33

Standards on Biomaterials
Maria Vittoria Primiceri and Sandro Paci

33.1. Introduction
The first norms appeared, somehow, to satisfy military demands. Round
about the year 1400 some built weapons (rifles and guns) while others made
bullets, so that there was much confusion between the diameter of the gun
and the ammunition.
Since then much has been done. Nowadays we are aware that
regulations must be harmonized in order to preserve man’s health and
safety. We hope that this will act as the small hole to demolish the huge dike
of indifference and human ignorance that has made us slaves of barons and
conventions imposed by private interest rather than by love for one’s
neighbor. The contents of this book should testify about the will to
communicate with and consider human beings as part of one race, clan, and
family.

33.1.1. The Need for Standards

Since the European Nations felt the need to form an economic union,
social and political problems were also considered almost automatically.
After the ratification of the Treaty of Rome in 1970, the European Com-
mittee realized that the legislative system being created from the experience
of the “First approach,” dated 1973 (Directive 73/23/CEE concerning low
tension), would be long and difficult. The task of the European legislator
was mainly hindered by the different interpretations of the Member States
on production and application.

Maria Vittoria Primiceri Notarbartolo & Gervasi SpA, Via Savoia, 82, 00198 Roma,
Italy. Sandro Paci ENEA, Via Anguillarese, 306, 00100 Roma, Italy.
Integrated Biomaterials Science, edited by R. Barbucci. Kluwer Academic/Plenum Publishers,
New York, 2002.

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986 Maria Vittoria Primiceri and Sandro Paci

Thus the European Committee decentralized the production phase to

the Member Countries charged with developing the most suitable technical
standards in order to develop the topics under discussion in connection with
directives concerning safeguarding human health as well as domestic ani-
mals. Each Member State became aware of the benefits brought about by
harmonizing technical standards in order to avoid complete industrial
chaos, and felt the need to create bodies that would control and promote
standards that were suitable for the European Community.
Actually these bodies already existed in Europe as well as in the rest
of the world; in fact the CEN (European Committee of Regulations) and
ISO (International Organisation for Standardisation) were born long before
the Community addressed the problem. They were getting organized in
order to operate extensively so that the partners in these organizations
would comprise for the CEN all the European standardization bodies, and
for the ISO the same ones outside of the U.S.A., Canada, Japan, and
elsewhere, except for Australia and New Zealand.

33.1.2. National, EN, and ISO Standards

One cannot speak of technical standards without giving background
information about the standardization bodies. They were mainly created to
standardize the mechanical needs of war requests, especially since the First
World War.
In Italy the standardization body is divided in two parts: the CEI
(Italian Electrotechnical Committee), which processes all requests in the
electromechanical field, and the UNI (National Body of Unification), which
processes all requests of the other industrial sectors.
The CEI was created in 1909 at the initiative of the General Council
of the Italian Electrotechnical and Electronics Association (AEI) and its
jurisdiction was recognized in 1967. Now, it forms part of the CENELEC
at a European level and of the IEC (International Electrotechnical Commis-
sion) at an international level. The CEI takes an interest in standards
pertaining to electrotechnical subjects, and in Italy its publications have
become technical standards for electric installations and their safety.
The UNI has more recent roots; it was founded in 1921 and its
jurisdiction was acknowledged in 1955. Besides being a standardization
body, the UNI has a social and economical role in promoting security,
quality of life, and environmental preservation through the regulation of
products, processes, and services.
Italian standards are marked via the promulgating body, UNI or CEI,
followed by a number that represents the list to which the standard belongs.
The CEI is a partner and member of the CENELEC organization which, in