ISO DIS 25424

Description / Abstract: Inclusions

This International Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.

NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.

This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).

This International Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.

Exclusions

This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.

This standard does not specify requirements for designating a medical device as “STERILE”. Such requirements are given in EN 556-1.

This standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.

This standard does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.

NOTE 1 Safety requirements for sterilizers are specified in IEC 61010-2-040.

NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirement

This International Standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.

NOTE 1 Attention is drawn to EN 14180.

NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the level of formaldehyde residues on medical devices and products.

This International Standard does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.

NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).