YY 1075-2007 (English Version) PDF

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 hysteroscopes. This standard applies to rigid hysteroscopes (hereinafter referred to as hysteroscopes). Hysteroscopy is mainly used in medical clinical diagnosis and treatment of uterine cavity diseases with surgical instruments. This standard does not apply to high-frequency resection hysteroscopy.

YY 1075-2007 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/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 Coating classifications for metal product Technical conditions
YY 0466 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied

YY 1075-2007 Rigid hysteroscope has been changed from YY 91075-1999 .