--- type: "WebPage" title: "Analysis of particulate contamination in accordance with ISO 14607" description: "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..." resource: "https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/analysis-particulate-contamination-iso-14607/" tags: ["EN", "pll_683d977618527"] timestamp: "2026-01-26T09:17:38Z" published: "2025-06-02T13:28:28Z" language: "en" author: "Laure Durieux" --- # Analysis of particulate contamination in accordance with ISO 14607 ## 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](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md). 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](https://filab.fr/en/our-services/our-expertise-services/mechanical-laboratory-test/tensile-test-materials-laboratory.md) strength, [fatigue](https://filab.fr/en/our-services/our-expertise-services/mechanical-laboratory-test/endurance-test-fatigue-testing.md) and gel retention capacity. Rigorous tests are prescribed to assess gel cohesion, potential substance leakage, envelope integrity and [accelerated ageing](https://filab.fr/en/our-services/our-analysis-services/polymer-materials-analysis-laboratory/laboratory-material-testing/filab-accelerated-ageing-test-laboratory/) 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](https://filab.fr/en/our-services/our-analysis-services/polymer-materials-analysis-laboratory/laboratory-material-testing/) 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](https://filab.fr/en/our-services/our-analysis-services/polymer-materials-analysis-laboratory/laboratory-analysis-silicone.md)-based breast implants includes an essential requirement for **particle purity**, in line with the safety requirements for implantable devices. The purpose of [particle counting](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-for-medical-devices.md) 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 t**raceable, documented and justifiable** manner, often based on other standards such as : [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md) for injectable products (particle counting) [AAMI TIR42](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard.md) [ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) [PE 2.9.19](https://filab.fr/nos-prestations/expertise/analyse-particule-vaccin-injectable/labo-comptage-particulaire-pharmacopee-europeenne.md) (method) ### Analysis methods for particulate contamination in accordance with ISO 14607 ISO 14607 ## Technical resources Optical Microscope ([OM](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md)) Scanning Electron Microscope ([SEM](https://filab.fr/en/our-technical-resources/laboratory-analysis-sem-scanning-electron-microscopy.md)) [ยต-IRTF](https://filab.fr/en/our-technical-resources/laboratory-analysis-ftir-microscopy.md) [Raman microscopy](https://filab.fr/en/our-technical-resources/raman-microscopy-analysis-laboratory.md) ## Nos prestations annexes ## [Training in particle counting (USP 788, PE 2.9.19, ISO 16232, etc.)](https://filab.fr/en/our-services/rd/laboratory-analytical-chemistry-training/training-particle-counting.md) [Particle counting in accordance with EP 2.9.19](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-laboratory-according-to-ep-2-9-19.md) [Analysis of particulate contamination in injectables](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/analysis-of-particulate-contamination-in-injectables-2.md) [Analysis of cleaning residues in accordance with ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) Biocompatibility tests in accordance with ISO 10993 standards: [10993-18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md), [10993-12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md), [10993-13](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md), [10993-14](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md), [10993-15](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/study-of-degradation-products-in-your-medical-devices-according-to-iso-10993-15.md), [10993-22](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md)