Resumen:
The document specifies a test method (phase 2/step 2) and requirements for the minimum mycobactericidal or tuberculoidal activity of chemical disinfectants products that form a homogeneous, physically stable preparation in hard water and that ared for instrument disinfection in the medical area whether this instruments are defined as medical devices or not. This includes products used for the disinfection of surgical instruments, anaesthetic equipment, endoscopes etc. which are disinfected by immersion into the product.
Das Dokument legt Prüfverfahren und Anforderungen unter speziellen praxisnahen Bedingungen (Phase 2/ Stufe 2) für die mykobakterizide und/oder tuberkolozide Wirkung von chemischen Desinfektionsmitteln für Instrumente, die im humanmedizinischen Bereich verwendet werden, fest. Diese Norm wird unter einem Mandat zur EU-Richtlinie 93/42/EWG "Medizinprodukte" erarbeitet.
Keywords:
Antiseptics, Chemicals, Definitions, Determination, Disinfectant tests, Disinfectants, Disinfection, Effects, Efficiency, Efficiency testing, Evaluations, Fungicides, Human medicine, Hygiene, Medical instruments, Medical sciences, Mycobacteriaceae, Quantitative analysis, Specification (approval), Suspension tests, Suspensions (chemical), Testing