GB 9706.255-2022
Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (English Version)

Standard No.

GB 9706.255-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 9706.255-2022

Scope

RGM used in laboratory research applications are usually experimental or primarily intended for non-medical use. Imposing the requirements of this document on RGMs used for research may unduly limit the development of beneficial new technologies or RGM designs. Preventing unintended awakenings under general anesthesia has been a thorny issue. Typically, these events occur when an anesthetic delivery device is run off-load or turned off intentionally while the patient is being relocated, and is inadvertently not turned back on. The data and alarm status of the RGM are useful aids in discovering these events. Unfortunately, this information is usually not available through electronic interfaces. However, the development of intelligent distributed alarm systems can build the ability to warn operators of these conditions. RGM data is also necessary to create a complete and accurate electronic medical record. Therefore, RGM manufacturers are encouraged to establish such data access for third parties through open, standards-based electronic data interfaces. 201.

GB 9706.255-2022 Referenced Document

• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• GB 9706.213-2021 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation
• GB/T 19974 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
• 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 4208 Degrees of protection provide by enclosure (IP code)
• IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
• ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
• YY 9706.102 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests
• YY 9706.108-2021 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standards: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems
• YY 9706.111-2021 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems used in home care environments
• YY 9706.112-2021 Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envir
• 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
• YY/T 0802 Disposal of medical devices Information provided by medical device manufacturers
• YY/T 0916.20-2019 Small bore connections for medical liquids and gases - Part 20: General test methods
• YY/T 0916.3-2022 Small bore connectors for medical liquids and gases Part 3: Connectors for gastrointestinal applications
• YY/T 0916.6-2022 Small bore connectors for medical liquids and gases - Part 6: Connectors for axonal applications
• YY/T 9706.106 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standards: Availability

GB 9706.255-2022 history

• 2022 GB 9706.255-2022 Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

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