YY 0671.1-2009 Translated English of Chinese Standard. YY0671.1-2009: Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy deviceshttps://www.chinesestandard.net, 2. kol 2017. - Broj stranica: 38 This Part of YY 0671 is a special standard based on GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety. GB 9706.1-2007 is referred to herein as a general standard. A general standard is the basic standard for the safety of medical electrical equipment used or monitored by qualified personnel in general medical and patient environments. It also includes some requirements for reliable operation to ensure safety. |
Sadržaj
Foreword | 6 |
Introduction | 8 |
Scope | 9 |
Terms and definitions | 10 |
General requirements | 13 |
Input power | 17 |
Not used | 18 |
Isolation | 19 |
Optical radiation including laser | 22 |
Requirements and tests for AP device and its components and elements | 23 |
Overflow liquid spill leak moisture liquid injection cleaning disinfection sterilization and compatibility | 24 |
Biocompatibility | 25 |
Abnormal operation and fault status | 26 |
Shell and enclosure | 27 |
Network power parts components and wiring | 30 |
Annex A Informative Basic principles | 31 |
Face corner and side | 20 |
Pneumatic and hydraulic power | 21 |
Annex B Informative Glossary | 37 |
Uobičajeni izrazi i fraze
22 mm conical according added the following Addition air resistance airflow Anaesthetic and respiratory and/or Annex apnoea breathing therapy applies basic principles breathing gas breathing pressure breathing therapy device BTPS cm H2O Conical connectors conical joint CPAP Electromagnetic compatibility ensure environment exhaust port following information fresh-gas intake port gas input port gas output port gas return port GB/T humidifiers hypopnea installation interface joint that complies manufacturer maximum pressure mbar medical devices Medical electrical equipment medical gases method minimum flammable temperature noise Noise Audio normal NOTE operation oxygen saturation parallel standards patient connection port patient leakage current port connector probe protective earth provisions of YY radiation Clause Requirements and tests requirements for safety requirements of GB respiratory equipment respiratory pressure sensor single failure single fault condition sleep apnoea breathing sound level meter sound pressure level spark energy special standard specified in YY sterilization idt ISO sub-clause tidal volume ventilation