the page.
The vertical single line (-) of the position is marked, and a list of the corresponding technical differences and their causes is given in Appendix D.
This section also made the following editorial changes.
--- Added Appendix D to Appendix A, Appendix B and Appendix C, giving the corresponding technology compared to ISO 8536-9.2015
A list of sexual differences and their causes.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Shandong Weigao Group Medical Polymer Products Co., Ltd.
Division, Shandong Xinhua Ande Medical Products Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
The main drafters of this section. Lu Wenbo, Li Weiyang, Sun Shouyi, Hong Mei, Yao Xiujun.
The previous versions of the standards replaced by this section are. YY 0585.1-2005.
Pressure infusion equipment for single use
Liquid Road and Accessories Part 1. Liquid Road
1 Scope
This part of YY 0585 specifies the physical, chemical and biological requirements for disposable sterile fluid routes for pressure infusion equipment.
This section applies to single-use sterile fluid circuits for pressure infusion equipment with a maximum pressure of.200 kPa, including.
a) Syringe pump line (SPL);
b) connecting line (CL);
c) A tubing (LIC) integral with the injection cannula.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.21) Syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB 8368 Disposable Infusion Set Gravity Infusion (GB 8368-2018, ISO 8536-4.2010, MOD)
GB 15811 single-use sterile injection needle (GB 15811-2016, ISO 7864.1993, NEQ)
GB 18671 single use intravenous infusion needle
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
YY 0585.2 Disposable liquid passages and accessories for pressure infusion equipment - Part 2. Accessories (YY 0585.2-2019,
ISO 8536-10.2015, MOD)
YY 0585.3 Disposable liquid passages and accessories for pressure infusion equipment - Part 3. Filters (YY 0585.3-2018,
ISO 8536-11.2015, MOD)
YY 1282 single use intravenous indwelling needle
1) GB/T 1962 will be replaced by Part 7 of the YY/T 0916 System Standard (ISO 80369-7.2015, IDT).
Chinese Pharmacopoeia
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Filling volume Filingvolume, VF
The volume of the tubing is filled by gravity and the tubing remains unstressed.
Note. The filling volume is equivalent to the calculated volume of the pipe.
3.2
Storage volume storagevolume, VS
The volume of the tubing under pressure, which is the sum of the filling volume (VF) and the pellet volume (VB). VS=VF VB