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YY 0585.2-2019

Chinese Standard: 'YY 0585.2-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0585.2-2019English209 Add to Cart Days<=3 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories Valid YY 0585.2-2019
YY 0585.2-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY 0585.2-2019 (YY0585.2-2019)
Description (Translated English) Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 10,130
Date of Issue 2019-05-31
Date of Implementation 2020-12-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Shandong Xinhua Ande Medical Products Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC 106)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY 0585.2-2019
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2. Accessories
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0585.2-2005
Disposable liquid path and accessories for pressure infusion equipment
Part 2. Accessories
Fluidlinesforusewithpressureinfusionequipmentandaccessoriesforsingleuse-
Part 2.Accessories
(ISO 8536-10.2015, MOD)
Published on.2019-05-31
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 second part of YY 0585.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0585.2-2005, compared with YY 0585.2-2005, added funds after Appendix A, Appendix B and Appendix C.
In addition to the editorial changes, the main technical changes are as follows.
--- Revised the degree of adoption, changed from "IDT" (equivalent adoption) to "MOD" (modified use);
---Delete Chapter 3 markup;
---Modify the requirements of 4.8 devices with injection parts;
---Modified the requirements of the 4.9 device with anti-backflow valve, and deleted A.8;
--- Modify the requirements of Chapter 6 biology for GB 8368 to facilitate implementation;
--- Modify the requirements of the Chapter 8 label, and increase the available ISO 7000 symbol 2725 to indicate the presence of a substance of interest
Requirements
--- Increase the requirements for the disposal of Chapter 9;
--- Amend the A.4 leak test method and remove the negative pressure test;
--- Removed the leak test of the A.5 in-band and/or outer conical joints.
This section is modified to use ISO 8536-10.2015 "Medical Infusion Sets Part 10. Accessories for Liquid Lines for Pressure Infusion Equipment".
There are technical differences between this part and ISO 8536-10.2015. Appendix D gives the corresponding technical differences and their causes.
Watch list.
This section also made the following editorial changes.
--- Added informative Appendix D, giving a list of technical differences and their causes compared to ISO 8536-10.2015.
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 Xinhua Ande Medical Supplies Co., Ltd., Shandong Weigao
Group Medical Polymer Products Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
The main drafters of this section. Shi Yanping, Sun Shouyi, Li Weiyang, Hong Mei, Ai Chongchong.
The previous versions of the standards replaced by this section are.
---YY 0585.2-2005.
Disposable liquid path and accessories for pressure infusion equipment
Part 2. Accessories
1 Scope
This part of YY 0585 specifies the physical, chemical and biological requirements for accessories for pressure infusion equipment.
This section applies to disposable sterile fluid circuits and accessories for pressure infusion sets as defined in YY 0286.4, including.
a) two-way switch (2SC), three-way switch (3SC), four-way switch (4SC) and multi-switch (SM);
Note. The marking of the switch depends on the number of connections and may be supplemented by a supplementary description of the number of possible functional positions. If you use a slash and switch
The number of positions that can be indicated by the number. For example, a 3/4-way switch indicates a three-way switch with four possible positions.
b) device with injection device (UIS) or device with backflow prevention valve (UCV);
c) Plug (S) or connector (A).
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)
YY 0286.4 special infusion sets - Part 4. Infusion sets for single-use pressure infusion equipment (YY 0286.4-2006,
ISO 8536-8.2004, IDT)
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 0585.4 Disposable liquid passages and accessories for pressure infusion equipment - Part 4. Backflow preventer (YY 0585.4-2009,
ISO 8536-12.2007, MOD)
Chinese Pharmacopoeia
3 materials
The materials used to manufacture the accessories shall meet the requirements specified in Chapters 4, 5 and 6.
4 Physical requirements
4.1 Avoid air bubbles
All components of the attachment shall be designed so that no air bubbles are detected in the flow path when tested in accordance with A.1 of Appendix A.
4.2 particulate pollution
The accessories should be produced under conditions of minimum particulate contamination. The surface of the liquid passage should be smooth and clean. When tested in accordance with the provisions of A.2, it shall not exceed the pollution
Dyeing index.
