LH PERACETIC II

Water-soluble powder for the preparation of decontaminating/disinfecting/sterilizing solutions for invasive and non-invasive medical devices

CLASS IIB MEDICAL DEVICE

1. Composition:
100 g of powder contain: 35 g sodium percarbonate; Tetraacetylethylenediamine g 23; Enzymes, anionic surfactants, sequestrants, stabilisers, alkalizers and anticorrosives as required at 100 g.

2. Features:
powder suitable for the preparation of solutions which, depending on the concentration and contact time, are sterilizing, high-level disinfectants or decontaminants for the treatment of medical devices in hospitals and surgeries (doctors, dentists, etc.) The powder dispersed in warm water generates a chemical-physical balance which leads to the formation of peracetic acid and hydrogen peroxide resulting in high bactericidal activity and a broad spectrum of action. Summary of the chemical-physical and specific characteristics of the powder.

Summary of the chemical-physical and specific characteristics of the powder
solid, fine powder

physical state
odor	characteristic organic odor
color	whitish
relative density d 20/4	550 -650 kg/mc
pH (2% w/w)	8.5 +/- 1.5
decomposition temperature	64°c
flash point	na
boiling point	na
solubility in water	<= 30 g/litre at 30°c
solubility in other solvents	soluble in glycerin
Flash point	not inflammable
upper/lower limits of flammability in air (% vol)	na

3. Mechanism of action
The mechanism of action of LH PERACETIC II solutions is similar to that of peroxides in general and manifests itself on membrane proteins, and in particular on sulfhydryl groups, and on sulfur bonds in general, unbalancing the chemiosmotic function of membrane lipoproteins with rupture of the wall cellular and consequent permeation within the cell of elements capable of interrupting protoplasmic functions.

4. Microbicide characteristics - Spectrum of action
To document and confirm the characteristics of LH PERACETIC II, the following tests were performed:

Bactericidal activity
Applied method: EN 14561: Quantitative carrier test for the evaluation of the bactericidal activity for instruments used in the medical area.

Fungicidal activity:
Applied method: EN 14562: Quantitative carrier test for the evaluation of fungicidal activity for instruments used in the medical area.

Mycobactericidal activity
Applied method: EN 14348: quantitative test in suspension to evaluate mycobactericidal activity on instruments used in the medical area, in the presence of interfering substances.

Sporicidal and sterilizing sporicidal activity
Applied method: EN 13704: quantitative test in suspension for the determination of the sporicidal activity of chemical disinfectants, in the presence of interfering substances.

Virucidal activity:
Applied method: UNI EN 14476: Test for the quantitative determination of the virucidal activity of chemical disinfectants used in the medical area.

5. Indications - Fields of use
Water soluble powder indicated for deco