YY/T 1555.2-2018 (YY/T1555.2-2018, YYT 1555.2-2018, YYT1555.2-2018)
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Particular requirements for the silicone gel filled breast implant. Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances
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YY/T 1555.2-2018
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Preview PDF: YY/T 1555.2-2018
| Standard ID | YY/T 1555.2-2018 (YY/T1555.2-2018) | | Description (Translated English) | Particular requirements for the silicone gel filled breast implant. Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 9,998 | | Date of Issue | 2018-12-20 | | Date of Implementation | 2020-01-01 | | Quoted Standard | YY 0334-2002; YY/T 1457 | | Drafting Organization | China Institute of Food and Drug test | | Administrative Organization | National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices | | Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the extraction method, detection method and limit requirements for extractable substances in silicone gel fillings for artificial breast implants. This standard applies to artificial breast implants with silicone gel as the inner filling. |
YY/T 1555.2-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 30
Particular requirements for the silicone gel filled
breast implant - Performance requirement of silicone
gel filler - Part 2: Limits requirement for extractable
substances
ISSUED ON: DECEMBER 20, 2018
IMPLEMENTED ON: JANUARY 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Limit requirements ... 5
5 Detection methods ... 6
Appendix A (Normative) Preparation method of extract ... 7
Appendix B (Normative) Determination of residual amount of oligosiloxane
substances: gas chromatography (GC method) ... 8
Bibliography ... 11
Particular requirements for the silicone gel filled
breast implant - Performance requirement of silicone
gel filler - Part 2: Limits requirement for extractable
substances
1 Scope
This Part of YY/T 1555 specifies the extraction methods, detection methods and
limit requirements for extractable substances in the silicone gel filler used for
artificial mammary implant.
This Part applies to artificial mammary implants with silicone gel as the inner
filler.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
Standard.
YY 0334-2002, General specification for surgical implants made of silicone
elastomer
YY/T 1457, Non-active surgical implants - Determination method for
oligomeric siloxanes in mammary implants
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
mammary implant
An implant with a shell, which is used for increasing the volume of the breast or
replacing the breast. The shell can be filled with objects by a manufacturer or a
surgeon.
[YY 0647-2008, definition 3.5]
3.2
filler
The contents of the implant.
Appendix B
(Normative)
Determination of residual amount of oligosiloxane substances: gas
chromatography (GC method)
B.1 Principle
Use gas chromatography to analyze the small molecules in the extract. When
the vaporized sample is carried by the mobile phase into the chromatographic
column for operation, it is repeatedly distributed between the two phases. Due
to the different distribution coefficients of each component between the mobile
phase and the stationary phase, the running speed of each component in the
chromatographic column is different. After a certain column length, they are
separated from each other. They leave the chromatographic column and enters
the detector in sequence. The detector can convert the sample component
information into an electrical signal; the size of the electrical signal is
proportional to the amount or concentration of the measured component, so as
to realize the detection of the measured component.
B.2 Apparatus
B.2.1 Gas chromatograph, with hydrogen flame ionization detector.
B.2.2 Electronic balance (precision of 0.1 mg).
B.2.3 Ultrasonic cleaner.
B.3 Reagents
B.3.1 Acetone, required to be analytical grade and above.
B.3.2 Octamethylcyclotetrasiloxane (D4), required to be analytical grade and
above.
B.3.3 Decamethylcyclopentasiloxane (D5), required to be analytical grade and
above.
B.4 Test methods
B.4.1 Standard solution preparation
Take about 0.05 g of D4, D5 and other oligosiloxane substances respectively;
accurately weigh them; use acetone to dilute the solution to 50 mL; then, use
acetone to dilute the solutions successively, to prepare mixed standard
solutions of D4 and D5 oligosiloxane substances of at least 5 concentration
gradients from 1 μg/mL to 50 μg/mL.
B.4.2 Gas phase determination
Chromatographic conditions:
Chromatographic column: capillary column (30 m × 0.25 mm × 0.25 μm) with
5% phenyl-95% polydimethylsiloxane as the fixed liquid;
Column temperature: 60 °C (hold for 3 min), raise to 300 °C at 10 °C/min (hold
for 10 min);
Inlet temperature: 280 °C;
Detector temperature: 300 °C;
Carrier gas: helium or nitrogen (purity above 99.99%), flow rate of 1.0 mL/min;
Injection volume: 1 μL.
Take the blank solution, standard solution, and sample solution (see A.3 for the
preparation method) for the gas chromatograph test. Take a standard solution
of an intermediate concentration and inject consecutively 5 times, to calculate
the relative standard deviation (RSD) of the peak area of oligosiloxane
substances.
B.5 Result analysis
B.5.1 Use the external standard method to analyze the test results; establish a
standard working curve and a regression equation; calculate the residual
amount of oligosiloxane substances in the sample according to Formula (B.1).
The measurement results are expressed as the ratio of the mass (μg) of
oligosiloxane substances to the mass (g) of the test mass; the unit is μg/g,
namely, mg/kg.
Where:
X – the residual amount of oligosiloxane substances, in micrograms per gram
(μg/g, namely, mg/kg);
c – the concentration value of oligosiloxane substances in the sample test
solution, which is read on the standard curve, in micrograms per milliliter
(μg/mL);
V – the volume of the added extraction solvent acetone, in milliliters (mL);
m – the mass of the sample, in grams (g).
B.5.2 If the concentration value read on the standard curve is less than the
minimum concentration value of the standard solution, the result is expressed
by Formula (B.2):
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