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YY 0334-2002 English PDF (YY0334-2002)

YY 0334-2002 English PDF (YY0334-2002)

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YY 0334-2002: [Including 2013XG] General specification for surgical implants made of silicone elastomer

YY 0334-2002
C 31
General specification for surgical implants
made of silicone elastomer
Issued by. National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Extraneous material ... 6
5 Chemical and biological properties ... 6
6 Sterility ... 8
7 Packaging and marking ... 8
Annex A (Normative) Method for measurement of microelements ... 9
Annex B (Normative) Method for measurement of evaporation residues . 10 Annex C (Normative) pH value test method ... 12
Annex D (Normative) Peroxides test method ... 13
Annex E (Normative) Reducing matters (easily oxidizable substances) test method ... 14
Annex F (Normative) Method for measurement of ultraviolet absorbance of extract of an implant ... 16
Annex G (Normative) Heavy metal determination test method ... 17
Annex H (Informative) Ethylene oxide residues test method ... 18
Bibliography ... 21
General specification for surgical implants
made of silicone elastomer
1 Scope
This Standard specifies general requirements for chemical and biological properties, sterility, packaging and marking of surgical implants consisting solely of silicone elastomer. Specific mechanical and physical properties of implants have not been specified.
These surgical implants are intended for use in orthopaedic and restorative surgery. Implants made of silicone elastomers together with other materials are excluded. 2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.
GB/T 601, Chemical reagent – Preparations of standard volumetric solutions GB/T 16175, Biological evaluation test methods for medical organic silicon materials
GB/T 16886.1, Biological evaluation of medical devices – Part 1. Evaluation and testing
YY/T 0313, Package, label, transport and storage for medical polymer products Pharmacopoeia of the People's Republic of China, 2002 edition
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. 3.1
Annex D
Peroxides test method
D.1 Principle
Residual peroxides are extracted from the implant or sample by treatment with dichloromethane. Sodium iodide is added to the extract at acid pH and the iodine liberated is titrated with sodium thiosulphate, using starch as the indicator. D.2 Reagents
D.2.1 Dichloromethane (of analytical reagent grade).
D.2.2 Freshly prepared sodium thiosulphate (of analytical reagent grade) solution, 0.2 g/L. dissolve 20 g of sodium thiosulphate in 100 mL of glacial acetic acid (of analytical reagent grade).
CAUTION. Glacial acetic acid is corrosive and should be handled with proper precautions.
D.2.3 Standard solution of sodium thiosulphate of analytical reagent grade, c(Na2S2O3) = 0.1 mol/L. prepare and calibrate as specified in 4.6 of GB 601.
D.2.4 Standard solution of sodium thiosulphate, c(Na2S2O3) = 0.01 mol/L. before use, take the sodium thiosulphate standard solution 0.1 mol/L before adding distilled water to dilute for tenfold.
D.2.5 Freshly prepared starch indicator paste.
D.3 Test procedures
Cut the implant or sample into small pieces of less than 10 mm major dimension. Using a balance weigh between 4.8 g and 5.2 g of the sample to an accuracy of ± 0.001 g and record the mass of the sample.
Transfer the sample to a triangular flask; add 150 mL ± 0.1 mL of dichloromethane; stopper the flask; shake for 16 h at room temperature, using a mechanical flask shaker. Filter the contents of the flask immediately through coarse filter paper and collect the filtrate in a flask in which the air is constantly being displaced by the introduction of oxygen-free nitrogen.
Add 1.0 mL of sodium iodide solution; flush the flask with oxygen-free nitrogen; stopper the flask and shake well. Allow the flask to remain for 30 min at room temperature in a

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