AAMI ISO 11607 pdf free download

AAMI ISO 11607 pdf free download.Packaging for terminally sterilized medical devices.
3.12 microbial barrier: Attribute of the packaging system that prevents the ingress of microorganisms under specified conditions. NOTE—In EN 868-1 the definition of this term differs slightly. 3.13 package integrity: Unimpaired physical condition of a final package. 3.14 packaging compatibility: Attribute of the packaging material and/or system to allow it to achieve the required performance without detrimental effect on the medical device during transport, storage, or use. 3.15 packaging material: Any material used in the fabrication or sealing of a packaging system or primary package. 3.16 packaging system: One or more packaging materials assembled into a single unit intended as part or all of a primary package. 3.17 performance qualification: Documented evidence that packaging meets the appropriate requirements for sterile packaging based on testing of the particular packaging material for compliance with the applicable requirements of this International Standard. 3.18 primary package: Sealed or closed packaging system that forms a microbial barrier, enclosing a medical device. 3.19 producer: Natural or legal person, individual, or organization with the responsibility for manufacturing the packaging material and/or system. 3.20 product: Combination of both the medical device and/or additional components with the final package. 3.21 qualification: Documented evidence that all specified design and performance requirements are met. 3.22 revalidation: Documented procedure to reconfirm an established validation.3.27 sterile fluid-path packaging: System of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids. 3.28 sterilization compatibility: Attributes of the packaging material and/or system that allow it to both withstand the sterilization process and attain the required conditions for sterilization within the final package. 3.29 terminally sterilized: Term for medical devices that are sterilized after being completely sealed or enclosed in at least the primary package. 3.30 user: Natural or legal person, individual, or organization having the responsibility for making use of the product. 3.31 validation: Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. NOTE—Validation is considered to be a total process that includes written protocol, evidence that the equipment as installed meets design criteria and specifications (equipment qualification), use of calibrated instruments to collect data, and evidence that the equipment can deliver the process within specified tolerances under established operating conditions and is reproducible as demonstrated by replicate runs and process challenges (process performance qualification).4.2 Sampling The sampling plans used for selection and testing of packaging materials and/or system shall be chosen by agreement between the producer and manufacturer, e.g. acceptable quality limit (AQL) in accordance with ISO 2859- 1 or ISO 1 86:2002, or statistical process control (SPC). For each plan chosen, a rationale shall be documented. 4.3 Test methods 4.3.1 All test methods used to show compliance with this International Standard shall be validated. The selection of test methods, the variables to be determined, and the acceptance criteria shall be documented. 4.3.2 For some of the requirements, internationally accepted standardized test methods may be available. The use of these test methods is recommended, but these methods, as well as any other applied methods, shall be validated and documented. Unless otherwise specified in the test methods for materials, test samples should be conditioned in accordance with ISO 1 87 at (23 + 1 ) °C and (50 + 2) % relative humidity. NOTE 1—For compliance with EN 868-1 , the above becomes a requirement (EN 868-1 :1 997, 5.2). NOTE 2—The test methods listed in annexes B and C of this International Standard do not eliminate the need for validation nor do they exclude other validated test methods.AAMI ISO 11607 pdf download.