IS/ISO 11712 : 2009 : Anaesthetic and Respiratory Equipment Supralaryngeal Airways and Connectors

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 11712 : 2009 ‘Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

A supralaryngeal airway is a device placed through the mouth, intended to seal the supralaryngeal area to maintain airway patency without passing through the vocal cords and to independently facilitate ventilation with or without delivery of anaesthesia gases. Devices intended to provide a breathing airway and/or to simultaneously provide a guide for the intubation of tracheal tubes, bronchoscopes and suction devices are also included in the scope of this Indian Standard, as are the connectors inserted into the machine end of these devices.

Examples of supralaryngeal airway devices are laryngeal masks, laryngeal tubes, airways and seals, cuffed oropharyngeal airways, and pharyngeal airways, and combination airway/esophageal obturators.

The requirements of this standard were developed using the hazard identification for risk assessment in Annex D.

The requirements for testing and disclosure apply to devices introduced to the market after the publication of this standard.

The terms defined in this standard appear in bold type.

In this standard the text for which a rationale is provided in Annex A is indicated by an asterisk (*)

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.