YY 0619-2007
Rigid resectosocope (English Version)

Standard No.
YY 0619-2007
Language
Chinese, Available in English version
Release Date
2007
Published By
Professional Standard - Medicine
Status
 2018-01
Replace By
YY/T 0619-2017
Latest
YY/T 0619-2017
Scope
This standard specifies the classification and marking, requirements, test methods, inspection rules, signs, labels and instructions for use, packaging, transportation and storage of rigid electrocoagulation cutting endoscopes. This standard applies to rigid electrocoagulation cutting endoscopes (hereinafter referred to as resectoscopes). The resectoscope is suitable for clinical medical examination and uses the thermal effect of high-frequency current to perform cutting, coagulation and other operations on diseased tissues.

YY 0619-2007 Referenced Document

  • GB 11244-2005 General requirements for the medical endoscope and endoscope accessories
  • 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 9706.4-1999 Medical electrical equipment 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 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
  • GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
  • GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
  • 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/T 6463-2005 Metallic and other inorganic coatings-Review of methods of measurement of thickness
  • YY 0068 General technical requirements for endoscope rigid tube
  • YY 0076-1992 Coating classifications for metal product Technical conditions
  • YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied

YY 0619-2007 history

YY 0619-2007 Rigid resectosocope was changed to YY/T 0619-2017 Medical Endoscope Rigid Coagulation Cutting Endoscope.

Rigid resectosocope



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