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  • 曼戈斐植入醫(yī)療器械檢測
貨物所在地:
江蘇蘇州市
更新時(shí)間:
2023-08-01 21:00:08
有效期:
2023年8月1日 -- 2024年2月1日
已獲點(diǎn)擊:
205
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產(chǎn)品簡介

植入醫(yī)療器械檢測系統(tǒng)給牙齒植入、導(dǎo)管血管、生物芯片和關(guān)節(jié)植入提供納米級(jí)的測量數(shù)據(jù)。?surf custom系統(tǒng)提供3D表面關(guān)鍵數(shù)據(jù)高解析力和高重復(fù)性精度。該非破壞性測量技術(shù)能夠?qū)ν该骰蚋叻垂獗砻孢M(jìn)行精密測量。所有數(shù)據(jù)都符合ISO25178標(biāo)準(zhǔn)。

詳細(xì)介紹

曼戈斐植入醫(yī)療器械檢測  的詳細(xì)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.

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