From: Norman Buck [Norman@CoyoteTech.com]
Sent: Thursday, April 03, 2003 3:58 PM
To: fdadockets@oc.fda.gov
Subject: Sec. 345.100 Male Condom Defects (CPG 7124.21)


Comments on your draft on
http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg345-100_draft.html

The draft references ISO 2859 Part 1 standard (as a replacement to
MIL-STD-105E).  But the multiple samples tables in this draft are from the
ANSI/ASQC Z1.4-1993 standard.  The current ISO 2859-1 standard multiple
sampling table have 5 samples (vs. 7 listed in the draft).

The ANSI/ASQC Z1.4-1993 standard is the commercial equivalent listed in the
official cancellation notice for the MIL-STD-105E.


Norman Buck
Senior Howling Wizard
Coyote Technologies Inc
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