From scientific standards to global standards

The standardization system referred to in this article is that of the standardization organizations officially recognized by the European Union and the European Free Trade Association (EFTA) for the development of voluntary standards at European level following the principles of the World Trade Organization (OMC) in the standardization field; and that participate in the of the Committee of Technical Barriers to Trade of the World Trade Organization at an international level and act as the communication point for all the national standardization bodies that subscribe that Code.

Standards are voluntary technical documents that set out requirements for a specific item, material, component, system or service, or describe in detail a particular method, procedure or best practice. Standards provide people and organizations with a basis for mutual understanding and are used as tools to facilitate communication, measurement, commerce and manufacturing. The initiative to develop a standard is taken by interested stakeholders who consider that a particular standard could address specific needs or provide solutions for repeated situations.

Standards are developed and defined through a process of sharing knowledge and building consensus among technical experts nominated by interested parties and other stakeholders including businesses, consumers or environmental groups, among others. These experts make their contributions into Technical Committees (TCs) included in the structure of the Standardization Organizations at national, European or international level. These organizations cooperate between themselves and coordinate their procedures and working criteria for the maximum benefit of the system. When Technical Committees have a too large field of activity, they are subdivided into Subcommittees and Working Groups that focus on more specific targets.

The playing field of standardization at European and international level of relevance for BioRoboost is formed by the European Committee for Standardization (CEN) and the International Standardization Organization (ISO) of which UNE is the Spanish member representing the Spanish interests and coordinating the Spanish participation. In CEN and ISO is where experts in synthetic biology can find standards or standards under development close to their own research fields such as ISO/TC 276 “Biotechnology” an active committee which scope is the standardization in the field of biotechnology processes that includes terms and definitions; biobanks and bioresources; analytical methods; bioprocessing; data processing including annotation, analysis, validation, comparability and integration; and metrology. But there are others working on biological and clinical evaluation of medical devices, clinical laboratory testing and in vitro diagnostic test systems, molecular biomarkers or tissue-engineered medical products, to give a few examples. BioRoboost maintains an open debate on the convenience and opportunity to develop standards on synthetic biology. The benefits that standards will bring seem to be well accepted and recognized, the debate falls on what would be the best platform, when and how. UNE is a partner of BioRoboost for the link with the formal or open standardization as some call the work done in CEN, ISO and their counterparts.

Text by: Elena Ordozgoiti de la Rica (UNE), March 2020

Leave a Comment