YY/T 0334-2022 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0334-2022 | English | 245 |
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General specification for surgical implants made of silicone elastomer
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| YY 0334-2002 | English | 180 |
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[Including 2013XG] General specification for surgical implants made of silicone elastomer
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YY/T 0334-2022: General specification for surgical implants made of silicone elastomer---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0334-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
CCS C 31
Replacing YY 0334-2002
General Specification for Surgical Implants Made of Silicone
Elastomer
Issued on. AUGUST 17, 2022
Implemented on. SEPTEMBER 1, 2023
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 6
4 Appearance... 7
5 Requirements... 7
6 Sterility... 9
7 Packaging and Marking... 9
Appendix A (normative) Test Method for Trace Elements... 10
Appendix B (normative) Preparation Method for Test Solution... 11
Appendix C (normative) Test Method for Evaporation Residue... 12
Appendix D (normative) Test Method for pH... 13
Appendix E (normative) Test Method for Peroxide... 14
Appendix F (normative) Test Method for Reducing Substances (easily oxidized)... 16
Appendix G (normative) Test Method for Ultraviolet Absorption... 18
Bibliography... 19
1 Scope
This document specifies general requirements for the chemical and biological properties,
sterility, packaging and marking of surgical implants made of silicone elastomer.
This document is applicable to the test and evaluation of surgical implants made of silicone
elastomer.
NOTE 1.this document does not specify specific indicators of the physical and mechanical
properties of the implants.
NOTE 2.for surgical implants made of silicone elastomer that have added color masterbatch and
developer, etc. in order to increase the functionality of the products, the manufacturer
may refer to this document based on risk assessment.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 601 Chemical Reagent - Preparations of Standard Volumetric Solutions
GB/T 14233.1 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 within
a Risk Management Process
YY/T 0313 Medical Polymer Products - Requirement for Package and Information Supplied
by Manufacturer
Pharmacopoeia of the People��s Republic of China (2020) Volume IV
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 heat-vulcanization; heat-curing
Through heating, the silicone compound (3.3) is cross-linked into an elastic material (silicone
elastomer).
3.2 silicone elastomer
A synthetic elastomer obtained by cross-linking silicon-reinforced silicone polymer chains
consisting essentially of repeating diorganosiloxane units.
3.3 silicone compound
A material composed of polysiloxane mixed with suitable fillers and cross-linking agents,
without cross-linking.
3.4 silicone, polysiloxane
A polymer whose main chain is alternately linked by silicon and oxygen atoms, and whose side
chains contain organic groups.
3.5 post-curing; secondary curing
After vulcanization, a process performed at a certain temperature to enhance the physical
properties of the material and / or remove excess decomposition products.
4 Appearance
For transparent or semitransparent materials, under 10 times magnification, visually inspect the
outer surface of the implants made of silicone elastomer, and there shall be no impurities or
other foreign particles.
5 Requirements
5.1 General
The implants made of silicone elastomer shall be tested as supplied. If the implants made of
silicone elastomer have two or more separable different types of silicone elastomer, each type
of silicone elastomer shall be respectively sampled and tested.
5.2 Biological Evaluation
Carry out biological evaluation of the implants made of silicone elastomer in accordance with
GB/T 16886.1.The evaluation results shall have no unacceptable biological hazards.
5.3 Material Requirements
5.3.3 Identification
In accordance with the 0402 infrared spectrophotometry of the Pharmacopoeia of the People��s
Republic of China (2020) Volume IV, carry out the test. The infrared spectrum of the implants
made of silicone elastomer shall be consistent with the standard control spectrum provided by
the manufacturer.
5.4 Requirements for Soluble Substances
5.4.1 Solution appearance
In accordance with B.3, take the filtrate. In accordance with the 0901 solution color inspection
method and the 0902 clarity inspection method in Pharmacopoeia of the People��s Republic of
China (2020) Volume IV, carry out the test. The test solution shall be colorless and clear.
5.4.3 pH
When tested in accordance with Appendix D, the difference in pH value between the test
solution and the blank solution shall not be greater than 1.5.
5.4.4 Catalyst residue
For the peroxide type of implants made of silicone elastomer, when tested in accordance with
Appendix E, the difference in the volume of the sodium thiosulfate standard titration solution
[c (Na2S2O3) = 0.01 mol/L] consumed by the tested solution and the blank solution shall not
exceed 0.2 mL.
5.4.5 Reducing substances (easily oxidized)
When tested in accordance with Appendix F, the difference in the volume of the potassium
permanganate standard titration solution [c(1/5KMnO4) = 0.01 mol/L] consumed by the test
solution and the blank solution shall not exceed 3.0 mL.
