GB 9706.212-2020
Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (English Version)

Standard No.

GB 9706.212-2020

Language

Chinese, Available in English version

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

Latest

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 50751 Technical code for medical gases engineering
• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
• GB/T 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
• GB/T 2423.5-2019 Environmental testing—Part 2: Test methods—Test Ea and guidance: Shock
• GB/T 2423.56-2018 Environmental Testing Part 2: Test Methods Test Fh: Broadband Random Vibration and Guidelines
• GB/T 31523.1-2015 Safety information identification systems.Part 1:Signs
• 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/T 4999 Anaesthetic and respiratory equipment vocabulary
• YY 0339-2009 Suction catheter for use in the respiratory tract
• YY 0461 Breathing tubes intended for use with aneasthetic apparatus and ventilators
• YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
• YY 0601 Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors
• YY/T 0466.1-2016 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements

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.

GB 9706.212-2020 -All Parts