YY/T 1704.2-2020 PDF in English
YY/T 1704.2-2020 (YY/T1704.2-2020, YYT 1704.2-2020, YYT1704.2-2020)
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| YY/T 1704.2-2020 | English | 110 |
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Cervical dilator for single use--Part 2: Swollen dilator
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Standards related to (historical): YY/T 1704.2-2020
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YY/T 1704.2-2020: PDF in English (YYT 1704.2-2020) YY/T 1704.2-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 36
Cervical dilator for single use - Part 2: Swollen dilator
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JANUARY 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test methods ... 7
6 Marks, packaging and instruction manual ... 8
7 Transport, storage ... 8
Cervical dilator for single use - Part 2: Swollen dilator
1 Scope
This Part of YY/T 1704 specifies the classification, requirements, test methods,
marks, packaging and instruction manual, transport, storage and sterilization
period for swollen cervical dilator for single use (hereinafter referred to as the
dilator).
This Part is applicable to the single-use swollen cervical dilator used for dilation
of the uterus in the obstetrics and gynecology and family planning departments.
This Part is not applicable to the cervical dilator made of metal.
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 14233.1-2008, Test methods for infusion transfusion injection
equipment for medical use - Part 1: Chemical analysis methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation
and testing
YY/T 0171, Surgical instruments - Packaging, Marking and Instructions
Pharmacopoeia of the People's Republic of China (2015 Edition) Part IV
3 Classification
3.1 Composition and structure
3.1.1 The dilator consists of a rod body and a placer (if any), as shown in Figure
1.
4.1.1 The rod of the dilator shall be smooth and uniform in color, and there shall
be no defects such as cracks and burrs, and the head of the rod shall be smooth.
4.1.2 The dilator placer (if any) shall be smooth and free of sharp edges and
burrs.
4.2 Dimensions
The length and diameter of the dilator rod shall meet the requirements of Table
1.
4.3 Physical properties
4.3.1 The manufacturer shall specify the use time of the dilator and provide
information on the diameter change with time after the rod has absorbed water
(during use).
4.3.2 The dilator rod body shall have no cracks in the initial state and the state
after water absorption (use time).
4.3.3 The dilator rod body and the placer (if any) shall be firmly connected in
the initial state and the state after water absorption (use time).
4.3.4 There shall be no visible falling off after the dilator rod absorbs water.
4.4 Chemical properties
4.4.1 Heavy metals
The total content of heavy metals in the dilator extract shall not exceed 1μg/mL.
4.4.2 PH
Compare the dilator extract with the blank solution. The difference in pH shall
not exceed 1.5.
4.5 Sterilization
The dilator shall be sterilized by a confirmed sterilization process, and the
sterilized dilator shall be sterile.
4.6 Residual ethylene oxide
If the dilator is sterilized by ethylene oxide, the residual amount of ethylene
oxide shall not exceed 10μg/g.
4.7 Biological evaluation
The final product of the dilator shall be evaluated according to GB/T 16886.1.
Take sample. Add water at a ratio: 0.1g of dilator (including placer, if any) to
5mL of water. Keep constant temperature at (37±1)°C for 1h. Separate the
sample from water. Cool to room temperature as the extract. Take the same
volume of water and place it in a glass container. Prepare blank control solution
in the same way.
5.4.2 Heavy metals
Test according to the method specified in 5.6.1 of GB/T 14233.1-2008, in
accordance with the requirements of 4.4.1.
5.4.3 PH
Test according to the method specified in 5.4.1 of GB/T 14233.1-2008, in
accordance with the requirements of 4.4.2.
5.5 Sterilization
It shall be carried out in accordance with the general principles "sterile test
method" of part IV of the "Pharmacopoeia of the People's Republic of China"
(Edition 2015), in accordance with the requirements of 4.5.
NOTE: Each sterilization batch undergoes an effective monitoring process to make the
product sterile.
5.6 Residual ethylene oxide
Test according to the method specified in GB/T 14233.1-2008. Use gas
chromatography in arbitration, in accordance with the requirements of 4.6.
5.7 Biological evaluation
Evaluate according to the corresponding method of biological evaluation, in
accordance with the requirements of 4.7.
6 Marks, packaging and instruction manual
The marks, packaging and instruction manual of the dilator shall comply with
the provisions of YY/T 0171.
7 Transport, storage
7.1 Transport
Packaging and transportation requirements are in accordance with the
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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