YY 0585.3-2018_English: PDF (YY0585.3-2018)
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Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters
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| Standard ID | YY 0585.3-2018 (YY0585.3-2018) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,198 | | Date of Issue | 2018-11-07 | | Date of Implementation | 2020-05-01 | | Older Standard (superseded by this standard) | YY 0585.3-2005 | | Quoted Standard | GB/T 1962.2; GB 8368; YY/T 0466.1 | | Adopted Standard | ISO 8536-11-2015, MOD | | Drafting Organization | Shandong Medical Device Product Quality Inspection Center | | Administrative Organization | National Medical Infusion Device Standardization Technical Committee | | Regulation (derived from) | Announcement No. 87 of 2018 by the State Drug Administration | | Summary | This standard specifies the design, materials, physics, chemistry and biology, packaging, labeling, disposal and other requirements of filters for pressure infusion equipment, excluding the effectiveness of filters to filter out particles or bacteria. This standard applies to liquid infusion equipment for pressures up to 200 kPa and disposable infusion filters for infusion sets specified in YY 0286.4. | | Standard ID | YY 0585.3-2005 (YY0585.3-2005) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 8,888 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Adopted Standard | ISO 8536-11-2004, IDT | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | Industry Standard Notice 2006 No. 2 (No. 74 overall) | | Proposing organization | National Standard Committee on Medical Infusion Equipment | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to the liquid line pressure infusion equipment and YY 0286. 4 on the prescribed pressure infusion infusion with a single-use sterile filters. Excluding filter to remove particles or bacterial effectiveness. |
YY 0585.3-2018
Fluid lines for use with pressure infusion equipment and accessories for single use.Part 3. Filters
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0585.3-2005
Disposable liquid path and accessories for pressure infusion equipment
Part 3. Filters
singleuse-Part 3.Filters
(ISO 8536-11.2015, Infusionequipmentformedicaluse-
Part 11. Infusionfiltersforusewithpressureequipment, MOD)
Published on.2018-11-07
2020-05-01 implementation
State Drug Administration issued
Foreword
All technical content in this section is mandatory.
YY 0585 "Disposable Liquid Road and Accessories for Pressure Infusion Equipment" is divided into four parts.
--- Part 1. Liquid path;
--- Part 2. Accessories;
--- Part 3. Filters;
--- Part 4. Backflow prevention valve.
This part is the third part of YY 0585.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0585.3-2005 "Disposable liquid passages and accessories for pressure infusion equipment Part 3. Filters", and
Compared with YY 0585.3-2005, the main technical changes except editorial changes are as follows.
--- Revised the degree of adoption, modified from the equivalent use to "modified adoption";
--- Removed the Chapter 3 tag;
---Modified the requirements of the 5.5 in-band and/or outer conical joints, and deleted the corresponding test method A.5;
--- Revised the requirements of the Chapter 9 label, added the available ISO 7000 symbol 2725 indicating that there is a certain material of interest
In the request;
--- Added the requirements for the disposal of Chapter 10;
--- Revised the A.4 leak test method in Appendix A and removed the negative pressure test.
This part is modified to use ISO 8536-11.2015 "medical infusion devices - Part 11. Disposable infusions for pressure infusion devices
filter".
There are technical differences between this section and ISO 8536-11.2015. 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 Appendix D, Appendix B, and Appendix C are added, and the corresponding technicality is given.
A list of differences and their causes.
This section also made the following editorial changes.
--- Added informative Appendix D, giving a list of technical differences and their causes compared to ISO 8536-11.2015.
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, Fresenius Kabi (China) Investment Co., Ltd., Shandong New
Huaande Medical Products Co., Ltd. and Shandong Weigao Group Medical Polymer Products Co., Ltd.
The main drafters of this section. Jia Yufei, Hong Mei, Sun Shouyi, Li Weiyang, Xia Jie.
The previous versions of the standards replaced by this section are.
---YY 0585.3-2005.
Disposable liquid path and accessories for pressure infusion equipment
Part 3. Filters
1 Scope
This part of YY 0585 specifies the design, materials, physics, chemistry and biology, packaging, labeling, of filters for pressure infusion equipment.
Disposal requirements, etc., do not include the effectiveness of the filter to filter out particles or bacteria.
This section applies to the liquid path for infusion equipment not exceeding.200 kPa and the one-time use on the infusion set specified in YY 0286.4
Sterile infusion filter.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies 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 1962.2-2015, ISO 594-2.1998, IDT)
1) GB/T 1962 will be replaced by Part 7 of the YY/T 0916 series of standards (ISO 80369-7.2015, IDT).
GB 8368 Disposable Infusion Set Gravity Infusion (GB 8368-2018, ISO 8536-4.2010, MOD)
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)
Chinese Pharmacopoeia
3 design
The infusion filter housing should provide an exhaust system to prevent condensed air bubbles from clogging the filter.
4 materials
The materials used to make the infusion filter shall meet the requirements specified in Chapters 5, 6, and 7.
5 Physical requirements
5.1 Transparency
The filter housing shall be transparent and shall be capable of distinguishing the interface between water and air when tested in accordance with A.1 of Appendix A.
5.2 particulate pollution
Infusion filters should be produced under conditions of minimal particulate contamination. The inner surface should be smooth and clean. When tested in accordance with the provisions of A.2, it shall not exceed the pollution
Dyeing index.
......
YY 0585.3-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0585.3-2005 / ISO 8536-11.2004
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 3. Filters
(ISO 8536-11.2004, Infusion equipment for medical use –
Part 11. Infusion filters for use with pressure infusion equipment, IDT)
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Designation ... 4
4 Design... 4
5 Materials ... 5
6 Physical requirements ... 5
7 Chemical requirements ... 5
8 Biological requirements ... 5
9 Packaging... 6
10 Labelling ... 6
Annex A (Normative) Physical tests ... 8
Annex B (Normative) Chemical tests ... 10
Annex C (Normative) Biological tests ... 11
Bibliography ... 12
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 3. Filters
1 Scope
This Part of YY 0585 applies to sterilized infusion filters for single use up to 200 kPa (2 bar)
on fluid lines of pressure infusion equipment and infusion set as specified in YY 0286.4. It
does not include the effectiveness of filters for separation of particles or germs.
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0585 when they are quoted herein. For the dated documents so quoted, all the
modifications (excluding corrections) or revisions made thereafter shall not be applicable
to this Part. For the undated documents so quoted, the latest editions shall be applicable
to this Part.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain
other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1994)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-4.2004,
MOD)
YY 0286.4 Special infusion sets - Part 4. Single-use infusion equipment for use with
pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8.2004, IDT)
YY 0466 Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied (YY 0466-2003, ISO 15223.2000, IDT)
3 Designation
Designation of an infusion filter (IF) for infusions under pressure (P).
Infusion filter YY 0585.3-IF-P
4 Design
The infusion filter housing shall be provided with a venting system to anticipate the
blocking of the filter by the accumulation of air bubbles.
Bibliography
[1] GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for
interactions with blood (GB/T 16886.4-2003, ISO 10993-4, IDT)
[2] GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical
use - Part 2.Biological test methods
[3] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[4] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994)
[5] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[6] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[7] Chinese Pharmacopoeia
[8] ISO 31-3 Quantities and units - Part 3. Mechanics
......
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