YY 0286.3-2017_English: PDF (YY0286.3-2017)
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Special infusion sets -- Part 3: Light-resistant infusion sets for single use
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YY 0286.3-2017
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Standards related to: YY 0286.3-2017
| Standard ID | YY 0286.3-2017 (YY0286.3-2017) | | Description (Translated English) | Special infusion sets--Part 3: Light-resistant infusion sets for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,146 | | Date of Issue | 2017-07-17 | | Date of Implementation | 2019-01-01 | | Older Standard (superseded by this standard) | GB 18458.3-2005 | | Drafting Organization | Shandong Province Medical Device Product Quality Inspection Center, Wuhan Zhixun a source of Science and Technology Development Co., Ltd., Shandong Xinhua Andean medical supplies Co., Ltd., Jiangxi Hongda Medical Devices Co., Ltd., Tianjin Hanna Good Medical Co., Ltd., Beijing Volta Technology Co., Ltd., Shandong Weigao Group Medical Polymer Co., Ltd., Klinio Medical Devices (Nanchang) Co., Ltd., Jiangxi Sanxin Medical Technology Co., Ltd. | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 84 | | Issuing agency(ies) | State Food and Drug Administration | YY 0286.3-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Special infusion sets –
Part 3. Light-resistant infusion sets for single use
ISSUED ON. JULY 17, 2017
IMPLEMENTED ON. JANUARY 1, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 7
2 Normative references ... 7
3 General requirements ... 7
4 Materials ... 7
5 Physical requirements ... 7
6 Chemical requirements ... 8
7 Biological requirements ... 8
8 Marks ... 8
9 Packaging ... 8
10 Type inspection ... 8
Annex A (normative) Transmittance measurement ... 9
Annex B (normative) Discoloration test - physical method ... 11
Annex C (normative) Discoloration chemical test method – visual colorimetry
... 12
Foreword
All content of this Part is mandatory.
YY 0286 "Special infusion sets" consists of 6 parts.
- Part 1. Infusion sets with precision filters for single use;
- Part 2. Fluid lines for use with pressure infusion equipment and
accessories for single use;
- Part 3. Light-resistant infusion sets for single use;
- Part 4. Single-use infusion equipment for use with pressure infusion
apparatus;
- Part 5. Bottle-type and bag-type infusion sets for single use;
- Part 6. Flow rate-setting and adjustable infusion sets for single use.
This Part is Part 3 of YY 0286.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part was formulated based on GB 18458.3-2005 "Special infusion sets -
Part 3 . Light-resistant infusion sets for single use". Compared with GB 18458.3-
2005, in addition to editorial modifications, the main technical changes are as
follows.
- modified the introduction;
- deleted the marking requirements;
- added 65% ethanol (CH3CH2O) aqueous solution and 50% polyethylene
glycol 400 aqueous solution in extraction solution in Annex C.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Part shall be under the jurisdiction of National Technical Committee on
Medical Infusion Apparatus of Standardization Administration of China
(SAC/TC 106).
The drafting organizations of this Part. Shandong Medical Device Quality
Inspection Center, Wuhan Zhixun Chuangyuan Technology Development Co.,
Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Jiangxi Hongda
Medical Instrument Co., Ltd., Tianjin Hana Medical Materials Co., Ltd., Beijing
Introduction
With the continuous development of infusion technology and the increasing
clinical requirements, some infusion sets that can adapt to specific clinical
requirements have been produced one after another. Since the development of
the product is endless, it is not possible to include all the special requirements
of the infusion set in a standard. Therefore, each part of YY 0286 regulates
these specialized infusion sets only for one clinical special requirement. Some
specialized infusion sets may belong to a variety of special infusion sets, and
the applicable parts of YY 0286 shall be executed at the same time.
Some drugs in the clinic need to be transfused in dark conditions, such as
sodium nitroprusside, nitroglycerin, and vitamin B2. Common infusion sets that
comply with GB 8368 cannot meet this infusion requirement. Therefore, it is
necessary to use the light-proof infusion device specified in this Part of YY 0826.
All components of light-resistant infusion sets that are in connection with the
liquid are required to have light resistance. This Part only specifies the light
resistance performance for the drip bucket and the pipe. Since other
components are limited by their dimensions, they are not subject to light
resistance requirements and are controlled by the manufacturer. It is the
responsibility of the device manufacturer to protect light-resistant infusion sets
from stabilizing during shelf life without discoloration. Standard Annex B and
Annex C give methods for decolorization evaluation of light-resistant infusion
sets. The four alternative solvents given in Annex C are more suitable for device
manufacturer to perform decolorization test.
The device packaging shall identify the drugs that are known to be incompatible.
The current methods to realize light resistance of infusion sets include.
- monolayer structure made from light-resistant pellets;
- composite structure made of light- resistant layer and non-light- resistant
layer;
- partial shielding of the use of shading devices (such as light-resistant
hood on drop bucket);
- combination the above methods.
For light-resistant infusion sets equipped with a shading device, the light-
resistant test of this Standard does not apply to shielded parts.
For the infusion sets made of a combination of a light-resistant layer and a non-
light- resistant layer, the influence of the thickness of each layer, the total wall
Special infusion sets -
Part 3. Light-resistant infusion sets for single use
1 Scope
This Part of YY 0286 specifies the single use of fluid material added with light-
resistant agent, requirements for gravity infusion type infusion set, hereinafter
referred to as “the light-resistant infusion sets”.
This Part also provides guidelines for the performance of materials used in light-
resistant infusion sets and their quality specifications.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 601-2002, Chemical Reagent - Preparations of Standard Volumetric
Solutions
GB 8368, Infusion sets for single use - Gravity feed
3 General requirements
The requirements specified in GB 8368 apply to this document.
4 Materials
Materials for production of light-resistant infusion sets and their components
shall meet the requirements of Clause 5. The components of the light-resistant
infusion sets that are in connection with liquid medicine shall also meet the
requirements specified in Clauses 6 and 7.
5 Physical requirements
5.1 General
Annex C
(normative)
Discoloration chemical test method – visual colorimetry
C.1 General
Discoloration chemical test method – visual colorimetry selects 4 different
solutions for 2h cycle test.
C.2 Solution preparation
C.2.1 c[HCL]=0.1 mol/L hydrochloric acid solution. prepare 1000 mL
according to the provisions of 4.2 in GB 601-2002;
C.2.2 c[NaOH]=0.1 mol/L sodium hydroxide solution. weigh 4.000 g of sodium
hydroxide and dilute to 1000 mL with water.
C.2.3 65% ethanol (CH3CH2O) aqueous solution. measure 650 mL of
absolute ethanol and dilute to 1000 mL with water.
C.2.4 50% of polyethylene glycol 400 aqueous solution. measure 500 mL of
polyethylene glycol 400, add water to dilute to 1000 mL.
C.3 Preparations of extract solution and blank solution
Three sterilized light-protected infusion sets and a 300-mL silicon-boro-boron
glass flask are connected into a closed-loop system. Place the flask on the
heater to maintain the temperature of the liquid in the flask at (37±1)°C. Add
250 mL of a solution for leaching given in C.2 and circulate for 2h at 1 L/h. For
example, use a peristaltic pump on a shortest possible silicone rubber tube.
Collect all liquids and cool to obtain extract solution.
Use the same solution for extraction. Use same method to prepare blank
solution without infusion sets.
C.4 Test steps
Take 50 mL of the extracted solution in the corresponding Nessler colorimetric
tube. Take another 50mL Nessler colorimetric tube. Add 50mL of the
corresponding blank solution. Place under the white background and observe
from the top. Compare the color.
C.5 Results representation
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