GB 9706.8-1995
Replaced
YY 0071-2008
Replaced
Industry standards-Medicine
YY 0071-2008 Sigmoidoscopy and rectoscopy set
YY 0071-2008 Sigmoidoscopy and rectoscopy set
Basic Information
Standard Code:
YY 0071-2008
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Medical equipment
Publish Date:
2008-04-25
Implement Date:
2009-12-01
Pages:
9 pages
Scope
This standard specifies the classification, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage requirements for rectal and sigmoid colon endoscopes. This standard applies to rectal and sigmoid colon endoscopes (hereinafter referred to as endoscopes), which are mainly used to examine lesions in the anorectal region and/or assist in treatment with conventional surgical instruments. This standard does not apply to endoscopes with optical systems.
Development Information
Replace the following standards
Superseded by the following standards
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.19-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of endoscopic equipment
GB/T 14975-2002 Stainless steel seamless tubes for structures
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
YY 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
国家食品药品监督管理局令第10号 医疗器械说明书、标签和包装标识管理规定
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced