Introduction

In discussions within ISO/REMCO and with its stakeholders, both reference material producers (RMPs) and reference material users (laboratories in universities and research institutes; regulators and control agencies; industrial laboratories; proficiency testing providers; metrology, standardization and accreditation bodies) complain about problems with the free circulation of reference materials (RMs). Their worldwide availability is hindered as a consequence of obstacles related to their transport, export and/or import in certain countries. This concerns certified reference materials (CRMs), which are qualified and accompanied by special certificates stating information on certified characteristics of the material,^[¹^][²^] and non-certified RMs used for proficiency testing or other interlaboratory comparisons and collaborative studies, respectively. The underlying reason for this is that RMs are mostly treated and legislated by authorities as bulk amounts of their matrix substance (human, animal or plant material, chemical substance, explosive, drug, etc.) and not as a (sometimes legally) mandatory tool needed to perform correct measurements, which are frequently the basis for regulatory or other society-relevant decisions. Thereby, it is often ignored that

— the content of potentially toxic material present in the RM is often insignificantly low1,
— the volume of RMs containing flammable and/or toxic solvents is generally small, mostly less than 30 ml2,
— RMs of biological origin (plant, animal, human) are neither entering the food chain, nor are they used in clinical treatments,
— RMs are exclusively used for measurement or testing purposes, and therefore the issue that they may contain pathogens or not is of limited concern when appropriate laboratory precautions are obeyed3.

Moreover, inconsistencies in legal restrictions may make the use of certain extremely important CRMs very difficult or even impossible. For instance, some important ATCC (American Type Culture Collection) CRMs for mammalian cell lines are regulated by the “Convention of International Trade in Endangered Species of Wild Fauna and Flora” (CITES), despite the fact they are cultivated by means of cell culture media and therefore play no role at all in the protection of animals.

PD ISO/TR 11773:2013

Global distribution of reference materials

Current

Published:

28 Feb 2013