ISO 22794:2007 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 clinical 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.

ISO 22794:2007 Referenced Document

EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11134 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
ISO 14155:1996 Clinical investigation of medical devices
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*， 2009-10-01 Update
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 1942 Dentistry — Vocabulary — Amendment 1

2007 ISO 22794:2007 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file