MEIKO® ACTIVE SPOROSAN® 8100

MEIKO^® ACTIVE SPOROSAN^® 8100*

Highly effective two-component disinfectant concentrate for use in washer-disinfectors for the reprocessing of non-invasive medical devices.

Efficacy data | Product brochure | Safety data sheets | Vigilance

*Note! The conformity of MEIKO^® ACTIVE SPOROSAN^® 8100 with the Medical Device Regulation (MDR, EU 2017/745) has not yet been established.

Product Features

Note: Conformity with the Medical Device Regulation (MDR, EU 2017/745) is not yet available. The following product characteristics are aimed for as part of the conformity procedure.

Product name:	MEIKO^® ACTIVE SPOROSAN^® 8100
Product type:	2-component disinfectant concentrate
Medical device class:	IIA
Intended use:	Disinfection of non-invasive medical devices in washer- disinfectors
Active substance:	Peroxynitrous acid (ONOOH) generated from hydrogen peroxide and nitrite
Compatibility:	only to be used in approved washer-disinfectors
Container:	2 x 5 L
Shelf life:	24 months
Casual temperature:	0 to 25 °C
Spectrum of effects:	bactericidal, fungicidal, levurocidal, virucidal, sporicidal and mycobactericidal
Exposure time:	120 seconds (phase 3)

Efficacy Range

MEIKO^® ACTIVE SPOROSAN^® 8100 is a highly effective two-component disinfectant concentrate for use in washer-disinfectors for the reprocessing of non-invasive medical devices. A large number of efficacy studies in phase 2/1, phase 2/2 and phase 3 in accredited laboratories prove the extraordinary efficacy and reliability of MEIKO^® ACTIVE SPOROSAN^® 8100.

Below you will find a detailed overview of the studies carried out with MEIKO^® ACTIVE SPOROSAN^® 8100 in accredited laboratories.

Notes:

In previous studies, the product name Sporosan^® WD42 was used.
A concentration of 100 % corresponds to the diluted application concentration.
Phase 3 - Trials confirm the efficacy of Sporosan^® in the bedpan washer. This refers exclusively to the disinfection step, (excluding rinse cycles and the hot steam step).

Bactericidal:
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 13727+VAH (2015/2022)	2/1	Hygiene Nord GmbH	S. aureus	80% / 15 s
			E. hirae	50%/ 15 s
			P. aeruginosa	80%/ 15 s
			E. coli K12	50%/ 15 s
			P. mirabilis	50%/ 15 s
		Dr. Brill + Partner GmbH	S. aureus	50%/ 15 s
			E. hirae	50%/ 15 s
			P. aeruginosa	50%/ 15 s
			E. coli K12	50%/ 15 s
			P. mirabilis	50%/ 15 s
		HygCen GmbH	S. aureus	50%/ 15 s
			E. hirae	50%/ 15 s
			P. aeruginosa	10%/ 15 s
			E. coli K12	50%/ 15 s
			P. mirabilis	10%/ 15 s
EN 17387	2/2	Hygiene Nord GmbH	S. aureus	50%/ 60 s
			E. hirae	97%/ 60 s
			P. aeruginosa	97%/ 60 s
	3	Hygiene Nord GmbH	S. aureus	100%/ 120 s
			E. hirae	100%/ 120 s
			P. aeruginosa	100%/ 120 s
			E. coli K12	100%/ 120 s

Fungicidal and levurocidal:
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 13624+VAH (2015/2022)	2/1	Hygiene Nord GmbH	C. albicans	50%/ 15 s
			A. brasiliensis	80%/ 15 s
		Dr. Brill + Partner GmbH	C. albicans	50%/ 15 s
			A. brasiliensis	80%/ 15 s
		HygCen GmbH	C. albicans	50%/ 15 s
			A. brasiliensis	80%/ 30 s
EN 17387	2/2	Hygiene Nord GmbH	C. albicans	50%/ 60 s
			A. brasiliensis	50%/ 60 s
	3	Hygiene Nord GmbH	C. albicans	100%/ 120 s
			A. brasiliensis	100%/ 120 s

Virucidal:
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 14476 +VAH compatibility	2/1	Dr. Brill + Partner GmbH	Adenovirus	80% / 15 s
			Murine Norovirus (MNV)	80% / 15 s
			Poliovirus	97% / 15 s
			Polyomavirus SV 40	80% / 15 s
EN 16777	2/2	HygCen GmbH	Adenovirus	97%/ 60 s
			Murine Norovirus (MNV)	97%/ 60 s
			Parvovirus	97%/ 60 s
	3	Labor Enders	Parvovirus	100% / 120 s

Sporicidal:
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 17126 +VAH (2015/2022)	2/1	Hygiene Nord GmbH	B. subtilis	97% / 15 s
			B. cereus	80% / 15 s
			C. difficile	50% / 15 s
		HygCen GmbH	B. subtilis	97% / 15 s
			B. cereus	97% / 15 s
			C. difficile	80% / 15 s
EN 17387	2/2	Hygiene Nord GmbH	B. subtilis	97% / 60 s
			B. cereus	97% / 60 s
			C. difficile	97% / 60 s
EN 17387 & EN 17126	3	Hygiene Nord GmbH	B. subtilis	100% / 120 s
			B. cereus*	100% / 20 s & 100% / 120 s
			C. difficile	100% / 120 s

* Two time points were examined for this pathogen.

Mycobactericidal:
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 14348 + VAH (2015/2022)	2/1	Hygiene Nord GmbH	M. terrae	97% / 30 s
			M. avium	80% / 30 s
EN 17387	2/2	Hygiene Nord GmbH	M. terrae	50% / 60 s
			M. avium	50% / 60 s
	3	Hygiene Nord GmbH	M. terrae	100% / 120 s
			M. avium	100% / 120 s

Operating Manual

Here you will find the operating instructions for MEIKO^® ACTIVE SPOROSAN^® 8100.

Language	Document
German	not yet available
English	not yet available
French	not yet available

Safety Data Sheets

Here you can find the safety data sheets for MEIKO^® ACTIVE SPOROSAN^® 8100.

Language	MEIKO^® ACTIVE SPOROSAN^® 8100 (H)	MEIKO^® ACTIVE SPOROSAN^® 8100 (Part N)
German
English	not yet available	not yet available
French	not yet available	not yet available