Non-active surgical implants. Implants for osteosynthesis. Particular requirements

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

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What is ISO 14602 Requirements for non-active surgical implants for osteosynthesis about?

ISO 14602 is a European standard that specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants to manufacture efficient implants.

Who is ISO 14602 - Requirements for non-active surgical implants for osteosynthesis for?

ISO 14602 on  requirements for non-active surgical implants for osteosynthesis is useful for:

  • Manufacturers of implants for osteosynthesis
  • Test centres and medical laboratories
  • Regulatory authorities

Why should you use ISO 14602 -Requirements for non-active surgical implants for osteosynthesis?

Non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone healing or fusion and/or to provide support or correction.

ISO 14602 guides you regarding the intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer of non-active surgical implants to improve their efficiency and durability.

With obedience and compliance to ISO 14602, you can manufacture standardized non-active surgical implants to minimise hazards. In addition, ensure the health and safety of patients.