TABLE OF CONTENTS Standards are provided by non-governmental international organisations, (e.g., ISO), pharmaceutical compendiums, and private organisations, (e.g., Association for the Advancement of Medical Instrumentation (AAMI)), as well as individual regulatory bodies of governments (e.g., FDA, DHSS) [67].
These standards include sterilisation and validation.
In the following section, the harmonisation of standards for sterilisation will be discussed.
The principle standard setting organisations for sterilisation are:
American National Standards Institute (ANSI)
Association for the Advancement of Medical Instrumentation (AAMI)
European Community for Normalisation (CEN)
The International Standards Organisation (ISO)
ISO standards are generally recognised by the FDA, DHSS and the international community. AAMI standards have long been used as guidelines by the FDA, in their compliance efforts. The CEN standards are documents that have been prepared for the European Community (EC) harmonisation of 1992, in lieu of individual European country compendia and regulations.
In the past few years considerable effort has been exerted by AAMI, FDA, European and other international countries to determine international standards to obtain harmonisation with the CEN, and regulations of other individual countries.
This task has not been easy. Differences between individual countries and other sterilisation standard setting groups existed. Other standards setting organisations involved in sterilisation are ASTM, Parenteral Drug Association (PDA), Health Industry Manufacturing Association (HIMA), and other sterilisation guidance organisations.
The United States strategy was to set new sterilisation standards through ANSI/AAMI that influence the ISO standards to bring about harmonisation of requirements throughout the...
