ISO/TS 22421-2021 pdf download

ISO TS 22421-2021 pdf download.Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities. 4 General 4.1 Product definition 4.1.1 When demonstrating that a sterilizer type conforms with this document, sterilizers dassihed as the same type shall have the same intended use with the same sterilizing agent specification. In addition. unless it has been demonstrated that there is no decrease in the performance of an operating cycle, a sterilizer type shall have: a) the same number of loading or unloading doors; b) all service connections into the chamber in the same orientation; c) the same control system with all fixed sensors located in the same position and orientation; d) the same preset programmes of operating cycle(s) including the same cycle parameters. NOTE I A mirror image of the original orientation does not constitute a new type. NOTE 2 Where change within the control system does not affect the sequence of stages of the sterilization cycle, and the parameters limiting the cycle performance, or the safety attributes, such a change does not constitute a new type. Conformance is demonstrated by inspection of the technical documentation. 4.1.2 If all other design aspects remain the same, the following variations shall not constitute a new sterilizer type: a) height of the sterilizer chamber above the floor; b) differences in the dimensions of the sterilizer chamber not greater than ±10 % of the dimensions with congruent sterilizer chamber shapes; c) prolonging the duration of the exposure phase of an operating cycle; NOTE Additional regulatory requirements can apply to prolonging the exposure phase. d) prolonging desorption, cooling or drying after the exposure phase; e) any change of the design or provenance of equipment, providing there is available documented evidence to show there is no decrease in the safety or performance of the sterilizer which can affect conformance with this document. Conformance is demonstrated by inspection of the technical documentation. 4.2 Equipment development The design and development process is a critical element in product realization of a sterilizer. To ensure the consistent implementation of the requirements specified in this document, the necessary processes need to be established, implemented and maintained. Processes of particular importance in relation to the design and development of a sterilizer include but are not limited to: — risk management; — control of documentation, including records; — assignment of responsibility; — provision of adequate...