Overview
ISO 14607:2018 - "Non-active surgical implants - Mammary implants - Particular requirements" is a level‑2 ISO standard that specifies safety‑related requirements specific to mammary (breast) implants. It complements the general requirements for non‑active surgical implants by defining detailed expectations for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and the information manufacturers must supply.
This third edition (2018) updates material characterization and test methods (for example, trace element limits and silicone constituents) and adds/updates several normative annexes for mechanical, chemical and biological evaluation.
Key topics and technical requirements
ISO 14607:2018 addresses the following technical topics:
- Intended performance and design attributes
- Definitions for anterior projection, base dimensions and filling volume for inflatable/adjustable implants.
- Materials and biocompatibility
- Material documentation, physico‑mechanical characterization, cytotoxicity, residual oligomers and trace element limits.
- Normative testing for silicone constituents (Annex A: determination of D4 and D5).
- Design evaluation
- Pre‑clinical testing: mechanical tests (fatigue, shell integrity), physical and chemical characterization, biological evaluation in accordance with ISO 10993 series.
- Clinical evaluation and post‑market surveillance requirements.
- Manufacturing, sterilization and packaging
- Requirements for production controls, validated sterilization and sterile barrier systems.
- Information supplied by the manufacturer
- Labelling, user information (including resterilization and diagnostic effects), marking on implants, filling materials, expected lifetime, and patient information/records.
- Test methods and annexes
- Normative annexes include shell integrity, mechanical tests on implanted state, valve competence, gel cohesion and penetration, silicone diffusion assessment, and surface characteristics.
Practical applications and who uses this standard
ISO 14607:2018 is used by:
- Medical device manufacturers - product design, material selection, test programs, regulatory submissions and labeling.
- Regulatory and quality affairs teams - to demonstrate conformity with specific requirements for mammary implants during CE marking or other approvals.
- Testing laboratories and contract research organizations - to perform the standardized mechanical, chemical and biological tests referenced in the annexes.
- Notified bodies and auditors - assessing compliance with applicable standards and evaluating technical documentation.
- Clinicians and procurement specialists - understanding device claims, labeling and expected lifetime information.
Using ISO 14607 together with level‑1 general requirements (ISO 14630) and biological/clinical standards (ISO 10993 series, ISO 14155) helps ensure comprehensive safety, performance and regulatory compliance for mammary implants.
Related standards
- ISO 14630 - Non‑active surgical implants: General requirements
- ISO 10993‑1, ‑5, ‑18 - Biological evaluation and chemical characterization
- ISO 11607 - Packaging for terminally sterilized medical devices
- ISO 14155 - Clinical investigation of medical devices (good clinical practice)
