Detaljer om förslaget

Svensk titel: Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Nummer:prEN ISO 14160
Källa:CEN
Kommitté:SIS/TK 349
Namn på kommittén:Rengöring, desinfektion och sterilisering
Publicerat:den 2 maj 2018
Sista svarsdatum:den 25 jun 2018
Contact email:kommentera(at)sis.se
Förslagets omfattning:

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.

Detta dokument föreslås att fastställas och publiceras som svensk standard.

För att lämna allmänna kommentarer på standardförslaget i sin helhet och på föreslagen titel – klicka på förslagets titel i innehållsförteckningen till vänster.

För att lämna specifika kommentarer på innehållet – skriv kommentaren och föreslagen ändring i rutan under avsnittet i fråga.

Standardförslag på engelska föreslås att fastställas som svensk standard utan översättning. Kommentarer på engelskspråkiga standardförslag bör vara på engelska.

För att ett standardförslag ska kunna fastställas som svensk standard måste det vara förenligt med svensk lagstiftning. Det är således viktigt att berörda svenska myndigheter klarlägger ifall standardförslaget är förenligt med svensk lagstiftning.