- Standard No.
- GB 9706.212-2020
- Language
- Chinese
- Release Date
- 2020
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Lastest
-
GB 9706.212-2020
- Replace
-
GB 9706.28-2006
- Scope
- Subsection 1.1 of GB 9706.1-2020 is replaced by the following: --- This part applies to the basic safety and essential performance of ventilators used in combination with their accessories, hereinafter also referred to as ME equipment: intended for use on patients dependent on mechanical ventilation, and attended by a professional operator; and Note 1 to entry: This type of ventilator is considered life-supporting ME EQUIPMENT or ME SYSTEM. --- It is intended to be used in the emergency care environment of professional medical establishments, or it is expected to be used for transfer in professional medical establishments. Note 2: Intensive care ventilators used for transport in professional medical settings are not considered as emergency and transport ventilators. The provisions of this section also apply to the manufacturer intended to be connected to the VBS or connected to the ventilator accessories, and the characteristics of such accessories may affect the basic safety and basic performance of the ventilator. This standard does not apply to ME EQUIPMENT and ME SYSTEMS operating in the ventilation mode used by patients not dependent on mechanical ventilation. NOTE 3 Critical care operating in the above modes is not considered life-supporting ME EQUIPMENT or ME SYSTEM. If a clause or clause clearly states that it applies only to ME EQUIPMENT, or only to ME SYSTEMS, the title and the text of the clause or clause will state that. If not expressly stated, the relevant clauses or clauses apply to both ME EQUIPMENT and ME SYSTEMS. Except 7.2 in GB9706.1-2020.
GB 9706.212-2020 Referenced Document
- GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane
GB 9706.212-2020 history
- 2020 GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- 2006 GB 9706.28-2006 Medical electrical equipment.Part 2:Particular requirements for the safety of lung ventilators.Critical care ventilators
GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators has been changed from GB 9706.28-2006 Medical electrical equipment.Part 2:Particular requirements for the safety of lung ventilators.Critical care ventilators.