GB 11246-1989
Abolished
T/CSBME 077-2023
Active
Group standards
T/CSBME 077-2023 Disposable Bronchial Blocker
T/CSBME 077-2023 Disposable Bronchial Blocker
Price:
$ 29.00
Basic Information
Standard Code:
T/CSBME 077-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2023-12-29
Implement Date:
2024-03-01
Pages:
12 pages
Scope
This document specifies the technical requirements, test methods, marking, packaging, transportation, and storage for single-use bronchial occluders (hereinafter referred to as "bronchial occluders"). This document is applicable to single-use bronchial occluders used by medical units during thoracic surgery to implement one-lung ventilation.
Development Information
Referenced Standards
GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
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 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
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 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
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
中华人民共和国药典(2020年版)
Related Standards
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