Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 91

personal research develops entries for the PDS that would not otherwise exist. You should
produce a brief investigation report similar to that of the focus group.
5.4.4 Libraries
None of us are too far away from a library. In the modern Internet age libraries are available
online. All colleges and universities have well-stocked libraries and excellent access to
journals and standards. Most will be more than willing to help and it does not hurt to ask.
Equally, county, state, and national libraries are generally free and the staff is generally
helpful. You should also try to develop your own library by collecting and collating standards,
papers, and textbooks to which you refer on a regular basis. Let us examine the sort of items
you should refer to.
5.4.4.1 Standards
In general you should refer to ISO (International Standards Organization) documents as your
first point of call. National bodies such as ASTM in the USA and BSI in the UK both have
their own standards and online search engines that enable you to identify relevant standards
from keyword searches. There is little doubt that you will have to purchase a copy of the
main standards (e.g., ISO 13485) and those you refer to on a regular basis. However they are
expensive and to purchase them on a whim is not viable, hence the use of libraries to review
up-to-date copies is advisable.
The format of a standard is not unique but there are certain things you should know to enable
you to make full use of them. Normally the title of a standard is very explicit and makes
complete sense - however the title does not cover everything. Many standards are multi-
numbered (especially ISO); their numbers refer to the standard they equate to in a given state.
Don't forget to use the FDA equivalence database to check.
Quite often a standard is split into “parts” to make it more legible. The parts may not
all be of the same year of publication, which can be confusing. Here the scope becomes
important; the scope states what the standard actually covers. Associated with the scope is
a list of referenced/associated standards - these help your research to expand organically.
It is important to know that standards are still current; they are superseded and withdrawn
on a regular basis so always check before use. All of this before we have even read the
standard itself! When citing a standard in your PDS give a full reference: title, standard
number, section, and page number. All this helps the people who follow to find the relevant
document quickly. As with previous sources, produce a brief report to help with the
compilation of the PDS.
5.4.4.2 Journals and Learned Publications
There is little doubt that your design will be influenced by the current state-of-the-art.
Learned publications are one of the sources of this information. These are scientific journal