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BS EN 13704:2018

$167.15

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 2018 44
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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
2 undefined
8 1 Scope
9 2 Normative references
3 Terms and definitions
10 4 Requirements
5 Test method
5.1 Principle
11 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)
12 5.2.2.4 Neutralizer
5.2.2.5 Rinsing liquid (for membrane filtration)
5.2.2.6 Hard water for dilution of products
13 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
14 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
15 5.4.1.2 Spore test suspension
16 5.4.1.3 Counting of spore test suspension
5.4.1.4 Validation suspension (“Nv”, “Nv0”)
5.4.2 Product test solution
17 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
18 5.5.2.3 Membrane filtration method
19 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
20 5.6.1.2 Vc-values
5.6.2 Calculation
5.6.2.1 General
5.6.2.2 Determination of Vc-values
21 5.6.2.3 Calculation of N and N0
5.6.2.4 Calculation of Na
24 5.6.2.5 Calculation of Nv, Nv0
25 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
26 5.7.4 Expression of results
5.8 Conclusion
5.9 Test report
28 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
30 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
31 B.4.1.2 Validation
32 B.4.2 Membrane filtration method
B.4.2.1 General
B.4.2.2 Validation
34 B.5 Validation
35 Annex C (informative)Preparation of Clostridium sporogenes spore stock suspension
C.1 Culture media and reagents
36 C.2 Apparatus and glassware
C.3 Preparation of regenerated media and incubation conditions
C.4 Preparation of Clostridium spore stock suspension
38 Annex D (informative) Neutralizers and rinsing liquids
40 Annex E (informative) Example of a typical test report
42 Annex F (informative) Referenced strains in national collections
F.1 Bacillus subtilis
F.2 Bacillus cereus
F.3 Clostridium sporogenes
BS EN 13704:2018
$167.15