This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules, signs, packaging, transportation, and storage of balloon-type external counterpulsation devices. This standard is applicable to various types of balloon-type external counterpulsation devices (hereinafter referred to as counterpulsation devices). The counterpulsation device is used by medical units for clinical treatment of ischemic diseases of heart, brain, kidney and other organs, and has functions of rehabilitation and health care.
GB 10035-2006 Referenced Document
GB 5013.1-1997 Rubber insulated cables of rated voltages up to and including 450/750V. Part 1: General requirements
GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
GB 9969.1 General principles for preparation of instructions for use of industrial products
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods*, 2008-04-01 Update
GB 10035-2006 history
2017GB 10035-2017 Air-bag type sequential external counter-pulsation device
2006GB 10035-2006 Air-bag type sequential external counter-pulsation device
1994GB 10035-1994 The alr-bag type sequential external counter-pulsation device