Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 3:Emergency and transport ventilators
1Key Takeaways
Note: See the instructions in Appendix AA. This part is a special standard based on GB 9706.1 "Medical Electrical Equipment Part 1: General Safety Requirements". As stated in 1.3 of GB 9706.1, the requirements of this section are more effective than the relevant requirements of GB 9706.1. If a provision of GB 9706.1 is…
2Scope / Description
Note: See the instructions in Appendix AA. This part is a special standard based on GB 9706.1 "Medical Electrical Equipment Part 1: General Safety Requirements". As stated in 1.3 of GB 9706.1, the requirements of this section are more effective than the relevant requirements of GB 9706.1. If a provision of GB 9706.1 is stated to be applicable in this section, it means that the provision is applicable only when the proposed requirements are relevant to the emergency and transport ventilator under consideration. This part has common requirements with GB 9706.28 "Medical Electrical Equipment Part 2: Special Requirements for Ventilator Safety and Therapeutic Ventilators". The scope and purpose given in Chapter 1 of GB 9706.1-2007 are applicable, but 1.1 should be modified as follows: This part specifies the requirements for portable ventilators used in emergencies and when transporting patients. Portable ventilators for first aid and transport (hereinafter referred to as "ventilators") are often installed on ambulances or other rescue vehicles, but are also often used outside the vehicle and must be carried by the operator or other personnel. These devices are often used outside the hospital or at home by personnel with varying degrees of training. This section also applies to ventilators that are fixedly installed on ambulances or aircraft. This section does not apply to artificial respirators (such as artificial resuscitators).