ISO 14607-2024 PDF

Full title and description

ISO 14607:2024 — Non‑active surgical implants — Mammary implants — Specific requirements. This International Standard specifies safety‑related requirements for the design, materials, manufacture, packaging, sterilization and information supplied by the manufacturer for mammary (breast) implants.

Abstract

This document sets out particular requirements for mammary implants to ensure their intended performance and safety. It covers design attributes, material selection and evaluation, manufacturing controls, packaging and sterilization, and the information that must accompany the product (labelling and instructions for use).

General information

• Status: Published.
• Publication date: 2 December 2024.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Edition 4 (2024).
• Number of pages: 53.

Scope

ISO 14607:2024 specifies particular (level‑3) requirements that apply to mammary implants. In the interest of patient safety it addresses intended performance, design attributes, material and biocompatibility considerations, design evaluation (including pre‑clinical and clinical evidence as applicable), manufacturing and process control, packaging integrity and sterility assurance, and the labelling and information that manufacturers must supply to users. The standard is intended to be used alongside general (level‑2) and other applicable standards for medical implants.

Key topics and requirements

• Intended performance and design requirements for mammary implants (shape, volume, mechanical strength, durability).
• Material selection and characterization, with attention to biocompatibility and degradation products.
• Design evaluation and verification (bench testing, aging, mechanical tests and where applicable pre‑clinical/clinical data).
• Manufacturing controls, traceability and process validation.
• Sterilization methods, validation and residuals control.
• Packaging integrity, labelling, and instructions for safe use and implantation.
• Risk management and post‑market surveillance expectations (integration with device risk processes).

These topics reflect the standard’s focus on ensuring mammary implant safety and performance throughout the product life cycle.

Typical use and users

Primary users are manufacturers and designers of mammary implants, conformity assessment and test laboratories, notified bodies / regulators and quality teams responsible for medical device compliance. Clinicians, hospitals and procurement specialists may consult the standard for product requirements and labelling expectations. Standards writers and regulatory authorities use ISO 14607 together with general implant standards and biocompatibility, sterilization and risk management standards when assessing conformity.

Related standards

Relevant companion and referenced standards commonly used with ISO 14607: ISO 14630 (Non‑active surgical implants — General requirements) for level‑2 general rules; ISO 10993 series for biological evaluation/biocompatibility; ISO 14971 for medical device risk management; ISO 13485 for quality management systems in medical device manufacture; ISO 22442 series where animal‑derived materials are used. ISO 14607:2024 supersedes ISO 14607:2018.

Keywords

ISO 14607, mammary implants, breast implants, non‑active surgical implants, implant requirements, biocompatibility, sterilization, packaging, ISO/TC 150, medical device standards.

FAQ

Q: What is this standard?

A: ISO 14607:2024 is an International Standard that provides specific (particular) requirements for mammary (breast) implants to ensure their safety and intended performance.

Q: What does it cover?

A: It covers intended performance and design attributes, material and biocompatibility considerations, design verification and evaluation, manufacturing and process controls, packaging and sterilization, labelling and information supplied by the manufacturer, and requirements to support product safety across the life cycle.

Q: Who typically uses it?

A: Manufacturers and designers of mammary implants, test laboratories, conformity assessment bodies, regulators, quality and regulatory affairs teams, plus clinicians and procurement officers who need to understand product requirements.

Q: Is it current or superseded?

A: ISO 14607:2024 is the current published edition (Edition 4, published 2 December 2024). It replaces ISO 14607:2018.

Q: Is it part of a series?

A: Yes — it is a level‑3 (specific) standard for a particular implant type and is intended to be used with level‑2 general implant standards (for example ISO 14630) and other cross‑cutting standards such as the ISO 10993 biocompatibility series and ISO 14971 for risk management.

Q: What are the key keywords?

A: Mammary implants; breast implants; non‑active surgical implants; biocompatibility; sterilization; packaging; design evaluation; ISO 14607.