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 made of silicone elastomer. It does not specify specific indicators of the mechanical and physical properties of them.
These implants are mainly intended for use in orthopaedic and restorative surgery. Surgical implants made of silicone rubber together with other materials are not included in the scope of this standard.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions of, any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
GB 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 within a risk management process
YY/T 0313 Package, label, transport and storage for medical polymer products
Pharmacopoeia of the People’s Republic of China (2000 Edition)
3 Definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
heat-vulcanization, heat-curing
process of converting a silicone compound to an elastomeric material (silicone elastomer) by crosslinking under the influence of heat
3.2
silicone elastomer
rubber-like material derived from a silicone compound that has been crosslinked or heat vulcanized and, where applicable, post-cured
3.3
silicone compound
material made from silicone that has been compounded with suitable fillers and crosslinking agents, prior to crosslinking
3.4
silicone, polysiloxane
polymer in which the main chain consists of alternating silicon and oxygen atoms with organic side groups
3.5
post-curing, secondary curing
process of curing, following crosslinking, carried out under controlled temperatures and intended to enhance the physical properties of the material and/or remove unwanted decomposition products
4 Extraneous material
When examined visually under x10 magnification, the surface of the implant shall be free from grit and other extraneous particles.
Foreword i Introduction ii 1 Scope 2 Normative References 3 Definitions 4 Extraneous material 5 Chemical and biological properties 6 Sterility 7 Packaging and marking Annex A (Normative) Method of measurement of trace element constituents Annex B (Normative) Method of measurement of residue on evaporation Annex C (Normative) Method of measurement of pH Annex D (Normative) Method of measurement of peroxide Annex E (Normative) Method of measurement of reducing substance (easily-oxidized substance) Annex F (Normative) Method of measurement of sample extracts ultraviolet absorbance Annex G (Normative) Method of measurement of heavy metals Annex H (Informative) Method of measurement of ethylene oxide residue Bibliography
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 made of silicone elastomer. It does not specify specific indicators of the mechanical and physical properties of them.
These implants are mainly intended for use in orthopaedic and restorative surgery. Surgical implants made of silicone rubber together with other materials are not included in the scope of this standard.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions of, any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
GB 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 within a risk management process
YY/T 0313 Package, label, transport and storage for medical polymer products
Pharmacopoeia of the People’s Republic of China (2000 Edition)
3 Definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
heat-vulcanization, heat-curing
process of converting a silicone compound to an elastomeric material (silicone elastomer) by crosslinking under the influence of heat
3.2
silicone elastomer
rubber-like material derived from a silicone compound that has been crosslinked or heat vulcanized and, where applicable, post-cured
3.3
silicone compound
material made from silicone that has been compounded with suitable fillers and crosslinking agents, prior to crosslinking
3.4
silicone, polysiloxane
polymer in which the main chain consists of alternating silicon and oxygen atoms with organic side groups
3.5
post-curing, secondary curing
process of curing, following crosslinking, carried out under controlled temperatures and intended to enhance the physical properties of the material and/or remove unwanted decomposition products
4 Extraneous material
When examined visually under x10 magnification, the surface of the implant shall be free from grit and other extraneous particles.
Contents of YY 0334-2002/XG1-2013
Foreword i
Introduction ii
1 Scope
2 Normative References
3 Definitions
4 Extraneous material
5 Chemical and biological properties
6 Sterility
7 Packaging and marking
Annex A (Normative) Method of measurement of trace element constituents
Annex B (Normative) Method of measurement of residue on evaporation
Annex C (Normative) Method of measurement of pH
Annex D (Normative) Method of measurement of peroxide
Annex E (Normative) Method of measurement of reducing substance (easily-oxidized substance)
Annex F (Normative) Method of measurement of sample extracts ultraviolet absorbance
Annex G (Normative) Method of measurement of heavy metals
Annex H (Informative) Method of measurement of ethylene oxide residue
Bibliography
