YY/T 0334-2022 PDF English
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(General requirements for silicone rubber surgical implants)
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[Including 2013XG] General specification for surgical implants made of silicone elastomer
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YY/T 0334-2022: PDF in English (YYT 0334-2022) YY/T 0334-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
General Specification for Surgical Implants Made of Silicone
Elastomer
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. Most of the analysis methods
provided in Chapter 5 are non-specific analysis methods, which may be used to preliminarily
evaluate the chemical hazards of medical devices. However, if non-compliance with this
document occurs in a specific test, it does not mean that the risk brought by the disqualified
item is unacceptable, and specific analysis methods need to be adopted to identify and evaluate
the safety.
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
5.3.1 Weight loss on drying
Take a sample with a mass of no less than 1.0 g, add it to a weighing bottle that has been pre-
dried to a constant mass at 200 C. After heating for 4 hours at 200 C, cool it to room
temperature, then, weigh and calculate the weight loss, which shall be not greater than 2.0%.
5.3.2 Trace elements
When tested in accordance with Appendix A, the trace element contents of the implants made
of silicone elastomer shall comply with lead (Pb) 5 mg/kg, cadmium (Cd) 5 mg/kg, arsenic
(As) 5 mg/kg, chromium (Cr) 10 mg/kg and iron (Fe) 10 mg/kg.
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.
5.4.2 Evaporation residues
When tested in accordance with Appendix C, the evaporation residues of the test solution shall
be 3.0%.
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.
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.2.3 Hydrofluoric 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.
Appendix E
(normative)
Test Method for Peroxide
E.1 Principle
After the peroxide in the sample is leached through dichloromethane, add sodium iodide under
acidic conditions. The displaced iodide ions are titrated by sodium thiosulfate using starch as
an indicator.
E.2 Reagents
E.2.1 Dichloromethane (analytically pure).
E.2.2 Newly prepared sodium iodide (analytically pure) solution (200 g/L): dissolve 20 g of
sodium iodide in 100 mL of glacial acetic acid (analytically pure).
NOTE: glacial acetic acid is a strong corrosive, which shall be handled with appropriate
protection during operation.
E.2.3 Sodium thiosulfate standard titration solution [c(Na2S2O3) = 0.1 mol/L]: in accordance
with the method in GB/T 601, prepare and calibrate it.
E.2.4 Sodium thiosulfate standard titration solution [c(Na2S2O3) = 0.01 mol/L]: before use, take
the sodium thiosulfate standard titration solution [c(Na2S2O3) = 0.1 mol/L] and use freshly
boiled and cooled water to dilute it by 10 times.
E.2.5 Starch indicator solution: take 0.5 g of starch and dissolve it in 100 mL of water, heat to
boil, then, cool it and set aside.
E.3 Test Procedures
Cut the sample into pieces smaller than 10 mm, use a balance to weigh 5.00 g 0.20 g of sample,
accurate to 0.01 g, and record the sample mass. Place the sample into a conical flask, add
150.0 mL 0.1 mL of methylene dichloride, with a stopper. Use a mechanical oscillator to
shake it at room temperature for 16 hours. Then, use a filter paper to filter it, collect the filtrate
into a flask, and continuously replace the air with oxygen-free nitrogen in the flask. Add 1.0
mL of sodium iodide solution, use oxygen-free nitrogen to clear the air in the flask, with a
stopper; shake it well, and place it at room temperature and in the dark for 30 minutes. Add 50.0
mL of distilled water or deionized water, mix it well, and use the sodium thiosulfate standard
titration solution [c(Na2S2O3) = 0.01 mol/L] to titrate it. Use starch as the indicator solution and
record the volume of the sodium thiosulfate standard titration solution required to reach the end
point, accurate to 0.025 mL.
Follow the above-mentioned steps, but do not add a sample, perform a blank determination.
Appendix F
(normative)
Test Method for Reducing Substances (easily oxidized)
F.1 Principle
When the reducing substances contained in the water extract are heated under acidic conditions,
they are oxidized by potassium permanganate. The excess potassium permanganate oxidizes
potassium iodide into iodine, and the iodine is reduced by sodium thiosulfate.
F.2 Preparation of Solutions
Dilute sulfuric acid: measure-take 54 mL of sulfuric acid, slowly pour into 500 mL of water,
cool and dilute to 1,000 mL.
Potassium permanganate standard titration solution [c(1/5KMnO4) = 0.1 mol/L]: in accordance
with the method in GB/T 601, prepare and calibrate it.
Potassium permanganate standard titration solution [c(1/5KMnO4) = 0.01 mol/L]: before use,
take the potassium permanganate standard titration solution [c(1/5KMnO4) = 0.1 mol/L] and
add water to dilute it by 10 times. If necessary, boil, cool and filter it, then calibrate the
concentration.
Sodium thiosulfate standard titration solution [c(Na2S2O3) = 0.1mol/L]: see E.2.3.
Sodium thiosulfate standard titration solution [c(Na2S2O3) = 0.01mol/L]: see E.2.4.
Starch indicator solution: see E.2.5.
F.3 Test Procedures
Take 10 mL of the B.3 filtrate, add it to a 250 mL of iodine flask, add 1 mL of dilute sulfuric
acid and 10 mL of potassium permanganate standard titration solution [c(1/5KMnO4) = 0.01
mol/L]; boil it for 3 minutes, and quickly cool it. Add 0.1 g of potassium iodide, with a stopper,
and shake it well. Immediately use sodium thiosulfate standard solution of the same
concentration to titrate it, until it turns light yellow. Then, add 0.25 mL of starch indicator
solution, and continue to use the sodium thiosulfate standard solution for titration, until it
becomes colorless.
Use the same method to titrate the blank control solution.
F.4 Result Calculation
The content of reducing substances (easily oxidized) is expressed by the amount of potassium
permanganate solution consumed, and calculate in accordance with Formula (F.1):
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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