GB 12259-1990
Abolished
YY 0650-2008
Active
Industry standards-Medicine
YY 0650-2008 Gynecological radio frequency therapy instrument
YY 0650-2008 Gynecological radio frequency therapy instrument
Basic Information
Standard Code:
YY 0650-2008
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:
2008-04-25
Implement Date:
2009-12-01
Pages:
11 pages
Scope
This standard specifies the definition, classification, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of gynecological radiofrequency therapy devices.
This standard applies to the gynecological radiofrequency therapy devices defined in 3.1 (hereinafter referred to as the therapy devices), which are used for the surgical treatment of gynecological-related diseases.
Development Information
Superseded by the following standards
Referenced Standards
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.15-1999 Medical electrical equipment—Part 1:General requirements for safety 1.Collateral standard:Safety requirements for medical electrical systems
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 19633-2005 Packaging for terminally sterilized medical devices
YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 91057
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
GB 9706.4-2009 Medical electrical equipment—Part 2-2:Particular requirements for the safety of high frequency surgical equipment
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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