Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 166

port of call (as your PDS should have alluded to). Take care because standards in the EU are
different to those in the USA and you may need to check compatibility. The FDA website
has a consensus database you can search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfStandards/search.cfm .
All standards bodies have a web presence that is open to all. You are free to search at will.
For example, Figure 8.6 is a screenshot from the British Standards Institute of the results of a
standards search related to materials for suture wires.
The search has yielded ISO 10334, an international standard that must therefore have an
ASTM equivalent. This standard will probably list those materials you can choose from, and
those alone.
If there is a standard like this then your life becomes easy! There are a number of standard
standards. One of them is ISO 7153-1:2011 which is the standard for “ Surgical Instruments.
Metallic Materials. Stainless Steel ”: this is obviously a must for any surgical instrument
maker. Nearly every discipline has standards like this one, so find yours and get hold of it.
8.5.7 Materials Search Engines
There are two I would like to draw your attention to. The first is MatWeb
( http://www.matweb.com ) . This is an online materials search engine that is vast. It will not
be able to direct you to the exact material, but it will enable you to examine materials in fine
detail, obtain material properties, and pull down typical uses and suppliers. More importantly,
Figure 8.6
Illustration of a standards search for “material suture wires.”