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Endoscopes
  • ISO 8600-1-2013 pdf free download.Endoscopes  – Medical endoscopes and endotherapy devices – Part 1: General requirements. 6 Marking 6.1 Minimum marking Iach individual endoscope or endotherapy device shall have the lollowing minimum marking: a) model number and/or other mark sufficient to identify the endoscope or endotherapy device and its manufacturer; b) maximum insertion portion width, minimum instrument channel width, working length, field of view and/or direction of view where such identification is necessary for the intended use of the endoscope or endotherapy device. The Insertion portion width and instrument channel width units shall be in millimetres. The insertion portion width and instrument channel width can also be marked in French size as defined in 3.5, shown by either ‘Fr or an encircled number; c) wherever reasonable and practicable. the endoscope or endotherapy device and detachable component(s) shall be identified in terms of lot numbers or serial numbers, etc. 6.2 Marking legibility The marking shall remain legible over the lifetime of the device when the endoscope or endotherapy device is used, cleaned, disinlected, sterilized and stored in accordance with the instruction manual. 6.3 Marking exceptions When marking on the endoscope or endotherapy device or detachable component(s) is impossible to achieve due…

  • ISO 8600-2-2015 pdf free.Endoscopes – Medical endoscopes and endotherapy devices – Part 2: Particular requirements for rigid bronchoscopes. This part of Iso 8600 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets ISO 8600-1:2013, Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 8600-1 and the following apply. rigid bronchoscope open straight tube-type rigid endoscope fitted with a means of illumination through the distal end and intended to be introduced into the tracheobronchial airway, having an internal lumen sufficiently large to permit free respiration of the patient 3.2 rigid ventilation bronchoscope rigid bronchoscope, fitted with a removable end-cap at the proximal end of the open straight tube and having an internal…