This standard specifies the terms and definitions, requirements, test methods, inspection rules, markings, instructions for use, packaging labeling, packaging, transportation, storage and other requirements for high-frequency jet ventilators (hereinafter referred to as ventilators). This standard applies to medical high-frequency jet ventilators that are open for both exhalation and inhalation. This device is suitable for patients with respiratory support, respiratory therapy and emergency resuscitation, and can be used under the supervision of medical staff.
YY 0042-2007 Referenced Document
GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
GB 9969.1-1998 General principles for preparation of instructions for use of industrial products
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 191-2000 Packaging-Pictorial marking for handling of goods
GB/T 4999-2003 Anaesthetic and respiratory equipment vocabulary
YY 1040.1-2003 Anaesthetic and respiratory equipment-Conical connectors-Part 1:Cones and sockets