TNI Logo The NELAC Institute

Standard Interpretation



SIR #: 97
Standard: 2003 NELAC
Section: Appendix D.3.8.b.2)iv)
Link to relevant standard

REQUEST:

What does "autoclave maintenance... shall include a pressure check" mean? Does that specifically mean that the pressure relief valve shall be checked and documented? If would be extremely helpful if these sections could be written more specifically.

TNI FINAL RESPONSE:

(Quality System Expert Committee/NELAP Accreditation Council, 1-x-11)

This suggestion is posted on the interpretations page of TNI: Autoclave Performance - With regard to the pressure check: since PV=nRT, checking the temperature and assuring no leaks (so that V is constant) is sufficient to meet the requirements of the standard.

Another suggestion: A note could be made in a log book indicating that seals were checked and no cracks were found.