ISO 5092:2025

Overview

ISO 5092:2025 - "Additive manufacturing for medical - General principles - Additive manufacturing of non-active implants" provides high‑level guidance on factors that affect the safety and performance of surgical implants manufactured by additive manufacturing (AM). It applies to non‑active implants, including custom‑made and patient‑matched implants, and to instrumentation used with those implants. The standard highlights AM‑specific considerations not always covered in implant‑specific standards and excludes implants containing human or animal tissues or cells.

Key Topics

• Relevance of AM techniques - describes AM categories, material options (metals, polymers, ceramics, composites) and AM capabilities (complex lattices, multimaterial printing, in‑situ alloying).
• Risk analysis dedicated to AM implants - identifies AM‑specific risk factors and the need to document processes for:
  • Data processing (design files, slicing, digital workflows)
  • Feedstock material (characteristics, virgin vs reused feedstock)
  • AM process and post‑processing (build strategy, supports, heat treatment, surface finishing)
  • Cleanliness and sterilization (residual powder, porosity, bioburden control)
• Materials - guidance on feedstock characteristics and reuse considerations.
• Design for AM implants - design inputs and constraints unique to AM (e.g., lattice structures, support removal).
• Qualification and validation of AM processes - requirements for process qualification, validation and documentation to meet intended performance.
• Normative references - integrates existing standards (e.g., ISO 14630, ISO 14971, ISO/ASTM 52900 series) for risk management and AM fundamentals.

Applications

Who uses ISO 5092:2025 and how:

• Implant manufacturers & AM process engineers - to develop, qualify and validate AM production lines for non‑active implants and associated instrumentation.
• Designers & clinical engineers - to design patient‑matched and custom implants with AM‑specific constraints and performance considerations.
• Quality and regulatory teams - to perform risk analysis, document feedstock and process controls, and align with ISO 13485 and ISO 14971 requirements.
• Standards developers & regulators - as guidance when drafting implant‑specific AM requirements or assessing conformity.

Practical benefits include improved traceability of feedstock and digital data, reduced implant failure risk from AM‑specific defects (e.g., powder contamination, unexpected porosity), and a structured approach to sterilization and post‑processing planning.

Related Standards (selected)

• ISO 14630, ISO 14971
• ISO/ASTM 52900, 52904, 52920; ISO/ASTM TS 52930, TS 52949
• ASTM F3604; ISO/ASTM 52954‑1; ISO 17296‑2

Keywords: ISO 5092:2025, additive manufacturing, AM, non‑active implants, custom‑made implants, patient‑matched implants, risk analysis, feedstock, PBF, sterilization, qualification and validation.