The Routine Testing Agreement (RPTA or PTA) aims to facilitate routine testing agreements by providing a pre-approved set of testing conditions. Cornell`s Routine Product Testing Agreement (RPTA) is a mechanism by which an examiner can enter into a contract with a customer to test a product or adequacy device as part of a test protocol developed by the customer. The RPTA has been approved by the Colleges of Agricultural and Life Sciences, Human Ecology and Veterinary Medicine. Other institutions wishing to benefit from the agreement should contact the Office of Sponsored Programs. 1. Preface 2. The subject of Agreement 2.1. Definitions 2.2. Application field 2.3. Administrative information and responsibilities 3. General requirements 4.

Test 4.1. Test bases 4.2. Test location 4.3. Samples and samples 4.4. Responsibility for the drug during trials 4.5. Test 4.6. Test results 4.7. Test report 4.8. Selected samples 4.9. Validation of internal method 4.10.

Control instruments 5. Health and safety 5.1. Staff Qualification 5.2. Health, safety and environment 6. Publications and confidentiality 7. Subcontractors 8. Disclosure requirement 9. Right to exam 10. Stop exam 11. Cancellation of a test 12. Responsibility 1 3.

Payment obligations 14. Commitment mark 15. Appendix 1 – Responsible staff This 12-part contract model with an appendix contains agreements and controls necessary to avoid any misunderstanding that may lead to a test result or work of unsatisfactory quality. If you wish to outsource your medical device testing activities, you must ensure that the data and reports received are correct and that the legal requirements for medical devices for testing in 17025 and Good Laboratory Practice (BPL) and ISO 13485 are met. A test agreement is an important step to meet regulatory requirements and, secondly, to protect the interests of your business. The test laboratory has an integrated quality management system that meets international standards for quality management and quality systems for medical devices, including international vigilance and traceability requirements (EN ISO 13485 or equivalent). CONSIDERING, PixelPlus is a semiconductor construction company that deals with business design, marketing/sales of CMOS IMAGE SENSOR products, and Lana is a testing service for semiconductors; And in this context, preference is given to the use of accredited testing methods or trials, which are provided for by law. The review is conducted on the basis and implementation of U.S.

EU guidelines and guidelines, EN, ISO and CIS standards, legislation, national technical standards, safety techniques, health and environmental protection regulations, and/or internal testing programs and methods. Where there are legal requirements, they are mandatory. The RPTA must be used without modification. If the agreement is amended, it must be reviewed, approved and managed by the Office of Sponsored Programs. TESTS conducted under the RPTA must not include animals, human participants or controlled substances (recombinant DNA, transgenic plants, bio-hazardous substances, selected active substances). If protocols are required to carry out the work, the agreement must be verified, approved and managed by OSP. . Any notification to be taken is made in writing, by email or by fax.

H/W and Quantity: (Chip Probe/Final Testing with Test Program Development) All disputes between the parties concerning the validity, interpretation, implementation of this Agreement and this Agreement are governed by Korean laws and will be interpreted accordingly.