CEN/TC 216: its role in producing current and future European disinfectant testing standards

Abstract

CEN, the European Committee for Standardization, is a legal association comprising of National Standards Bodies (e.g. AFNOR, BSI, DIN) responsible for the production of European Standards (ENs) which are designed to facilitate the exchange of goods and services through the elimination of technical barriers to trade. CEN/TC 216 was conceived in the late 1980s with the scope Standardization of the terminology , requirements , test methods including potential efficacy under in-use conditions , recommendations for use and labelling in the whole field of chemical disinfection and antiseptics. Areas of activity include agriculture ( but not crop protection chemicals ), domestic service , food hygiene and other industrial fields , institutional , medical and veterinary applications . Following a meeting in 1990, the Technical Committee (TC) delegated its work to four Working Groups (WG); a Horizontal Working Group (HWG) and three Working Groups responsible for the Medical (WG1), Veterinary (WG2) and Food Hygiene, Domestic and Institutional (WG3) market sectors. Whilst the three WGs could develop test methods to assess bactericidal and fungicidal product activity, specialist Task Groups of the HWG have been established to provide specific guidance on viruses, spores, surface tests, ring trials and to harmonize methodology. The main objective of TC/216 is to produce test methods in a sequential, three phase mode. In Phase 1, the ability of a product to demonstrate bactericidal, fungicidal or sporicidal activity is tested. Phase 2 tests are divided into two steps. Step 1 tests are suspension tests to determine bactericidal, fungicidal, virucidal or sporicidal activity under laboratory conditions that simulate practical conditions. Step 2 tests are other laboratory tests e.g. handwash, handrub or surface tests that are more representative of in-use conditions. Phase 3 tests hope to give guidance to product users as to how to undertake suitable field trials. To date, eight standards have been produced and another 18 are in the final stages of development. WG1 has been the most prolific with 18 test methods under development whilst WG2 and 3 have six and three tests, respectively. Following production of standard test methodologies, the major issues for CEN/TC 216 are concerned with assessing the performance of the tests in practice, especially their statistical reliability. In addition, standards are being further harmonized and guidelines being developed to help product manufacturers and users select the appropriate tests for appropriate fields of use.