BS EN ISO 5364-2016 pdf download.Anaesthetic and respiratory equipment – Oropharyngeal airways (ISO 5364:2016). 5 Materials Oropharyngeal airways, in their ready-for-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in ISO 10993-1. 6 Design Edges and corners intended to come into contact with the patients tissues shall have a minimum radius of curvature of 0,5 mm. 7 Performance requirements 7.1 Resistance to collapse of the buccal portion When tested in accordance with Annex B, the minimum inside dimension of the buccal portion of the airway shall be not less than 75 % of that given in Table 1 for the size of the airway being tested. 7.2 Patency of lumen When tested in accordance with Annex C, the patency of the oropharyngeal airway lumen shall be maintained. 8 Sterility assurance Oropharyngeal airways supplied and marked “STERILE’ shall satisfy the requirements of EN 556- 1:2001,4.1. 9 Packaging of oropharyngeal airways supplied sterile 9.1 Each oropharyngeal airway supplied and marked STERILE” shall be contained in an individual pack 9.2 The pack shall serve as an effective barrier to the penetration of microorganisms and particulate material in accordance with ISO 11607-1. 9.3 The pack shall permit the aseptic extraction of the contents and shall not be capable of re-closure without clearly revealing that it has been opened. 9.4 The designated size of the airway shall be apparent on visual examination of the intact unit container. 9.5 Individual packs shall be contained within a shelf or multi-unit pack. 10 Marking 10.1 General Marking of oropharyngeal airways, of unit packs and of shelf or multi-unit packs and information to be supplied by the manufacturer should comply with EN 1041. 10.2 Use of symbols The requirements of ltL4 and 1115 may be met by use of appropriate symbols as given in ISO 7000 or ISO 15223-1. 10.3 Marking of oropharyngeal airways 10.3.1 The flanged end of the oropharyngeal airway shall be marked with the following: a) the designated size (nominal length, in centimetres) in accordance with 4.]. (see Figure 2) b) the name and/or trademark of the manufacturer and/or supplier (see Figure 2) c) an indication of the presence of natural rubber (latex), if present in the device.BS EN ISO 5364 pdf download.
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