BS EN ISO 5364:2016 pdf free download.Anaesthetic and respiratory equipment Oropharyngeal airways ( IS0 5364 : 2016).
I Scope
BS EN ISO 5364 specifies requirements for oropharyngeal airways of plastics materials and/or rubber. including those with a reinforcement insert made of plastics materials and/or metal.
BS EN ISO 5364 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
Flammability of oropharyngeal airways. for example, if flammable anaesthetics. electrosurgical units. or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management. which is outside the scope of BS EN ISO 5364.
BS EN ISO 5364 Is not applicable to supralaryngeal airways without an Internal, integral sealing mechanism.
2 Nonnative 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 7000, GraphIcal symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evahiacion of medical devices — Port 1: Evaluation and testing within a risk management process
ISO 11607-1, Packaging for terminally sterilized medical devices — Parr 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1. Medical devices — Symbols to be used with medical device labels, labelling and Information to be supplied — Part I: General requirements
EN 556-12001, Sterilization of medical devices — Requirements for medical devices to be designated S7’ERlLE’ — Parr 1: Requirements for terminally sterilized medical devices
EN 1041. Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
oropharyngeal airway
device mtended to maintain a gas pathway through the oral cavity and pharynx
[SOURCE: ISO 4135:2001,6.1.11
3.2
pharyngeal end
that end of an orophoryngeal airway (1.1) which is intended to be Inserted into a patient’s oropharynx
[SOURCE: ISO 4135:2001,6.1.1.21
4.2 DimensIons
4.2.1 The length (see!. Figure 1) shall be in accordance with Tak1J.
4.22 The minimum Inside dimension at any point along the length of the airway shall be not less than that specified In Table 1.
NOTE This dimension is relevant to the ability to pass ether devices, e.g. a suction cathetc, through the airway.
5 Materials
Oropharyngeal airways, in their ready-for-use state alter 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.
B 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 STERILr 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 ii !,07- 1.
9.3 The pack shall permit the aseptic extraction of the contents and shall not be capable of re-closure
without dearly 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 infonnation to be supplied by the manufacturer should comply with EN 1041.
10.2 Use or symbols
The requirements of ].Q4 and jfl 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 41 (see Figure 2)
b) the name and/or trademark olthe manufacturer and/or supplier (see Figure 2):
c) an indication of the presence of natural rubber (latex), if present in the device.
1 designated size
2 name and/or trademark of manufacturer or supplier
NOTE The designs shown in Figures 1 and are intended to illustrate common types of oropharyngeal airway for the purpose of size designation and marking, but are for example only.
Figure 2— Typical marking locations on flanged end of oropharyngeal airways
10.3.2 Marklngs In accordance with a) and b) shall be clearly legible from the flanged end when viewed ata distance of 500 mm * 10mm at an illuminanct• of 215 Is ± 15 lx using normal vision (corrected. if necessary).
Check compliance by visual inspection.
10.3.3 Oropharyngeal airways shall be colour cdcd by size in accordance with Table 2.
10.3.4 Colour code shall be visible from the flanged end.
b) for oropharyngeal airways not intended for re-use, the words “single use” or equivalent. c an Indication of the presence of natural rubber (latex), if present in the device.
10.5 Marking of shelf or multi-unit packs
The marking of shell or multi-unit packs shall include the following:
a) a description of contents;
b) the designated size in accordance with 41.;
c) the name and/or trademark and address of the manufacturer and/or suppIler
d) the batch number:
e) the word STERILE”, if appropriate (it is recommended that the method of sterilization be given);
f) For oropharyngeal airways not Intended For re•use, the words “single use” or equivalent.
It is strongly recommended that the “use by” date be given.
11 Information to be supplied by the manufacturer
11.1 Unless the orophaiyngeal airway is intended and marked as being for single use, the manufacturer shall recommend methods of cleaning and disinfection or sterilization.
11.2 The manufacturer shall indicate the presence of natural rubber (latex). if present in the device.