What is ISO 23445 about?
ISO 23445 addresses dentistry that specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures, such as cutting holes or notches in and removing gingival tissue.
Measurement of dimensions as per ISO 8325:2004, 4.1 to 4.3, and 5.1, 5.2, 5.4, 5.5, and 5.6, as appropriate. The manufacturer shall validate that the accuracy of the measuring device is applicable. The accuracy of the measurement device shall be 1/10 of the required tolerance.
ISO 23445 also specifies the requirements for their marking and labelling for tissue punches that are about the recommended and the maximum speed, if not stated in instructions for use.
Who is ISO 23445 for?
ISO 23445 is useful for:
- Dentists
- Manufacturers of tissue punches
- Engineer and developer of tissue punches
- Manufacturer of medical devices
Why should you use ISO 23445?
Tissue punches are dental implant instruments used in conjunction with angled dental handpieces for surgical dental implant procedures such as cutting holes or notches in and removing gingival tissue.
By using ISO 23445 guidelines you will get basic requirements, dimensions, measurements, test methods, marking, labeling, and instructions for using tissue punches which will make them less traumatic to surrounding tissue and faster progress to the impression procedure which will ensure patients health and safety.
