YY/T 0671-2021
Active
Industry standards-Medicine
YY/T 0671-2021 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories
YY/T 0671-2021 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories
Price:
$ 50
Basic Information
Standard Code:
YY/T 0671-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2021-09-06
Implement Date:
2024-05-01
Pages:
28 pages
Scope
This standard applies to the connection of sleep apnea treatment devices to patients' face masks and their accessories. This standard details the requirements for face masks and accessories, including any connectors (such as nasal masks, exhaust ports, and headbands) needed to connect the patient to the sleep apnea treatment device.
The requirements for sleep apnea treatment devices are specified in YY 9706.270. This standard and YY 9706.270 constitute two parts of the sleep apnea treatment system, and the typical components involved are shown in Figure A.1.
This standard does not include requirements for oral appliances.
Development Information
Replace the following standards
Referenced Standards
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 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
ISO 3744:2010
GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 14574-2000 Acoustics—Declaration and verification of noise emission values of machinery and equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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 19974-2018 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
YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use—Part 1:Salt test method to assess filtration performance
YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use—Part 2:Non-filtration aspects
YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors
YY 9706.270-2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Adopt standards
ISO 17510:2015
Related Standards
GB 11246-1989
Abolished
YY 0339-2002
Replaced
YY 0339-2002 Suction catheter for use in the respiratory tract
YY/T 0337.1-2002
Active
YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors
YY/T 0337.2-2002
Active
YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube
YY/T 0338.1-2002
Replaced
YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults
YY/T 0338.2-2002
Replaced