5.4.6 Ultraviolet absorption
When tested in accordance with Appendix G, the absorption value in the wavelength range of
220 nm ~ 340 nm shall not exceed 0.4.
5.4.7 Heavy metals
In accordance with B.3, take the filtrate. When tested in accordance with GB/T 14233.1, the
heavy metal contents shall not exceed 1 mg/L.
6 Sterility
The surgical implants made of silicone elastomer shall undergo a validated sterilization process.
If ethylene oxide is used for sterilization, the residual amount of ethylene oxide for the
sterilization of the implants made of silicone elastomer shall be controlled.
7 Packaging and Marking
The packaging and marking of the surgical implants made of silicone elastomer shall comply
with the relevant stipulations of YY/T 0313.Permanent surgical implants shall be uniquely and
traceably identified.
Appendix A
(normative)
Test Method for Trace Elements
A.1 Principle
The sample is digested in a sealed mode through nitric acid and hydrofluoric acid to prepare a
specimen solution. Use atomic absorption spectrophotometry or inductively coupled plasma
atomic emission spectrometry or inductively coupled plasma mass spectrometry to directly
determine the contents of arsenic, cadmium, lead, chromium, iron and platinum.
A.2 Preparation of Reagents and Solutions
A.2.1 Standard solutions of arsenic, cadmium lead, chromium, iron and platinum. in accordance
with the above-mentioned conventional methods, respectively prepare stock solutions
containing 1 mg/mL of arsenic, cadmium, lead, chromium, iron and platinum. Before use, use
nitric acid solution with a volume fraction of 1% to dilute to the required concentration.
A.2.2 Nitric acid. superior-grade purity.
A.3 Preparation of Test Solution
Accurately weigh-take 1.0 g of the sample, place it in a polytetrafluoroethylene cup, add 5 mL
of nitric acid and 5 mL of hydrofluoric acid, cover and seal it; tighten the stainless-steel sheath
and heat it in the oven at 160 C for 2 hours; take it out and let it cool to room temperature.
Take out the polytetrafluoroethylene cup, and heat it uncovered on an electric hot plate at low
temperature, until it approaches almost dryness. Along the wall of the cup, add 0.5 mL of nitric
acid, evaporate again to nearly dryness. Add 5 mL of nitric acid with a volume fraction of 1%,
heat it to nearly boiling, and let it cool. Use a polyethylene tube to absorb the solution, transfer
the solution into a 25 mL volumetric flask. Use nitric acid with a volume fraction of 1% to wash
the polytetrafluorethylene cup several times, put the washing solution into a volumetric flask,
and use nitric acid with a volume fraction of 1% to dilute it to the scale.
The microwave digestion method can also be used to prepare the test solution.
A.4 Test Method
In accordance with the 0406 atomic absorption spectrophotometry or the 0411 inductively
coupled plasma atomic emission spectrometry or the 0412 inductively coupled plasma mass
spectrometry in Pharmacopoeia of the People��s Republic of China (2020) Volume IV, determine
the digested solution.
Appendix B
(normative)
Preparation Method for Test Solution
B.1 Reagents
B.1.1 Distilled or deionized water.
B.1.2 n-hexane (analytically pure).
B.2 Instruments
B.2.1 Reflux device made of borosilicate glass, with a capacity of 250 mL ~ 500 mL.
B.2.2 Vacuum filtration device (including borosilicate sand core filtration device, 0.45 m
aqueous filter membrane and vacuum filtration pump).
B.2.3 Analytical balance (accurate to 0.01 g).
B.3 Distilled Water Extraction
Cut the sample into pieces smaller than 10 mm, use a balance to weigh 12.50 g 0.25 g of
sample, accurate to 0.01 g, and record the sample mass. Place the sample in a reflux device,
add 250 mL of distilled water or deionized water, and heat to reflux for 5 hours.
After stopping heating, cool the reflux device and immediately use a vacuum filtration device
to filter it. If the filtrate needs to be placed, place it in a covered borosilicate container.
B.4 n-hexane Extraction
Cut the sample into pieces smaller than 5 mm, use a balance to weigh 5.00 g 0.50 g of sample,
accurate to 0.01 g, and record the sample mass. Place the sample in a reflux device, add 250
mL of n-hexane, and heat to reflux for 4 hours.
After stopping heating, cool the reflux device and immediately use a vacuum filtration device
to filter it. If the filtrate needs to be placed, place it in a covered borosilicate container.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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