YY/T 0931-2014 PDF in English
YY/T 0931-2014 (YY/T0931-2014, YYT 0931-2014, YYT0931-2014)
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[Including 2020XG1] Medical endoscopes -- Endotherapy device -- Loop ligature
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Standards related to (historical): YY/T 0931-2014
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YY/T 0931-2014: PDF in English (YYT 0931-2014) YY/T 0931-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Medical endoscopes - Endotherapy device - Loop
ligature
[Including No.1 Amendment 2020XG1]
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 01, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 9
6 Inspection rules ... 12
Annex A (normative) Dissolved matter test ... 13
No. 1 Amendment 2020XG1 ... 15
Medical endoscopes - Endotherapy device - Loop
ligature
1 Scope
This Standard specifies the terms and definitions, requirements, test methods
for loop ligature.
This Standard is applicable to the loop ligature that can be used as an
independent product for endoscopic surgery.
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 1962.1-2001, Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 1: General requirement
GB/T 1962.2-2001, Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2: Lock fittings
GB/T 14233.1-2008, Test methods for infusion transfusion injection
equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005, Test methods for infusion, transfusion, injection
equipment for medical use - Part 2: Biological test methods
GB/T 16886.1-2011, Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
YY/T 0149-2006, Medical instruments of stainless steel - Test methods of
corrosion resistance
YY/T 1052-2004, Marking requirements for surgical instruments
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
accordance with the principles and requirements of GB/T 16886.1, so as to
prove that they have good biocompatibility.
Biological evaluation can consider biological test results. The selection of test
items is carried out according to the guidelines of GB/T 16886.1. All tests are
given priority to the relevant parts of GB/T 16886.
For the materials that have been previously proven applicable, if it can be
proved that the follow-up process of its manufacturing is not enough to produce
biological safety hazards, the biological test cannot be repeated.
NOTE 1: When the material of the device in the design has a demonstrable history of use
in a specific application, or information about the material and/or device can be obtained
from other aspects, it can be considered that the material has been previously proven to
be applicable.
NOTE 2: If the metal material adopts the medical metal material suitable for the application
range in the national or industry standard, the biological test may not be repeated.
4.1.3 The ligature ring shall consider the following factors for the
dissolution test
4.1.3.1 After full extraction, it shall conduct quantitative and qualitative analysis
on the extract composition of the material in the extraction medium, for example,
impurities, residual monomers, additives, and other dissolved components that
may be produced by processing. The detection limit of the proposed substance
shall be determined based on the total amount acceptable to the patient in the
risk assessment, expressed in μg/g of the material.
4.1.3.2 The results of the composition analysis of the extract shall be recorded
and included in the risk assessment performed.
4.1.4 The polymer materials of the remaining contact parts shall meet the
following requirements for elution
4.1.4.1 Appearance (turbidity, color): colorless and transparent, no foreign
matter can be detected by visual inspection.
4.1.4.2 pH: pH difference is below 2.0.
4.1.4.3 Heavy metals: dissolved matter is below 5.0μg/mL.
4.1.4.4 Potassium permanganate reducing substance: the difference from the
consumption of the standard test solution is less than 2.0mL.
4.1.4.5 Evaporation residue: less than 2.0mg.
4.2 Appearance
4.4.2 Tightening strength: The manufacturer shall give the maximum tightening
force that the ligature ring can withstand in the attached information and
conduct a test to prove that the ligature ring shall not be damaged under this
tension.
4.4.3 The ligature ring shall enter and exit the outer tube smoothly and fully
extend out of the outer tube.
4.4.4 If the loop ligature has a rotation function, the rotation shall be smooth.
4.5 Toleration performance (applicable to non-disposable products)
4.5.1 High temperature and high pressure resistance
The loop ligature marked as being able to withstand high temperature and high
pressure shall be able to withstand high temperature and high pressure tests
for 20 times without damage.
4.5.2 Corrosion resistance
The part that uses stainless steel materials is tested according to the boiling
water test method in YY/T 0149-2006, in accordance with the requirements for
level b. The rest of the materials are tested according to the most unfavorable
disinfection and sterilization method specified by the manufacturer in the
instructions, which shall have good corrosion resistance.
4.5.3 Withstand repeated operation performance
Be able to withstand repeated operations for 20 times without damage or
breakage.
4.6 Sterility requirements (applicable to single-use products)
4.6.1 The loop ligature shall be sterile.
4.6.2 Residual ethylene oxide (applicable to products sterilized by ethylene
oxide method): concentration of residual ethylene oxide: 10μg/g or less.
4.7 Luer connector (suitable for loop ligature with injection port)
Shall meet the relevant requirements of GB/T 1962.1-2001 and GB/T 1962.2-
2001.
4.8 Product manual
4.8.1 It shall include a clear description of the endoscope and other medical
equipment that can be used with the loop ligature, so as to allow users to select
appropriate endoscopes and other medical equipment according to this guide.
It is recommended to use the relevant parts of GB/T 16886 for biological tests.
5.1.3 Dissolved matter of ligature ring test
In accordance with Annex A.
5.1.4 Test method for dissolved eluate of polymer materials in the
remaining contact parts
NOTE: Preparation of test solution: prepare according to the eighth method in Table 1 of
GB/T 14233.1-2008.
5.1.4.1 Appearance (turbidity, color): according to the method specified in 5.1
of GB/T 14233.1-2008.
5.1.4.2 pH: according to the method specified in 5.4.1of GB/T 14233.1-2008.
5.1.4.3 Heavy metals: in accordance with the methods specified in 5.6 of GB/T
14233.1-2008.
5.1.4.4 Potassium permanganate reducing substance: according to the method
specified in 5.2 of GB/T 14233.1-2008.
5.1.4.5 Evaporation residue: according to the method specified in 5.5 of GB/T
14233.1-2008.
5.2 Appearance
5.2.1 Hand feel and visual inspection shall meet the requirements of 4.2.1.
5.2.2 Hand feel and visual inspection shall meet the requirements of 4.2.2.
5.2.3 Use fingertips to gently stroke the entire surface of the insertion portion.
There shall be no damage such as crushing, excessive bending.
5.2.4 Hand feel and visual inspection shall meet the requirements of 4.2.4.
5.2.5 Visual comparison shall meet the requirements of 4.2.5.
5.3 Size
5.3.1 Maximum insertion portion width: use a universal measuring tool to
inspect, which shall meet the requirements of 4.3.1.
5.3.2 Working length: use a universal measuring tool to inspect, which shall
meet the requirements of 4.3.2.
5.3.3 Ligature ring opening: use a universal measuring tool to inspect, which
shall meet the requirements of 4.3.3.
Annex A
(normative)
Dissolved matter test
A.1 Purpose
The purpose of this test is to qualitatively and quantitatively analyze the
extractables and other dissolved matters in the tested material under
physiological conditions.
A.2 General
Choose an established and confirmed analytical method that meets the
detection limit of concentration determination.
A.3 Test material
For the sterilized finished product to be tested, the sampling amount is about
2g.
A.4 Control material
Take the blank solvent treated according to A.6.1 and the extraction solution of
the test material for comparison experiment.
A.5 Instruments
NOTE: The following instruments are recommended. Other suitable instruments can also
be used.
A.5.1 Glass bottle (such as borosilicate glass), meets the hydrolysis level I
stipulated by the European Pharmacopoeia and the United States
Pharmacopoeia.
A.5.2 Laboratory glassware.
A.5.3 Syringe.
A.5.4 Analytical balance.
A.5.5 Stirrer.
A.5.6 Incubator.
A.5.7 Centrifuge.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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