植入醫療器械檢測  的詳細介紹

Articulation surfaces of tibia and femur parts can be measured.

?The repeat accuracy of roughness measurements is < 0,2 nm (standard deviation 25 measurements).

?Measurements are areal. At highest resolution (100x) the size of a single measuring field is 160 μm x 160 μm.

?Roughness is determined according to ISO 25178 (S-parameters).

?Comparative analysis with ISO 4287 tactile roughness values is feasible (R-parameters).

?3D representation allows defect analysis and visual comparative tests (analogous to SEM).

Traceability of results and auditability

?Acceptance tests of every measurement system according to VDI/VDE guideline 2655.

?Measurement accuracy is determined and calibrated according to international standards and PTB-certified measurement standards:

?Depth standard Type A2 (ISO 5436-1, 57044 PTB 12)

?Lateral standard Type C3 (ISO 5436-1, 4097 PTB 01)

?Roughness standard Type D1 (ISO 5436-1, 57209 PTB 11)

?Users can calibrate the system independently or they can commission calibration.

?Auditability is guaranteed within FDA Regulation 21 Part 820.

Fast measurements and easy operation:

?Non-contact 3D measurements – fast and non-destructive: The confocal technology of our systems with a Multi-Pinhole-Disc allows the fast and non-contact acquisition of 3D data of the entire inspection area of the microscope. With more than 50 million measurement points generated per second 3D topographies or layer thickness information is available in incomparably short time .

?Easiest operation in this class: Thanks to a simplified user interface of the software, measurements and images are available with just a few clicks. The systems controls the settings of all parameters:

?Automatic setting of measurement area

?Automatic setting of optimal light intensity

Profile accuracy The reproduction of finest roughness structures with profile accuracy is a central quality criterion of the confocal metrology developed by NanoFocus. In industrial use, the comparability with tactile measurements conforming to standards is of highest importance.

Reproducible and robust A high reproducibility of the measurement results is an important pre-condition in quality-critical production control. Upon customer′s request, we prove conformity by means of standardized system capability analysis.

Additional rotary axis and mount for knee implants.

Automated measurement and analysis

For the automated measurement and analysis of specimen up to a programmed serial inspection of thousands of single measurements, NanoFocus offers a highly productive data bank based software. In addition to the industry-specific rights management, such as demanded by FDA Regulation 21 CFR Part 11, it allows a flexible programming of individual measurement and analysis strategies.

Customizations The measurement systems of the custom product group are set up by NanoFocus according to customer-specific requirements. Hardware and software can be retrofitted with numerous optional features. For the measurement of joint implants, customer-specific specimen mounts can be offered.