Health Care and Medical Devices
This Standard applies to packages for consumer products available in liquid or solid form that incorporate reclosable child-resistant features that restrict children’s ability to gain access to the contents of the packages. Such packages include (but are not limited to) packages with a continuous-thread, lug-finish, or snap closure. The extent of the scope of this Standard encompass procedures and requirements for the child-resistant effectiveness, senior- adult-use effectiveness, and senior-adult reclosing test.
The ISO 11138 series of Standards specifies general production, labelling, and performance requirements for the manufacture of biological indicators. These Standards provide detailed information on the qualification of biological indicators, but only limited information for the health care professional on the use of biological indicators.
In contrast, CAN/CSA-Z11138-7 contains much useful information on the use of biological indicators, although this information is presented in a manner that might not be easily understood by the health care professional.
Accordingly, this Annex attempts to present the information contained in CAN/CSA-Z11138-7 in a manner that can be easily interpreted and to address common questions about the use of biological indicators
This is an Adopted ISO Standard.
ISO 11137-4 provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
Adoption of ISO 11737-2-2019, Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Adoption of ISO 11607-1-2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
The ISO 11607-2 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
This Standard provides guidance for a consistent approach on how to plan and conduct a study to evaluate different HCF design features while ensuring that the resources required and level of rigour match the undertaking. The focus of these studies should be aligned with the objectives of the funding agency or study sponsor to address HCF planning or design issues or to learn from elements of the completed projects to inform future projects. The studies can include planning, design, and construction (PDC) studies and post-occupancy evaluations (POE).