Helsevesen, teknikk

Komité: CEN/TC 23 (Transportable gas cylinders)
Opprinnelse:
Sluttdato: 9. apr 2020
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Komité: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Opprinnelse:
Sluttdato: 15. apr 2020
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Komité: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Opprinnelse:
Sluttdato: 16. apr 2020
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Komité: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Opprinnelse:
Sluttdato: 16. apr 2020
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Komité: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Opprinnelse:
Sluttdato: 17. apr 2020
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Komité: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Opprinnelse:
Sluttdato: 20. apr 2020
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Komité: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Opprinnelse:
Sluttdato: 20. apr 2020
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Komité: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Opprinnelse:
Sluttdato: 20. apr 2020
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Komité: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Opprinnelse:
Sluttdato: 20. apr 2020
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Komité: ISO/TC 210 (Quality management and corresponding general aspects for medical devices)
Opprinnelse:
Sluttdato: 22. apr 2020
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Komité: ISO/TC 121/SC 3 (Respiratory devices and related equipment used for patient care)
Opprinnelse:
Sluttdato: 10. mai 2020
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Komité: ISO/TC 121/SC 2 (Airways and related equipment)
Opprinnelse:
Sluttdato: 11. mai 2020
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Komité: ISO/TC 121/SC 2 (Airways and related equipment)
Opprinnelse:
Sluttdato: 11. mai 2020
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Komité: CEN/TC 215 (Respiratory and anaesthetic equipment)
Opprinnelse:
Sluttdato: 11. mai 2020
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This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use. Not included within the scope of this particular standard are: a) Invasive tissue or vascular oximeters b) Device measuring dissolved oxygen c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered by this standard.