YY 0600.2-2007
Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 2:Home care ventilators for ventilator-dependent patients (English Version)

Standard No.

YY 0600.2-2007

Language

Chinese, Available in English version

Release Date

2007

Published By

Professional Standard - Medicine

Status

Be replaced 2024-05

Replace By

YY 9706.272-2021

Latest

YY 9706.272-2021

Scope

Except for the following parts, Chapter 1 of GB 9706.1-2007 applies to modifications: This part of YY 0600 specifies the requirements for home ventilators used by patients who rely on ventilators. This device is suitable for patients who rely on ventilatory support. This type of equipment is life support equipment, where the power source is often unreliable and is often used under the supervision of non-medical personnel with varying degrees of training. This part of YY 0600 does not apply to iron armor and "iron lung" ventilators. This part of YY 0600 does not apply to ventilators used only to increase ventilation in spontaneously breathing patients. If the requirements of this part of YY 0600 replace or modify the requirements of the general standard, the requirements shall take precedence over the corresponding general requirements.

YY 0600.2-2007 Referenced Document

• GB 7144-1999 Coloured cylinder mark for gases
• GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
• GB/T 19974-2005 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 4999-2003 Anaesthetic and respiratory equipment vocabulary
• GB/T 5332-1985 Method of test for ignition temperature of flammable liquids and gases
• ISO 15001 Anaesthetic and respiratory equipment - Compatibility with oxygen*， 2010-06-01 Update
• ISO 21647 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors; Technical Corrigendum 1
• ISO 5356-2 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors AMENDMENT 1*， 2012-01-01 Update
• ISO 5359 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases AMENDMENT 1*， 2014-01-01 Update
• ISO 5362 Anaesthetic reservoir bags
• ISO 7396-1 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum AMENDMENT 1*， 2016-01-01 Update
• ISO 8185 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems*， 2007-07-01 Update
• ISO 9360-1 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
• ISO 9360-2 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
• ISO 9919 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
• YY 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators
• YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
• YY 1040.1-2003 Anaesthetic and respiratory equipment-Conical connectors-Part 1:Cones and sockets
• YY/T 0316-2003 Medical devices-Application of risk management to medical devices

YY 0600.2-2007 history

• 2021 YY 9706.272-2021 Medical electrical equipment Part 2-72: Specific requirements for basic safety and essential performance of household ventilators for use by ventilator-dependent patients
• 2007 YY 0600.2-2007 Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 2:Home care ventilators for ventilator-dependent patients

YY 0600.2-2007 Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 2:Home care ventilators for ventilator-dependent patients was changed to YY 9706.272-2021 Medical electrical equipment Part 2-72: Specific requirements for basic safety and essential performance of household ventilators for use by ventilator-dependent patients.