Sterilisering och desinficering: allmänt

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.

This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see Note 1).

This document is not applicable to material of human origin.

This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2 and Note 3).

This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.

The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4).

This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see Note 5).

This document does not cover the level of residual sterilizing agent within medical devices (see Note 6).

This document does not describe a quality management system for the control of all stages of manufacture (see Note 7).

NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important.

NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.

NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.

NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process.

NOTE 5 Such testing is a crucial part of the design and development of a medical device.

NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.

NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

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.