Your needs: check that your breast implants comply with the ISO 14607 standard
ISO 14607 in the medical industry
The ISO 14607 standard relates to breast implants and defines specific requirements for this type of medical device.
Its scope covers silicone gel-filled breast implants, whether pre-filled at the factory or filled at the time of surgery, used in reconstructive or aesthetic procedures.
ISO 14607 is one of a series of standards governing implantable medical devices. It complements ISO 14630, which defines the general requirements applicable to non-active implantable medical devices.
The objectives of ISO 14607
The ISO 14607 standard details a set of precise technical requirements relating to the quality, safety and performance of silicone-based breast implants. In particular, it deals with the materials used, focusing on the composition of the silicone gel and its outer shell.
It also defines the mechanical properties to be verified, such as tensile strength, fatigue and gel retention capacity. Rigorous tests are prescribed to assess gel cohesion, potential substance leakage, envelope integrity and accelerated ageing of the device.
Finally, the standard specifies requirements for sterilisation, packaging and labelling, to ensure complete control of the product right through to its final use.
FILAB supports manufacturers in the analysis of particulate contamination in accordance with the ISO 14607 standard
Why choose FILAB for particle contamination analysis according to ISO 14607?
FILAB, a laboratory made up of experts in the analysis of materials intended for medical use, offers you its analytical services, from the design to the manufacture and implementation of a product meeting the ISO 14607 standard.
Particle contamination analysis methods in accordance with ISO 14607
The ISO 14607:2018 standard for silicone-based breast implants includes an essential requirement for particle purity, in line with the safety requirements for implantable devices.
The purpose of particle counting is to ensure the absence of contamination by undesirable particles (organic, inorganic, metallic, etc.), which may come from the materials, the manufacturing process or the environment.
ISO 14607 does not prescribe a single particle counting method, but requires that the analysis be carried out in a traceable, documented and justifiable manner, often based on other standards such as :
USP 788 for injectable products (particle counting)
Analysis methods for particulate contamination in accordance with ISO 14607
Technical resources
Nos prestations annexes
