YY/T 0931-2014Medical endoscopes—Endotherapy device—Loop ligature (English PDF)
医用内窥镜 内窥镜器械 圈形套扎装置
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0931-2014 is the English-translated version of 医用内窥镜 内窥镜器械 圈形套扎装置.
YY/T 0931-2014 is the Chinese pharmaceutical industry standard for the loop ligature, the endotherapy device with which a polyp or a pedicle is tied off through an endoscope.
It specifies the terms and definitions, the requirements and the test methods, covering the dimensions of the loop and of the sheath, the tensile strength of the ligature and of the knot, the closing force and the release of the loop, the materials and their biological evaluation and sterility. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0931-2014
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions4
- 4 Requirements5
- 5 Test methods9
- 6 Inspection rules12
- Annex A (normative) Dissolved matter test No. 1 Amendment 2020XG113
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 Requirements
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
4.1.4.4 Potassium permanganate reducing substance: the difference from the consumption of the standard test solution is less than 2.0mL.
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.
4.1.4.3 Heavy metals: dissolved matter is below 5.0µg/mL
4.1.4.1 Appearance (turbidity
color): colorless and transparent, no foreign matter can be detected by visual inspection.
4.1.4.2 pH
The pH difference is below 2.0.
4.1.4.5 Evaporation residue: less than 2.0mg
4.2 Appearance
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 Test methods
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.
5.1.4.3 Heavy metals: in accordance with the methods specified in 5.6 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.
5.1.4.2 pH: according to the method specified in 5.4.1of 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.
5.2 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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.1-2001Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- GB/T 1962.2-2001Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.1-2011Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0149-2006Medical instruments of stainless steel - Test methods of corrosion resistance
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Related Standards
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 1962.2-2001 — Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
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