YY 0585.2-2019
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2. Accessories
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0585.2-2005
Disposable liquid path and accessories for pressure infusion equipment
Part 2. Accessories
Fluidlinesforusewithpressureinfusionequipmentandaccessoriesforsingleuse-
Part 2.Accessories
(ISO 8536-10.2015, MOD)
Published on.2019-05-31
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 second part of YY 0585.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0585.2-2005, compared with YY 0585.2-2005, added funds after Appendix A, Appendix B and Appendix C.
In addition to the editorial changes, the main technical changes are as follows.
--- Revised the degree of adoption, changed from "IDT" (equivalent adoption) to "MOD" (modified use);
---Delete Chapter 3 markup;
---Modify the requirements of 4.8 devices with injection parts;
---Modified the requirements of the 4.9 device with anti-backflow valve, and deleted A.8;
--- Modify the requirements of Chapter 6 biology for GB 8368 to facilitate implementation;
--- Modify the requirements of the Chapter 8 label, and increase the available ISO 7000 symbol 2725 to indicate the presence of a substance of interest
Requirements
--- Increase the requirements for the disposal of Chapter 9;
--- Amend the A.4 leak test method and remove the negative pressure test;
--- Removed the leak test of the A.5 in-band and/or outer conical joints.
This section is modified to use ISO 8536-10.2015 "Medical Infusion Sets Part 10. Accessories for Liquid Lines for Pressure Infusion Equipment".
There are technical differences between this part and ISO 8536-10.2015. Appendix D gives the corresponding technical differences and their causes.
Watch list.
This section also made the following editorial changes.
--- Added informative Appendix D, giving a list of technical differences and their causes compared to ISO 8536-10.2015.
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 Xinhua Ande Medical Supplies Co., Ltd., Shandong Weigao
Group Medical Polymer Products Co., Ltd., Fresenius Kabi (China) Investment Co., Ltd.
The main drafters of this section. Shi Yanping, Sun Shouyi, Li Weiyang, Hong Mei, Ai Chongchong.
The previous versions of the standards replaced by this section are.
---YY 0585.2-2005.
Disposable liquid path and accessories for pressure infusion equipment
Part 2. Accessories
1 Scope
This part of YY 0585 specifies the physical, chemical and biological requirements for accessories for pressure infusion equipment.
This section applies to disposable sterile fluid circuits and accessories for pressure infusion sets as defined in YY 0286.4, including.
a) two-way switch (2SC), three-way switch (3SC), four-way switch (4SC) and multi-switch (SM);
Note. The marking of the switch depends on the number of connections and may be supplemented by a supplementary description of the number of possible functional positions. If you use a slash and switch
The number of positions that can be indicated by the number. For example, a 3/4-way switch indicates a three-way switch with four possible positions.
b) device with injection device (UIS) or device with backflow prevention valve (UCV);
c) Plug (S) or connector (A).
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)
YY 0286.4 special infusion sets - Part 4. Infusion sets for single-use pressure infusion equipment (YY 0286.4-2006,
ISO 8536-8.2004, IDT)
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 0585.4 Disposable liquid passages and accessories for pressure infusion equipment - Part 4. Backflow preventer (YY 0585.4-2009,
ISO 8536-12.2007, MOD)
Chinese Pharmacopoeia
3 materials
The materials used to manufacture the accessories shall meet the requirements specified in Chapters 4, 5 and 6.
4 Physical requirements
4.1 Avoid air bubbles
All components of the attachment shall be designed so that no air bubbles are detected in the flow path when tested in accordance with A.1 of Appendix A.
4.2 particulate pollution
The accessories should be produced under conditions of minimum particulate contamination. The surface of the liquid passage should be smooth and clean. When tested in accordance with the provisions of A.2, it shall not exceed the pollution
Dyeing index.
Related standard:   YY 0585.1-2019  YY 0585.3-2018
Related PDF sample:   YY 0585.4-2009  YY 0585.1-2005
   
 
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