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BS EN ISO 7439:2011

$142.49

Copper-bearing contraceptive intrauterine devices. Requirements and tests

Published By Publication Date Number of Pages
BSI 2011 24
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PDF Catalog

PDF Pages PDF Title
11 Scope
Normative references
Terms and definitions
12 Intended performance
General
Clinical performance
Design attributes
General
Shape
13 Dimensions
IUD
Copper components
Thread
Insertion instrument
Tensile force
Stability
Shelf-life stability
In situ stability
14 Visco-elastic property
In situ detection
Materials
Design evaluation
General
Determination of dimensions
Determination of tensile force
Principle
Apparatus
15 Procedure
Test report
Test of visco-elastic property (memory test)
Principle
Procedure
16 Test report
Determination of barium sulphate content and identification
Ash content test
Identity test
Pre-clinical evaluation
Clinical evaluation
18 Manufacturing and inspection
Sterilization
Packaging
Information to be supplied by the manufacturer
General
Labelling of the primary container
19 Labelling of the secondary container
Instructions for use
20 Information intended for the woman
BS EN ISO 7439:2011
$142.49