PCA accreditation

Ordering safety and essential performance tests

General information

The Laboratory provides all necessary forms in PDF format.
Required forms must be completed electronically or manually (white fields are filled by the Ordering Party, gray fields are filled by the Laboratory).
Forms should be stamped and signed (in the absence of a stamp you should submit a legible signature).
Forms should be sent by the post, delivered in person or sent with scans along with signatures via e-mail.

Basic safety and essential performance tests ordering

To make an order of basic safety and essential performance tests and you should:
  • determine the subject of the test and the standard by which the test should be performed. Mark in the Scope of tests Form (PL-4.7.1_5). For a single study, you can use the Scope of a Single Test Form (PL-4.7.1_10),
  • send an inquiry with completed forms PL-4.7.1_5_Eng or PL-4.7.1_10_Eng and the instruction manual and / or the technical description.
In case of acceptance of sent offer:
  • complete and sign the Arrangement Form (PL-4.4.1_1), received with the offer,
  • fill out the External Order Form (PL-4.7.1_3) to which the general terms and conditions for acceptance of the order are attached,
  • provide the test equipment in accordance with the specifications, including the operating instructions and / or the technical description together with the completed forms PL-4.4.1_1, PL-4.7.1_3,
  • in the case of full basic safety and essential performance tests in accordance with the general standard EN 60601-1 and / or specific standards, provide the following documents:
    • accompanying documentation containing operating instructions, technical description, complying with the requirements of EN 60601-1,
    • list of critical components (safety factors) of network and application part and others if applicable (section 4.8 of EN 60601-1), and technical documentation to verify their use in the device,
    • certificate of critical elements, confirming compliance of the performance with the requirements,
    • biocompatibility certificates for parts and accessories (if applicable),
    • electromagnetic Compatibility (EMC) test reports, if applicable,
    • test results for compliance with EN 60601-1-6 and EN 62366,
    • documentation of risk management of the examined object.
  • the Laboratory at the test stage will be able to require from the Ordering Site other necessary documents relating to the examined object to confirm compliance.

CalibrationSafety tests range