General specification for surgical implants made of silicone elastomer
1 Scope
This document specifies the general requirements for chemical and biological properties, sterility, packaging and labeling of surgical implants made of silicone elastomer.
This document is applicable to the testing evaluation of surgical implants made of silicone elastomer.
Note 1: This document does not specify the physical and mechanical properties of implants.
Note 2: For those surgical implants made of silicone elastomer that have been added such as color masterbatch and eikonogen to increase the functionality of the product, the manufacturer may refer to this document based on risk assessment.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions 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 601 Chemical reagent - Preparations of reference titration 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 - Requirements for package and information supplied by manufacturer
Pharmacopoeia of People's Republic of China Edition 2020, Part IV
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
heat-vulcanization; heat-curing
The silicone compound (3.3) is crosslinked into an elastomeric material (silicone elastomer) by heating.
3.2
silicone elastomer
Synthetic elastomer resulted from crosslinking a silicon-reinforced silicone polymer, which consists essentially of repeating diorganosiloxane units.
3.3
silicone compound
Materials made from polysiloxanes mixed with appropriate fillers and crosslinking agents, uncrosslinked.
3.4
silicone, polysiloxane
Its main chain is composed of alternately linked silicon and oxygen atoms, and its side chain contains organic groups.
3.5
post-curing; secondary curing
After vulcanization(curing), a process performed at a certain temperature aimed at enhancing the physical properties of the material and/or removing excess decomposition products.
4 Appearance
For transparent or translucent materials, impurities and other foreign particles shall be free from the outer surface of the silicone elastomer implants via visual inspection at 10 times magnification.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Appearance
5 Requirements
5.1 General
5.2 Biological evaluation
5.3 Material requirements
5.4 Extraction requirements
6 Sterility
7 Packaging and marking
Annex A (Normative) Test method for trace elements
Annex B (Normative) Method of preparation of extracts
Annex C (Normative) Test method for evaporation residue
Annex D (Normative) pH value test method
Annex E (Normative) Peroxide test method
Annex F (Normative) Test method for reducing substances (oxidables)
Annex G (Normative) Ultraviolet absorption test method
Bibliography
