ČAS vydala aktuální věstník změn v ČSN pro březen 2024

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Vydal: Úřad pro technickou normalizaci, metrologii a státní zkušebnictví

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active devices -3. active non-implantable therapeutic devices and general active non-implantable devices -mda 0312 other active non- implantable surgical devices Conformity assessment based quality management system Conformity assessment based on assessment technical documentation Conformity assessment based product quality assurance Annex IX(I) Annex IX(II) Annex XI(A) except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices -i. active devices -3. codes reFlecting the design and intended purpose oF the device -a. active devices -3. active non-implantable therapeutic devices and general active non-implantable devices -mda 0302 active non- implantable devices utilising non- ionizing radiation Conformity assessment based quality management system Conformity assessment based on assessment technical documentation Conformity assessment based product quality assurance Annex IX(I) Annex IX(II) Annex XI(A) except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices -i. active devices -3. codes reFlecting the design and intended purpose oF the device -a. codes reFlecting the design and intended purpose oF the device -a. active devices -3. active non-implantable therapeutic devices and general active non-implantable devices -mda 0305 active non- implantable devices for stimulation or inhibition Conformity assessment based quality management system Conformity assessment based on assessment technical documentation Conformity assessment based product quality assurance Annex IX(I) Annex IX(II) Annex XI(A) except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices -i. active non-implantable therapeutic devices and general active non-implantable devices -mda 0315 software Conformity assessment based quality management system Conformity assessment based on assessment technical documentation Conformity assessment based product quality assurance Annex IX(I) Annex IX(II) Annex XI(A) except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices page. codes reFlecting the design and intended purpose oF the device -a.Věstník 3/2024 45 Products Procedures Articles /Annexes Conditions -i. active non-implantable therapeutic devices and general active non-implantable devices -mda 0307 active non- implantable respiratory devices Conformity assessment based quality management system Conformity assessment based on assessment technical documentation Conformity assessment based product quality assurance Annex IX(I) Annex IX(II) Annex XI(A) except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices -i. codes reFlecting the design and intended purpose oF the device -a