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_____________________________________ _________________________________
(Name/Sign & Date) (Name/Sign & Date)
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SOI-083/F1 Rev.1 Malaysia
Ref No.:_________ Page ____of____
F88/F88M
NOTE:
1) Validation no: X-13-007
2) The product only consist one size CH 16.
This document contains proprietary information. It may not be reproduced without prior written approval.
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SOI-083/F1 Rev.1 Malaysia
Ref No.:_________ Page ____of____
C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
Visual Inspection Shall meet the
( Dimension requirement defined.
1
measurement OD & Minimum OL 360mm
OL) OD 5.3-0.33+0.33
When tested accordance
with the method given in
Security of Drainage
2 annex B, the drainage
funnel
funnel shall not part from
the test connector.
The minimum force at
break shall be given as in
Security of Table 2 EN 1618: 1997
3
Connector Specification Outer
Diameter (OD): OD >4mm
= 15N
4 Tensile Properties When tested per Annex B,
Force at break shall be
more than 20N or until
specified force is applied
This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
Ref No.:_________ Page ____of____
C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
for catheter outer diameter
more than 4mm.
Visual Inspection on Packaging seal shall not
5
packaging seal have any seal defect
Package shall not show
6 Bubble leak test
any sign of leak
Colored water leak Package shall not show
7
test any sign leak
Seal strength value
8 Seal strength test
2.54N
This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
Ref No.:_________ Page ____of____
C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
Disposition (Pass/Fail)
Recorded by (Sign/Date):
Verified by (Sign/Date):
(QA-Validation)
Verified by (Sign/Date):
(QA Director/Manager)
Verified by (Sign/Date):
(RA Manager)
Verified by (Sign/Date):
(R&D Manager)
Verified by (Sign/Date):
(VS Director/Manager)
Comments/Remarks:
This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
Ref No.:_________ Page ____of____
C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
NOTE:
1) Record result in quantity fail/quantity tested
This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia