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ISO 8600-2-2015 pdf free
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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 lumen sufficiently large to permit ventilation of the patient through an integral ventilation connector
3.3 rigid jet ventilation bronchoscope
rigid bronchoscope provided with a jet-injector
Note 1 to entry: Rigid bronchoscopes provided with only a gas nipple should not be included within the category of jet-ventilation bronchoscopes. because the Venturi principle does not necessarily function sufficiently to ventilate the patient.
3.4 ventilation connector
breathing system connector
integral part of a rigid-ventilation bronchoscope that permits connection to a breathing system of an anaesthetic or breathing machine
4 Requirements
4.1 General
Rigid bronchoscopes shall comply with the requirements specified in Iso 8600-1. In addition, rigid bronchoscopes shall also comply with the requirements specified in 42 and 45 rigid-ventilation bronchoscopes shall also comply with the requirements specified in ±L3 and rigid jet-ventilation bronchoscopes shall also comply with the requirements specified in 44.
4.2 Dimensions
4.2.1 Working length
The actual working length of a rigid bronchoscope shall be at least as long as, and not more than, 10 mm longer than the working length stated in the instructions for use provided by the manufacturer.
4.2.2 Total length
The total length shall be in the range ±10 mm to the length stated in instructions for use.
4.2.3 MaxImum Insertion portion width
The maximum insertion portion width shall be in the range ±1 mm stated in the instructions for use provided by the manufacturer.ISO 8600-2 pdf free download.


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