Standards

  • There are a wide range of regulations, guidelines, standards and other baselines that are used in a multitude of application areas. Baselines are a set of requirements that serve as reference or as guidelines in a particular area. Quality baselines are tools at the service of quality improvement initiatives: they form a framework that determines what requirements and targets must be met.

    These baselines are used in assessment activities and make it possible to situate yourself with respect to the requirements and the goals that have been set. A so-called “voluntary” standard (non-regulatory, any organisation can choose to refer to it or not) is a professional reference framework that aims to provide guidelines, technical or quality prescriptions for products, and services or practices at the service of the general interest. It is usually the fruit of consensual collaboration between professionals and is upgradeable. Indeed, each standard is examined periodically and revised with the permanent aim of improvement and taking the realities in the field into account. The best-known organisation is no doubt ISO or the “International Organisation for Standardisation“, a non-governmental organisation representing a network of national institutes from a very large number of countries that produces international standards aiming to serve the interests of consumers and users.

    Here are some examples of baselines in the area of research animal houses:

    • General biological risk and confinement management guidelines:
    • In the same area, that of biological risks, there are standards relative to Biological Safety Cabinets (BSC):
    • The ISO 17665-1:2006 standard specifies the requirements relative to the development, validation and routine verification of the sterilisation process for medical instruments with humid heat (autoclaves)
    • The ISO 15883-1:2006 standard defines the general performance requirements for washer-disinfectors designed for cleaning and disinfecting reusable medical instruments
    • The ISO 14644-1:2015 standard applies to the classification of air quality according to the concentration of airborne particles in clean rooms
    • The ISO 16890-1:2016 standard defines a classification of air filters, based on the number of particles (“particulate matter” or PM), a review of the test procedures and the requirements in the area of filter assessment.
    • The NF T 72-281 standard (French standard) makes it possible to determine the bactericidal, fungicidal, yeasticidal and sporicidal activity for disinfecting surfaces by airborne application.
    • Regarding the safety of disinfectant products, it is not a question of applying a standard but, rather, the European Regulation No 528/2012 for placing biocidal products on the market and using them.