This standard specifies requirements for two-component addition-curing organic silicone elastomers used in surgical implants. It includes detailed information on material composition, physical properties, and testing methods to ensure the safety and efficacy of these materials when used in medical devices. The document aims to provide a framework for manufacturers and healthcare providers to assess the quality and reliability of organic silicone elastomers utilized in surgical procedures.
*** Please note: This description may not be accurate, please refer to the official documentation.
KS P ISO 14949-2019 history
2024KS P ISO 14949-2024 Implants for surgery－Two-part addition-cure silicone elastomers
2019KS P ISO 14949-2019 Implants for surgery－Two-part addition-cure silicone elastomers
2009KS P ISO 14949:2009 Implants for surgery－Two-part addition-cure silicone elastomers