ISO/TS 22421 pdf free download
ISO/TS 22421-2021 pdf free download.Sterilization of health care products一 Common requirements for steri lizers 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 classified 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 pre-set 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 resources, including competent human resources and infrastructure;
— control of product, including services, provided by external parties;
— calibration of instrumentation.
NOTE 1 ISO 13485 covers all stages of the lifecycle of medical devices in the context of quality management systems for regulatory purposes. National or regional regulatory requirements for the provision of health care product can require the implementation of a full quality management system and the assessment of that system by a recognized conformity assessment body.
NOTE 2 ISO 14971 provides requirements for a risk management system for medical devices.
NOTE 3 ISO 12100 provides requirements for risk management of machinery.
4.3 Calibration
4.3.1 Instrumentation on the sterilizer and instruments used for test purposes shall be calibrated. The system(s) for calibration of instrumentation shall provide metrological traceability to a primary standard or national standard with a known level of measurement uncertainty.
NOTE National calibration standards are often mutually recognized and traceable to international standards with recognized fixed-points.
Conformance is demonstrated by inspection of the technical documentation.
4.3.2 Means shall be provided to permit connection of reference instruments for the calibration of instrumentation.
Conformance is demonstrated by inspection.
5 Equipment design and construction
5.1 Safety and security
5.1.1 The sterilizer shall conform with IEC 61010-2-040.
NOTE IEC 61010-2-040 provides safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields.
Conformance is demonstrated in accordance with IEC 61010-2-040.
5.1.2 Sterilizers shall conform with IEC 61326-1 regarding immunity to electromagnetic interference.
The immunity performance criteria selected shall ensure that sterilizer performance is met when exposed to the applicable disturbance phenomena of IEC 61326-1.
Conformance is demonstrated in accordance with IEC 61326-1.
5.1.3 Sterilizers shall incorporate means of protection from unauthorized access that could interfere with its performance or create a hazardous situation. If the sterilizer provides a connection to an IT environment or network, means shall be provided to prevent access or interaction:
a) between that environment or network and the sterilizer that interferes with the sterilizer performance or creates a hazardous situation;
h) between the sterilizer and that environment or network protocol(s) that interferes with the specified performance of the environment or network.ISO/TS 22421 pdf download.
