The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.<\/p>\n
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.<\/p>\n
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:<\/p>\n
vegetative bacteria,<\/p>\n<\/li>\n
mycobacteria,<\/p>\n<\/li>\n
bacterial spores,<\/p>\n<\/li>\n
yeasts,<\/p>\n<\/li>\n
fungal spores,<\/p>\n<\/li>\n
viruses,<\/p>\n<\/li>\n
bacteriophages.<\/p>\n<\/li>\n<\/ul>\n
This document does not cover processes for which the mode of action is based on immersing and\/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 4 Requirements 4.1 Efficacy tests <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 4.2 Distribution tests 5 Test method 5.1 Principle 5.1.1 Preliminary test to validate absence of residual effect 5.1.2 Efficacy test <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 5.1.3 Distribution test 5.2 Materials and reagents 5.2.1 Test organisms <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 5.2.2 Culture media and reagents 5.2.2.1 General 5.2.2.2 Culture media for bacteria, mycobacteria, spores, fungal spores and yeasts <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.2.2.3 Culture media and reagents for preparation of virus (test organisms 5.2.1.10 to 5.2.1.12.) 5.2.2.4 Culture media and reagents for preparation of bacteriophages (test organisms 5.2.1.13 to 5.2.1.14.) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.2.2.5 Interfering substance (See Annex C) <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.2.3 Carriers 5.2.3.1 General 5.2.3.2 Obligatory carriers 5.2.3.3 Additional carriers 5.3 Apparatus and glassware 5.3.1 General 5.3.2 Usual microbiological laboratory equipment, and in particular, the following: <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.4 Preparation and counting of test suspensions 5.4.1 Preparation of test suspensions (bacteria, mycobacteria, spores, fungal spores, yeasts) 5.4.1.1 Preservation of test organisms and stock cultures 5.4.1.2 Working culture of test organisms <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.4.2 Preparation of suspensions in interfering substance 5.4.2.1 Bacteria (see 5.2.1.1 to 5.2.1.6) <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.4.2.2 Bacterial spores (refer to 5.2.1.7) 5.4.2.3 Candida albicans (refer to 5.2.1.8) <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.4.2.4 Aspergillus brasiliensis (refer to 5.2.1.9) <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.4.2.5 Mycobacterium avium and Mycobacterium terrae (refer to 5.2.1.15 and 5.2.1.16) <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.4.3 Counting of suspensions prepared in interfering substance 5.4.3.1 Bacteria 5.4.3.2 Mycobacteria <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.4.3.3 Bacterial spores 5.4.3.4 Fungal spores and yeasts <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.4.4 Preparation and counting of viral suspensions 5.4.4.1 Viral stock suspension 5.4.4.2 Viral test suspension <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.4.4.3 Infectivity test 5.4.5 Preparation and counting of bacteriophage test suspensions 5.4.5.1 Host bacteria stock culture <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.4.5.2 Host bacteria working culture 5.4.5.3 Bacteriophage stock suspension 5.4.5.4 High-titre bacteriophage suspension <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 5.4.5.5 Preparation of bacteriophage suspension <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 5.4.5.6 Preparation of bacteriophages in interfering substance 5.5 Procedure for evaluating the automated airborne disinfection process activity 5.5.1 Procedure for evaluating the process activity according to conditions of use furnished by the manufacturer (bacteria, mycobacteria, spores, fungal spores, yeasts, viruses, bacteriophages) 5.5.1.1 Experimental conditions (obligatory, supplementary obligatory and additional) <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 5.5.1.2 Survival controls of test organisms on carriers (efficacy and distribution test) <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 5.5.1.3 Preliminary test to validate absence of residual effect (efficacy test and distribution test) <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 5.5.1.4 Efficacy and distribution test <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 5.5.2 Virucidal activity tests 5.5.2.1 General <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 5.5.2.2 Preliminary test to validate absence of residual effect (efficacy test and distribution test) <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 5.5.2.3 Efficacy test 5.5.2.4 Calculation and expression of results <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 5.5.3 Procedure for evaluating the mycobactericidal activity 5.5.3.1 General 5.5.3.2 Contamination of the carriers 5.5.3.3 Exposure of the test-carriers to the product under test 5.5.3.4 Counts on the carriers 5.6 Experimental data and calculations (bacteria, yeasts, fungal spores, bacterial spores, bacteriophages and mycobacteria) 5.6.1 General <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 5.6.2 Colony counting and limit thresholds 5.6.3 Determining number of test organisms N in bacterial, mycobacterial, bacterial spores, yeasts, fungal spores and bacteriophage suspensions (refer to 5.4) <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 5.6.4 Determining number of microorganisms T on control-carriers (refer to 5.5.1.2) 5.6.5 Determining values obtained in the preliminary test (refer to 5.5.1.3) 5.6.6 Determining the number of test organisms and plaques on test-carriers post- exposure and the reduction R (refer to 5.5.1.4.3) <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 5.7 Interpretation of results <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 5.8 Test report <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Annex A (normative)Summary of test requirements A.1 Efficacy tests <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | A.2 Distribution tests <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Annex B (normative) Distance between diffusion device and test-carriers <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | Annex C (normative) Interfering substance <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Annex D (normative) Preparation of spore stock suspensions of Bacillus subtilis D.1 Material and reagents D.1.1 Tryptone Glucose Broth (TGB): D.1.2 Yeast extract Agar (MYA): D.1.3 Centrifuge, capable of 10 000 gN acceleration D.2 Preparation of Bacillus spore stock suspensions <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | Annex E (normative)Graphical representation of the test procedure <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Chemical disinfectants and antiseptics. Methods of airborne room disinfection by automated process. Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities<\/b><\/p>\n |