ISO 14630:2012 — Non-active surgical implants — General requirements

Specifies general requirements for non-active surgical implants. Covers material requirements, design requirements, manufacturing, sterilization, packaging, labelling, and information supplied by the manufacturer. Serves as the parent standard for specific implant standards (orthopedic, cardiovascular, etc.).

Standard Details

• Standard Number: ISO 14630:2012
• Type: ISO Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/60894.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.