GB 11533-1989
Replaced
YY/T 0788-2010
Active
Industry standards-Medicine
YY/T 0788-2010 Ophthalmic instruments—Microkeratome
YY/T 0788-2010 Ophthalmic instruments—Microkeratome
Basic Information
Standard Code:
YY/T 0788-2010
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2010-12-27
Implement Date:
2012-06-01
Pages:
12 pages
Scope
This standard specifies the classification, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage of miniature corneal cutters for ophthalmic instruments.
This standard applies to miniature corneal cutters for ophthalmic instruments (hereinafter referred to as miniature corneal cutters), which are mainly used in different levels of corneal refractive surgery and corneal transplantation surgery. This standard does not include requirements for blades.
Development Information
Referenced Standards
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB 4824-2004 Industrial, scientific and medical(ISM) radio-frequency equipment—Electromagnetic disturbance characteristics—Limits and methods of measurement
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9969.1-2008
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB 17625.1-2003 Electromagnetic compatibility—limits—Limits—for harmonic current emissions(equipment input current≤16A per phase
GB/T 17625.2-2007 Electromagnetic compatibility (EMC)—Limits—Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
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 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
Related Standards
GB/T 14148-1993
Replaced
GB/T 14148-1993 Glass blank of ophthalmic lenses
GB/T 14214-1993
Replaced
GB/T 14214-1993 Spectacle frames
GB 10810-1996
Replaced
GB 10810-1996 Spectacles lenses
GB 17342-1998
Replaced
GB 17342-1998 Ophthalmic instrument—Trial case lenses
GB 13511-1999
Replaced