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C.B.M. - Model Standards - Container System
CBM is the only producer able to offer such an extensive assortment of dimensions, materials and different filtering systems, as well as a wide selection of accessories, conforming to the quality requirements of European norms.
European Regulation (UE) 2017/745
Medical Devices
European Directives.
2007/47/CE and 93/42/CE
Medical Devices.
EN ISO 9001
Quality management systems.
Requirements.
EN ISO 13485
Medical devices.
Quality management systems.
Requirements for regulatory.
EN ISO 17665-1
Sterilization of health care products.
Moist heat.
Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
EN ISO 11607-1
Packaging for terminally sterilized medical devices.
Part 1: Requirements for materials, sterile barrier systems and packaging systems.
EN ISO 11607-2
Packaging for terminally sterilized medical devices.
Part 2: Validation requirements for forming, sealing and assembly processes.
EN 868-8
Packaging for terminally sterilized medical devices.
Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285.
Requirements and test methods.
EN ISO 11140-1
Sterilization of health care products.
Chemical indicators.
Part 1: General requirements.
EN 285
Sterilization.
Steam sterilizers.
Large sterilizers.