novocure Optune NovoTTF 200A, User Manual

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 EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation
and testing
 EN ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in-
vitro cytotoxicity
 EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed type hypersensitivity
 EN ISO 10993-12– Biological evaluation of medical devices – Part 12: Sample
preparation and reference materials
 EN 556-1 - Sterilization of medical devices - Requirements for medical devices
to be designated "Sterile" - Part 1: Requirements for terminally sterilized
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 ISO 11137-1 Sterilization of healthcare products –radiation – Part 1:
Requirements for development, validation and routine control of a sterilization
process for medical devices.
 EN ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2:
Establishing the sterilization dose.
 ISO 11137-3 Sterilization of health care products -- Radiation -- Part 3:
Guidance on dosimetric aspects of development, validation and routine control.
 EN ISO 11737-1 Sterilization of medical devices -- Microbiological methods --
Part 1: Determination of a population of microorganisms on products.
 ISO 11737-2 Sterilization of medical devices -- Microbiological methods -- Part
2: Tests of sterility performed in the definition, validation and maintenance of a
sterilization process
 ISO 14644-1 Cleanrooms and associated controlled environments--Part 1:
Classification of air cleanliness by particle concentration.
Charger for portable batteries complies with the latest edition of the following
standards:
 EN 61000-6-1 - Electromagnetic compatibility (EMC) – Part 6-1: Generic
standards
Immunity for residential, commercial and light-industrial environments
 EN 61000-6-3 - Electromagnetic compatibility (EMC) – Part 6-3:
Generic standards – Emission standard for residential, commercial and light-
industrial environments
 IEC 60950-1 - Information technology equipment – Safety, Part 1: General
requirements