Overview
ISO 14602:2010 - Non‑active surgical implants - Implants for osteosynthesis - Particular requirements - is a Level‑2 ISO standard that supplements the general requirements of ISO 14630. It specifies particular requirements for non‑active surgical implants used in osteosynthesis (orthopaedic fixation), addressing intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and the information supplied by the manufacturer.
This standard helps manufacturers and regulators demonstrate conformity with fundamental safety and performance principles (including those in ISO/TR 14283) and can support compliance with medical device regulatory frameworks (for example, the essential requirements of European Council Directive 93/42/EEC as amended).
Key topics and requirements
- Intended performance: Define intended purpose (e.g., fracture treatment, spinal stabilization, arthrodesis, bone lengthening, tendon/ligament reconstruction) and typical anatomical sites.
- Functional characteristics: Describe fixation type, anchorage, component linkage, removability, and action on bone and adjacent tissues (stabilization, compression/distraction, alignment control).
- Design attributes: Requirements for interconnecting systems, dimensional tolerances, anatomical sizing, ergonomics and measures to reduce use error during implantation.
- Materials: Material selection consistent with ISO 14630 and Annex C (informative list of materials with proven clinical use).
- Design evaluation:
- Pre‑clinical: in‑vitro handling tests, cadaveric evaluation where required, static/dynamic mechanical testing, validated modelling and biomechanical simulations.
- Clinical evaluation and post‑market surveillance in line with ISO 14630.
- Annex D lists relevant testing and design‑evaluation standards.
- Manufacturing, sterilization and packaging: Specific controls to preserve device integrity and sterility through distribution.
- Information supplied: Labelling, instructions for use, restrictions on combinations and implant marking requirements.
Practical applications and users
ISO 14602 is directly applicable to:
- Medical device manufacturers designing and producing orthopaedic and spinal fixation implants.
- Design and R&D engineers specifying materials, tolerances and biomechanical testing.
- Quality assurance and regulatory teams preparing technical documentation and conformity evidence.
- Notified bodies and regulatory assessors reviewing device compliance and clinical evidence.
- Clinical researchers and hospitals evaluating implant performance and post‑market data.
Typical use cases include device development for fracture fixation plates, screws, rods, spinal constructs and other osteosynthesis systems, and preparing pre‑clinical test plans, clinical evaluations and labelling.
Related standards
- ISO 14630 - General requirements for non‑active surgical implants (to be applied together).
- ISO/TR 14283 - Fundamental principles correspondence.
- Annexes in ISO 14602 list level‑3 standards, material standards and testing standards helpful for specific implant types.
Keywords: ISO 14602, implants for osteosynthesis, non‑active surgical implants, orthopedic implants standard, design evaluation, implant materials, sterilization, medical device regulatory compliance.
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