Overview
EN ISO 14602:2011 (identical to ISO 14602:2010) is a Level‑2 international standard that defines particular requirements for non‑active surgical implants for osteosynthesis. It complements the general requirements in ISO 14630 and provides detailed guidance on the design, materials, evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer for implants used to stabilize bone (osteosynthesis) in trauma or corrective surgery.
Key topics and technical requirements
This standard focuses on practical, safety‑related aspects of osteosynthesis implants, including:
- Intended performance and purpose
- Clear definition of functional characteristics and intended conditions of use for the implant.
- Design attributes
- Design considerations that affect mechanical performance, biocompatibility and implant retrieval or in‑situ use.
- Materials
- Selection of materials with proven clinical performance; Annex C lists ISO material standards considered acceptable through clinical use.
- Design evaluation
- Pre‑clinical and clinical evaluation requirements and ongoing post‑market surveillance to monitor long‑term performance.
- Manufacturing
- Process controls and traceability to ensure consistent product quality.
- Sterilization and packaging
- Requirements for validated sterilization methods and packaging that maintains sterile barrier integrity until use.
- Information and labelling
- Instructions for use, labelling, restrictions on combinations with other devices, and implant markings (including special purpose markings).
- Standards cross‑references
- Annexes B and D list Level‑3 and related ISO standards for specific implant types, testing and design evaluation.
Practical applications and who uses this standard
EN ISO 14602:2011 is used by:
- Medical device manufacturers designing, producing or marketing osteosynthesis implants (plates, screws, rods, pins).
- Regulatory and quality assurance teams preparing technical files, conformity assessments and demonstrating compliance with medical device directives/regulations.
- Clinical engineers and surgical instrument designers ensuring compatibility between implants and instrumentation.
- Testing laboratories conducting pre‑clinical mechanical, biocompatibility and sterilization validation tests.
- Notified bodies and regulators assessing conformity to Essential Requirements (see Annex ZA for relationship to EU Directive 93/42/EEC).
Related standards
- ISO 14630 (general requirements for non‑active surgical implants)
- ISO/TR 14283 (fundamental principles correspondence)
- Level‑3 ISO standards for specific implant types and test methods (refer to Annexes B–D of ISO 14602)
Keywords: EN ISO 14602:2011, ISO 14602:2010, osteosynthesis implants, non‑active surgical implants, medical device standards, sterilization, design evaluation, materials, post‑market surveillance.
