MEIKO® ACTIVE SPOROSAN® 8100 A+B

MEIKO^® ACTIVE SPOROSAN^® 8100 A+B*

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 A+B 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 A+B
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:	15 seconds (phase 2/1) 120 seconds (phase 3 in the bedpan washer; process-related exposure time)

Efficacy Range

MEIKO^® ACTIVE SPOROSAN^® 8100 A+B 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 and phase 3 in accredited laboratories prove the extraordinary efficacy and reliability of MEIKO^® ACTIVE SPOROSAN^® 8100 A+B.

Below you will find a detailed overview of the studies carried out with MEIKO^® ACTIVE SPOROSAN^® 8100 A+B 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 (2012+A2:2015), VAH (2015/2025)	2/1	Hygiene Nord GmbH	S. aureus	80% / 15 s
			E. hirae	97%/ 15 s
			P. aeruginosa	80%/ 15 s
			E. coli	80%/ 15 s
			P. mirabilis	80%/ 15 s
EN 17387 (2021)	3	Hygiene Nord GmbH	S. aureus	100%/ 120 s
			E. hirae	100%/ 120 s
			P. aeruginosa	100%/ 120 s
			E. coli	100%/ 120 s

Fungicidal and levurocidal
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 13624 (2021), VAH (2015/2025)	2/1	Hygiene Nord GmbH	C. albicans	80%/ 15 s
			A. brasiliensis	80%/ 15 s
EN 17387 (2021)	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 (2025)	2/1	HygCen GmbH	Adenovirus	80% / 15 s
			Murines Norovirus (MNV)	80% / 15 s
			Poliovirus	80% / 15 s
			Polyomavirus SV 40	80% / 15 s
EN 16777 EN 16615	3	Labor Enders	Murines Parvovirus (MPV)	100% / 30 s

Sporicidal
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 17126 (2019), VAH (2015/2025)	2/1	Hygiene Nord GmbH	B. subtilis	80% / 15 s
			B. cereus	80% / 15 s
			C. difficile	80% / 15 s
EN 17387 (2021)	3	Hygiene Nord GmbH	B. subtilis	100% / 120 s
			C. difficile	100% / 120 s
			B. cereus	100% / 120 s

Mycobactericial
standard	phase	laboratory	test germ	claimed concentration/ exposure time
EN 14348 (2005), VAH (2015/2025)	2/1	Hygiene Nord GmbH	M. terrae	80% / 15 s
			M. avium	80% / 15 s
EN 17387 (2021), EN 14348 (2005)	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 A+B.

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 A+B.

Language	MEIKO^®ACTIVE SPOROSAN^®8100 A+B (Part A)			MEIKO^®ACTIVE SPOROSAN^®8100 A+B (Part B)
German	Germany	Belgium	Switzerland	Germany	Belgium	Switzerland
English
French	France	Belgium	Switzerland	France	Belgium	Switzerland
Italian
Dutch	Netherlands	Belgium		Netherlands	Belgium