Sterilisering och desinficering: allmänt

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products 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. The following areas are at least included:

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 ...);
— 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 ...);
— hotels;
— dwellings;
— clinically non-sensitive areas of hospitals;
— offices;
— etc.

c) other industrial areas:
— packaging material;
— biotechnology (yeast, proteins, enzymes, ...);
— pharmaceutical;
— cosmetics and toiletries;
— textiles;
— space industry, computer industry;
— etc.

EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2 This method corresponds to a phase 2 step 1 test.

1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

1.2 This document is not applicable to:

a) sterility testing for routine release of product that has been subjected to a sterilization process,

b) performing a test for sterility (see 3.12), and

NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.

c) culturing of biological indicators or inoculated products.

NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7[5].