Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1).
This Eropean Standar was approved by CEN on 27 July 2015 and includes Amendment 2 approved by CEN on 9 April 2019.
Significant technical changes since the last edition:
- The scope was expanded for the following fields of application within the medical area;
- “Obligatory test conditions” were replaced by “minimum test conditions” that have to be performed to pass the test.;
- An additional modified method is described to test ready-to-use products in a higher concentration than 80%;
- For the hygienic handrub and handwash method a test for virucidal activity against enveloped viruses with vaccinia virus was added;
- Relationship between EN 14476:2013+A2:2019 and the MDD was added;
- For the surface disinfection a test for virucidal activity against enveloped viruses with vaccinia virus was added and a test for limited spectrum virucidal activity was adenovirus and murine norovirus was added;
- The limited spectrum virucidal activity will cover norovirus, rotavirus and adenovirus;
- For dirty conditions the resuspension shall be done in PBS and not in water;
- Addition of large-volume-platting method;
According to the CEN-CENELC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standards: Austria, Belgum, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Also, all of them need to apply this change in in their accreditation scope ISO/IEC 17025 in order to cover needs of their clients.
From SHAPYPRO help to implementation method with our proficiency testing programs.
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