YY 0868-2011 (English Version) PDF

Scope: This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of electrodes for nerve and muscle stimulators (hereinafter referred to as electrodes). This standard applies to the electrodes specified in 3.1. This standard does not apply to electroacupuncture, acupuncture, electrodes that only have the function of acupuncture in traditional Chinese medicine, etc.

YY 0868-2011 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
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 191-2008 Packaging.Pictorial marking for handling of goods
GB/T 2828.1-2003 Sampling procedures for inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
YY 0607-2007 Medical electrical equipment—Part 2: Particular requirements for the safety of nerve and muscle stimulators
YY/T 0165-2007 Medical heating pad therapy equipment
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