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BS EN 13704:2018 – TC:2020 Edition

$217.84

Tracked Changes. Chemical disinfectants. Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas. Test method and requirements (phase 2, step 1)

Published By Publication Date Number of Pages
BSI 2020 96
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This document specifies a test method (phase 2/step 1) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. This European Standard applies at least to the following: a) processing, distribution and retailing of: 1) food of animal origin: – milk and milk products; – meat and meat products; – fish, seafood, and related products; – eggs and egg products; – animal feeds; – etc.; 2) food of vegetable origin: – beverages; – fruits, vegetables and derivatives (including sugar, distillery, etc.); – flour, milling and baking; – animal feeds; – etc.; b) institutional and domestic areas: – catering establishments; – public areas; – public transports; – schools; – nurseries; – shops; – sports rooms; – waste containers (bins, etc.); – hotels; – dwellings; – clinically non sensitive areas of hospitals; – offices; – etc.; c) other industrial areas: – packaging material; – biotechnology (yeast, proteins, enzymes, etc.); – pharmaceutical; – cosmetics and toiletries; – textiles; – space industry, computer industry; – etc. Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80 % or less. NOTE The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used.

PDF Catalog

PDF Pages PDF Title
54 undefined
60 1 Scope
61 2 Normative references
3 Terms and definitions
62 4 Requirements
5 Test method
5.1 Principle
63 5.2 Materials and reagents
5.2.1 Test organisms
5.2.2 Culture media and reagents
5.2.2.1 General
5.2.2.2 Water
5.2.2.3 Tryptone Soja Agar (TSA)
64 5.2.2.4 Neutralizer
5.2.2.5 Rinsing liquid (for membrane filtration)
5.2.2.6 Hard water for dilution of products
65 5.2.2.7 Interfering substance
5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment) and, in particular, the following
66 5.4 Preparation of spore test suspension and test solutions
5.4.1 Spore suspensions
5.4.1.1 Stock spore suspension of test organism
67 5.4.1.2 Spore test suspension
68 5.4.1.3 Counting of spore test suspension
5.4.1.4 Validation suspension (“Nv”, “Nv0”)
5.4.2 Product test solution
69 5.5 Procedure
5.5.1 Choice of experimental conditions
5.5.2 Test procedure for assessing the sporicidal effect of the product
5.5.2.1 General
5.5.2.2 Dilution-neutralization method
70 5.5.2.3 Membrane filtration method
71 5.5.3 Validation of dilution neutralization and membrane filtration method
5.6 Calculation and expression of results
5.6.1 Overview of the different suspensions and test mixtures
5.6.1.1 General
72 5.6.1.2 Vc-values
5.6.2 Calculation
5.6.2.1 General
5.6.2.2 Determination of Vc-values
73 5.6.2.3 Calculation of N and N0
5.6.2.4 Calculation of Na
76 5.6.2.5 Calculation of Nv, Nv0
77 5.6.2.6 Calculation of A, B and C
5.7 Verification of methodology
5.7.1 General
5.7.2 Control of weighted mean counts
5.7.3 Basic limits
78 5.7.4 Expression of results
5.8 Conclusion
5.9 Test report
80 Annex A (normative) Preparation of Bacillus subtilis and Bacillus cereus spore stock suspensions
A.1 Material and reagents
A.2 Preparation of Bacillus spore stock suspensions
82 Annex B (normative) Validation of dilution-neutralization and membrane filtration methods
B.1 Principle
B.2 Preparation of spore suspension
B.3 Preparation of product test solution
B.4 Test for validation
B.4.1 Dilution-neutralization method
B.4.1.1 General
83 B.4.1.2 Validation
84 B.4.2 Membrane filtration method
B.4.2.1 General
B.4.2.2 Validation
86 B.5 Validation
87 Annex C (informative)Preparation of Clostridium sporogenes spore stock suspension
C.1 Culture media and reagents
88 C.2 Apparatus and glassware
C.3 Preparation of regenerated media and incubation conditions
C.4 Preparation of Clostridium spore stock suspension
90 Annex D (informative) Neutralizers and rinsing liquids
92 Annex E (informative) Example of a typical test report
94 Annex F (informative) Referenced strains in national collections
F.1 Bacillus subtilis
F.2 Bacillus cereus
F.3 Clostridium sporogenes
BS EN 13704:2018 - TC
$217.84