Case Study in Test Method Validation - ASTM …

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1March 3-5, Study in Test Method Validation - ASTM F1886 (2004), Visual ExaminationTodd Dehmer CPPSenior Packaging EngineerSt. Jude Medical, AFD Division2Presentation Overview Visual Inspection Usage ASTM F1886 Overview Reason for Validation Process for Validation On-going Validation3Visual Inspection Usage Many Medical Device Manufactures are referencing ASTM F1886 as the visual inspection Method they use to verify the sterile barrier integrity of their packaging. Are the MDM s referencing this Standard accurately? As specified per ASTM F1886: Should be validated to meet the precision and bias of ASTM F1886. Should be validated in accordance with AAMI/ANSI/ISO 11607-1:2006 and -2:2006? Work within your own quality department to determine Per ISO 11607 Part 1: Test methods test methods used to show compliance with this part of ISO 11607 shall be validated and Annex B contains a list of suitable test methods (such as ASTM F1886).

1. March 3-5, 2009. www.healthpack.net. Case Study in Test Method Validation - ASTM F1886 (2004), Visual Examination Todd Dehmer CPP. Senior Packaging Engineer

  Tests, Methods, Test methods