Quality Assurance
CarieScan Ltd is committed to ensuring that all products and services meet strict quality standards and local regulatory requirements.
We design, develop and manufacture all products in compliance with Council Directive 93/42/EEC and BS EN ISO 13485:2003.
Clinical Trials were conducted in accordance with BS EN ISO 14155: 2003 and ICH GCP.
Our Notified Body is SGS UK Ltd.
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CarieScan PRO has been tested to and met the following standards: |
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Standard |
Definition |
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BS EN ISO 13485:2003 |
Medical Devices – Quality Management Systems, EU & Canada. |
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BS EN ISO 9001:2000 |
Quality Management System – Requirements. |
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IEC/UL 60601-1 |
Medical Electrical Equipment, incl national variations for EU & US. |
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CSA-C22.2 No601.1-M90 Part 1 |
Medical Electrical Equipment, incl national variations for Canada. |
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EN 60601-1-2:2001 |
EMC: unintentional transmitters. |
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FCC 47CFR Part 15 |
Radio Frequency Devices. |
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EN 980:2003 |
Medical Device Symbols for Labelling. |
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FDA 21 CFR 820.30 |
Design Control Guidance for Medical Device Manufacturers. |
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BS EN ISO 14971:2000 |
Risk Management for Medical Devices. |
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ISO 11137:1994 |
Sterilisation of healthcare products. |
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IEC 62304: 2006 |
Life Cycle Processes. |
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ISO 10993-1:2003 |
Biological Examination of Medical Devices. |
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EN 1041:1998 |
Information Supplied by the Manufacturer. |
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ISTA 1a |
Transit Test. |
CarieScan PRO Sensors have been tested to and met the following standards: |
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|
Standard |
Definition |
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BS EN ISO 13485:2003 |
Medical Devices – Quality Management Systems, EU & Canada. |
|
BS EN ISO 9001:2000 |
Quality Management System – Requirements. |
|
EN 980:2003 |
Graphical symbols for use in the labelling of medical devices. |
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FDA 21 CFR 820.30 |
Design Control Guidance for Medical Device Manufacturers. |
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ASTM F1980 |
Accelerated Aging of Sterile Medical Device Packages. |
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ASTM F1929-98 |
Pack Seal Integrity. |
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EN 868-1:1997 |
Packaging materials and systems for medical devices which are to be sterilized. |
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ISO 2859-4:2002 |
Sampling procedures for inspection by attributes. |
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ISO 14644-1 Part 1 |
Cleanrooms and associated controlled environments. |
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BS 5295:1989 |
Specification for monitoring cleanrooms and clean air devices. |
