AAMI TIR56 pdf free download

AAMI TIR56 pdf free download.Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices.
4 Quality management systems
4.1 Sterilization processes employing flexible bag sterilization systems should comply with all aspects of Quality Management Systems applied to sterile device manufacturers, including requirements for documentation, management responsibility, and product realization.
4.2 Procedures for identification and traceability of product shall be specified.
4.3 A system shall be specified for the calibration of all equipment including the instrumentation for test
purposes.
5 Sterilizing agent characterization
5.1 General
The purpose of this activity is to define the sterilizing agent, demonstrate its microbicidal effectiveness, identify the factors that influence microbicidal effectiveness, assess the effects that exposure to the sterilizing agent has on materials, and identify requirements for safety of personnel and protection of the environment. This activity may be undertaken in a test or prototype system. Where this occurs, the final equipment specification should be comparable to the results of experimental studies undertaken in the test or prototype equipment. The sterilizing agent is EQ.
5.2 Sterilizing agent
The composition, storage conditions, and shelf life for the sterilizing agent should be specified.
5.3 Microbicidal effectiveness
Microbicidal effectiveness data should be developed if using a sterilant other than 100 % EQ (i.e., gas mixtures).
NOTE The inactivation of microorganisms by EQ has been comprehensively documented in the literature, therefore, reference to these general studies on microbial inactivation would not be required.
5.4 Material effects
The effects of EQ on a wide variety of materials used to manufacture medical devices have been comprehensively documented, and such documentation is of value to those designing and developing medical devices that are to be sterilized by EQ. There is no requirement to perform specific studies on material effects. AAMI TIR17:2008 provides general information on the compatibility of common medical device materials with EQ. The users of EQ flexible bag systems are responsible for assuring that the devices sterilized in these systems are compatible with the sterilant and the sterilization process to meet all required regulations.
5.5 Safety and the environment
5.5.1 A material safety data sheet or analogous safety information should be specified for the EQ.
5.5.2 The potential effect on the environment of the operation of the sterilization equipment should be assessed, and measures to protect the environment should be identified. This assessment, including potential impact and measures for control, should be documented.
5.5.3 Users of EQ should comply with applicable local, national, and international requirements regarding the emission and disposal of EQ and its diluents, as well as any by-products.
5.5.4 U.S. Department of Transportation regulations for the transport of EQ (49 CFR 173.323) and the handling and storage requirements issued by the gas supplier and sterilizer manufacturer should be followed. The gas supplier and user should abide by the U.S. Environmental Protection Agency (EPA) label instructions on the supplier’s shipping containers (Federal Insecticide, Fungicide and Rodenticide Act [FIFRA] 7 U.S.C. §136j) and U.S. Qccupational Safety and Health Administration (OSHA) process safety management (if applicable). The gas supplier’s facility and the sterilant must be registered with the EPA (FIFRA 7 U.S.C. §136a, §136a-1, and §136e). Manufacturers and gas suppliers outside of the United States should meet local regulations that are comparable to the above. Storage requirements at the facility should meet NFPA 30.AAMI TIR56  pdf download.