Overview
SIST EN ISO 14607:2025 - titled Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024) - specifies safety and performance requirements for mammary (breast) implants. Adopted by CEN as EN ISO 14607:2025 and replacing the 2018 edition, this standard addresses intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and the information supplied by the manufacturer. It is intended to support conformity with Regulation (EU) 2017/745 where applicable.
Key topics and technical requirements
The standard focuses on technical topics that determine implant safety and performance, including:
- Intended performance and design attributes - definition of functional requirements specific to mammary implants.
- Materials and biocompatibility - requirements for silicone gel and shell materials with emphasis on:
- Cytotoxicity and biological evaluation within a risk management process (references to ISO 10993 series).
- Residual low molecular weight silicone oligomers and confirmation of material specifications.
- Trace elements (impurities and intentionally added elements) and limits for safety assessment.
- Design evaluation and mechanical integrity - tests and criteria for shell integrity, fatigue, impact resistance, cohesion and endurance (see Annexes B, C, E).
- Silicone gel properties - cohesion, penetration and surface classification tests (Annexes E, F, G).
- Manufacturing, sterilization and packaging - sterile barrier and packaging requirements aligned with ISO 11607; processes to ensure consistent product quality.
- Information supplied by the manufacturer - labeling, risk information and patient/clinician instructions consistent with ISO 20417 and regulatory expectations.
- Risk management and clinical considerations - linkage to ISO 14971 for risk control and ISO 14155 for clinical investigation where applicable.
Practical applications - who uses this standard
SIST EN ISO 14607:2025 is used by:
- Breast implant manufacturers for design controls, material selection and product specifications.
- Quality and regulatory affairs teams to demonstrate conformity with MDR (EU) 2017/745 and harmonized requirements.
- Notified bodies and conformity assessment organizations when assessing device dossiers and test evidence.
- Testing and contract laboratories performing mechanical, chemical and biological tests referenced by the standard.
- Packaging and sterilization engineers, and clinical researchers conducting pre‑clinical and clinical evaluations.
Related standards (normative references)
Key referenced standards include:
SIST EN ISO 14607:2025 is essential for stakeholders seeking clear technical requirements for safe design, testing and market conformity of mammary implants. Keywords: SIST EN ISO 14607:2025, mammary implants, breast implants, silicone gel, implant design, sterilization, biocompatibility, EU MDR.
