GB 12259-1990
Abolished
YY/T 1409-2016
Active
Industry standards-Medicine
YY/T 1409-2016 Plasma surgical equipment
YY/T 1409-2016 Plasma surgical equipment
Basic Information
Standard Code:
YY/T 1409-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2016-03-23
Implement Date:
2017-01-01
Pages:
9 pages
Scope
This standard specifies the terms and definitions, components, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of plasma surgical equipment.
This standard applies to plasma surgical equipment as defined in Clause 3.1 (hereinafter referred to as "equipment"). For a multi-functional device, the content specified in this standard only applies to the plasma surgical function of the device. Other functions of the device shall comply with the requirements of other relevant standards.
Development Information
Referenced Standards
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.4-2009 Medical electrical equipment—Part 2-2:Particular requirements for the safety of high frequency surgical equipment
GB 9706.15-2008 Medical electrical equipment—Part1:General requirements for safety—1.Collateral standard:Safety requirements for medical electrical systems
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
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 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 91057
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
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced