ANSI AAMI ISO 11135 pdf free download

ANSI AAMI ISO 11135 pdf free download.Sterilization of health care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices.
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 (see 6.3) shall be relatable to the results of experimental studies undertaken in the test or prototype equipment. For the purposes of this International Standard, the sterilizing agent is EQ.
5.2 Sterilizing agent
The sterilizing agent specification shall include, if appropriate, conditions of storage to maintain the EQ within its specification for the duration of the stated shelf life.
5.3 Microbicidal effectiveness
Microbicidal effectiveness data shall be developed if it is proposed to use the EQ outside of the range of compositions that are widely recognized or if a novel diluent is to be used.
NOTE The inactivation of microorganisms by EQ has been comprehensively documented in literature. This literature provides knowledge of the manner in which the process variables affect microbial inactivation. Reference to these general studies on microbial inactivation is not required by this International Standard.
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. This International Standard does not require the performance of specific studies on material effects but does require performance of studies of the effects of EQ on product (see Clause 7).
5.5 Safety and the environment
5.5.1 Either a material safety data sheet (MSDS) or analogous safety information shall be made available for EQ and its diluents (if any). Measures necessary to protect the health and safety of personnel shall be identified.
5.5.2 The potential effect on the environment of the operation of the sterilization process shall be assessed, and measures to protect the environment shall be identified. This assessment, including potential impact and measures for control, shall be documented.
5.5.3 Users of EQ shall comply with applicable local, national, and international requirements regarding the emission and disposal of EQ and its diluents, as well as any by-products.
6 Process and equipment characterization
6.1 General
6.1.1 The purpose of this activity is to define the entire sterilization process and the equipment necessary to deliver the sterilization process safely and reproducibly.
7 Product definition
7.1 General
7.1.1 The purpose of this activity is to define the product to be sterilized, including the microbiological quality of the product prior to sterilization and the manner in which product is packaged and presented for sterilization.
7.1.2 Product definition shall be performed prior to the introduction of a new or modified product, package or loading configuration. A demonstration of equivalence (with reference to the challenge to the sterilization process) to a previously validated product, package, or loading configuration shall be considered to meet the requirement to perform product definition. Any demonstration of equivalence shall be documented.
7.1.3 Product shall be designed to allow removal of air, if applicable, and penetration of heat, humidity, and EQ during the sterilization process, and removal of EQ at the end of the process.
7.1.4 Packaging shall be designed to allow removal of air and penetration of heat, humidity, and EQ during the sterilization process, and removal of EQ at the end of the process.
7.1.5 The load configuration shall be designed to allow removal of air and penetration of heat, humidity, and EQ during the sterilization process, and removal of EQ at the end of the process.ANSI AAMI ISO 11135 pdf download.