BS EN ISO 13504:2012
$142.49
Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
| Published By | Publication Date | Number of Pages |
| BSI | 2012 | 26 |
This International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.
It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.
With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions 3.2 Instruments 3.3 Stainless steel |
| 11 | 4 Classification 4.1 Intended usage (application) 4.2 Tissue contact 4.3 Reprocessing 5 Intended performance 6 Performance attributes |
| 12 | 7 Material selection 8 Performance evaluation 8.1 General 8.2 Pre-clinical evaluation 8.3 Clinical evaluation |
| 13 | 9 Manufacturing 9.1 General 9.2 Technical documentation 10 Reprocessing 10.1 Products supplied sterile 10.2 Products provided non-sterile 10.3 Reprocessing information 11 Information to be supplied by the manufacturer 11.1 General 11.2 Marking on instruments |
| 14 | 11.3 Labelling on the package 11.4 Instructions for use |
| 15 | Annex A (normative) Materials found acceptable for instrument manufacture |
| 21 | Annex B (informative) Cross-referencing of steel grades specified in international, regional |
| 23 | Bibliography |
