Follow Us:

I3CGLOBAL

Regulatory Consulting Services

Home TEST ITEM DATA SHEET (TIDS)

TEST ITEM DATA SHEET (TIDS)

1. IMPORTANT INFORMATION - Step 1 of 6
Provide specific information's requested below calculate sample size/Nos for biocompatibility testing. Remember to fill out a new form for each device you intend to test.

Please ensure that the dispatched TEST ITEM LABEL which requires minimum, the following details:

 

  1. Name of the product or Code No
  2. Batch or Lot number,
  3. Serial number (wherever applicable),
  4. Date of manufacture,
  5. Use before date,
  6. Storage conditions,
  7. Name and address of the manufacturer,
  8. Sterile state and the sterilization method.

 

Please note that the identity and characterization of the test item in terms of providing its batch/lot number, manufacturing and expiry dates, and making the test item available for testing by the test facility within its expiry date would be the responsibility of the sponsor. No analysis will be performed at our lab on expired item.  This is an essential requirement for compliance to the OECD GLP principles as per Section 6.1.1 of OECD GLP Doc. No. 1 (ENV/MC/CHEM(98)17).  If any the above information is not available, this will be clearly mentioned in the Study Director’s statement issued with the final report of the study.