Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans
|Publication Date:||15 March 1993|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
1.1 This specification covers ventilatory resuscitators, that is, small portable ventilators intended to be used in emergencies both outside and inside hospitals. These devices are intended for use by medical personnel and for emergency use by personnel with varying degrees of training. They are intended to be used at the site of an emergency and during patient transport. Resuscitators intended for use on all age groups are included within the scope of this specification.
1.1.1 This specification does not intend to discourage or impede future innovation or development of resuscitators.
1.2 The effective and safe use of a resuscitator is determined not only by the performance of the resuscitator, but also by the skill of the operator. This specification does not describe the content of the training programs to develop such skill and does not state who should or should not use a resuscitator. This will be determined by the organizations involved in teaching resuscitation.
1.2.1 In certain countries, resuscitators are intended for use by nontrained personnel and lower pressure limits are set. Some countries also reserve the use of automatic gas-powered resuscitators to trained individuals under medical supervision. This specification is not intended to conflict with these established practices.
1.3 Annex A1 details test methods, while Annex A2 provides tables of resistances and compliances required to set up the test lung. Annex A3 gives a rationale for various clauses in this specification and is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been given. Annex A4 and Annex A5 provide advice concerning materials to be used in resuscitators and face masks.
1.4 The values stated in SI units are to be regarded as the standard.
1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.