YY 1082-2007 (English Version) PDF

Scope: This standard specifies the classification and labeling, requirements, test methods, inspection rules, signs, labels and instructions for use, packaging, transportation and storage of rigid arthroscopes. This standard applies to rigid arthroscopes (hereinafter referred to as arthroscopes). Arthroscopes are suitable for the examination and diagnosis of human joint diseases in clinical medicine, and can be treated with relevant surgical systems.

YY 1082-2007 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 0076-1992 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 1082-2007 Rigid arthroscope has been changed from YY 91082-1999 Arthroscope.