DIN EN ISO 22794:2009 PDF

Scope: This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (> 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and ciinical aspects and behaviour of these implantable dental materials. Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard.

DIN EN ISO 22794:2009 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1*， 2009-12-01 Update
ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 1942 Dentistry — Vocabulary — Amendment 1

2009 DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15); German version EN ISO 22794:2009
2009 DIN 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 version 2009-01-15); English version of DIN EN ISO 22794:2009-11
2007 DIN EN ISO 22794:2007 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version EN ISO 22794:2007