SIST EN ISO 22794:2010 PDF

Overview

EN ISO 22794:2009 - Dentistry: Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected 2009‑01‑15) defines the required documentation and evaluation approach for implantable dental materials used to fill or augment bone in oral and maxillofacial surgery. The standard applies to both resorbable and non‑resorbable implantable materials, excluding products that are essentially pure (>90%) hydroxyapatite and certain other categories (autografts, allografts, membranes, or devices whose primary purpose is medicinal delivery). Evaluation covers physico‑chemical, mechanical, biological and clinical aspects.

Key topics and technical requirements

• Technical file contents - Minimum information to demonstrate safety and performance, including:
  • Chemical composition (complete composition, phases, elemental ratios, trace impurities; methods such as XRD/FTIR/DSC referenced)
  • Physical properties (form - granules, blocks, putty; dimensional data; porosity; particle size/shape; micrographs)
  • Intended use, precautions and instructions for use
  • Preclinical and clinical evaluation (biocompatibility and clinical performance evidence)
  • Manufacture (process controls, materials of animal origin where applicable)
  • Sterilization and packaging (validation and routine control of sterilization; packaging validation)
  • Additional information supplied by the manufacturer for safe use
• Evaluation scope - Physico‑chemical, mechanical, biological and clinical behaviour must be addressed as part of risk management.
• Referenced normative guidance - Cross‑references to standards used for biological evaluation, sterilization, packaging and clinical investigations (for example, ISO 10993 series, ISO 11135/11137/17665, ISO 11607, ISO 14155, ISO 14971).

Practical applications

• Preparing a technical file to support regulatory submissions and conformity assessment (e.g., CE marking) for dental bone grafts and augmentation materials.
• Guiding R&D and product characterization: selecting appropriate analytical and biological tests to document material safety and performance.
• Defining sterilization and packaging validation requirements tailored to implantable dental materials.
• Supporting clinical evaluation strategies and post‑market surveillance documentation.

Who should use this standard

• Dental biomaterial and medical device manufacturers
• Regulatory affairs and quality assurance teams preparing dossiers
• Notified bodies and regulatory reviewers assessing implantable dental devices
• R&D, testing laboratories, and clinical investigators involved in preclinical and clinical evaluation

Related standards

Relevant cross‑references include ISO 10993 (biocompatibility), ISO 14971 (risk management), ISO 11135/11137/17665 (sterilization), ISO 11607 (packaging), and ISO 14155 (clinical investigation).

Keywords: EN ISO 22794:2009, implantable materials, bone filling, augmentation, oral and maxillofacial surgery, technical file, dental biomaterials, sterilization, biocompatibility, regulatory compliance.