Translated English of Chinese Standard: YY0903-2013 www.chinesestandard.net Sales@ChineseStandard.net PHARMACEUTICAL STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS 11.040.60 C 42 Electroencephalographic Biofeedback Equipment 脑电生物反馈仪 Issued on: October 21, 2013 Implemented on: October 1, 2014 Issued by: China Food and Drug Administration www.chinesestandard.net Page 1 of 16
Table of Contents Foreword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 5 4 Classification and Composition... 6 5 Requirements... 6 6 Test Method... 8 7 Inspection Rules... 13 8 Marking and Instruction Manual... 14 9 Packaging, transportation and storage... 16 www.chinesestandard.net Page 2 of 16
Foreword If the materials or structures of the equipment or components are different from those specified in this Standard, they should be approved only if it can be certified that they meet equivalent specifications. Please be noted that some content of this document may involve patents. The issuer of this document is not responsible for identifying such patents. This Standard was drafted according to the rules given in GB/T 1.1-2009. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of the Technical Subcommittee of Physical Therapy Equipment of the National Technical Committee for Standardization of Medical Electrical Equipment (SAC/TC 10/SC 4). The main drafting organization of this Standard: China Food and Drug Administration Tianjin Medical Devices Quality Supervision and Testing Center and Guangzhou Rainjet Medical Devices Co., Ltd. The main drafters of this Standard: Liu Hui, Sun Huili, Ji Caiyan, Hu Zhiwei and Yang Jie. www.chinesestandard.net Page 3 of 16
Electroencephalographic Biofeedback Equipment 1 Scope This Standard specifies the definitions, classification and composition, requirements, test methods, inspection rules, marking, packaging, packaging and transportation. This Standard applies to the electroencephalographic biofeedback equipment. 2 Normative References The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard. GB/T 191 Packaging Pictorial Marking for Handling of Goods GB 9706.1-2007 Medical Electrical Equipment Part 1: General Requirements for Safety GB 9706.15 Medical Electrical Equipment Part 1: General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Equipment GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Guidance on Selection of Tests GB/T 16886.5-2003 Biological Evaluation of Medical Devices Part 5: Test for in Vitro Cytotoxicity GB/T 16886.10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Delayed-type Hypersensitivity YY/T 0466.1 Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling and Information to Be Supplied Part 1: General Requirements YY 0505 Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility Requirements and Tests YY/T 0708 Medical Electrical Equipment Part 1-4: General Requirements for Safety Collateral Standard: Programmable Electrical Medical Systems www.chinesestandard.net Page 4 of 16
Depending on the frequency of the input signal, the manufacturer's specified high-pass cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at least 3 db. 5.2.7 Low-pass filter Depending on the frequency of the input signal, the manufacturer's specified low-pass cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at least 3 db. 5.2.8 Notch filter There shall be a 50Hz notch filter, and the amplitude value after attenuation does not be greater than 5μV (peak-to-valley value). 5.2.9 Time interval The error does not exceed ±5%. 5.2.10 Input impedance Not less than 5 MΩ. 5.2.11 Biocompatibility of EEG Electrodes The equipment parts and accessories which are expected to come in contact with the skin of the patient shall be evaluated and documented in accordance with the guidelines and principles given in GB/T 16886.1. 5.3 Requirements for the audio-visual stimulation part The manufacturer shall develop the appropriate technical requirements in accordance with the working principle of the audio-visual stimulation part. 5.4 Requirements for the feedback The manufacturer shall develop the appropriate technical requirements for the feedback triggering conditions and triggering forms in accordance with the feedback principle of the electroencephalographic biofeedback equipment. 5.5 Requirements for the software 5.5.1 The manufacturer shall develop the appropriate technical requirements in accordance with the functions of the electroencephalographic biofeedback equipment. 5.5.2 They shall meet the requirements of YY 0708. 5.6 Appearance The surface of the electroencephalographic biofeedback equipment shall be smooth www.chinesestandard.net Page 7 of 16
The test shall be conducted in accordance with the method specified by the manufacturer and shall meet the requirements of 5.3. 6.4 Requirements for the feedback The test shall be conducted in accordance with the method specified by the manufacturer and shall meet the requirements of 5.4. 6.5 Requirements for the software 6.5.1 The test shall be conducted in accordance with the method specified by the manufacturer and shall meet the requirements of 5.5.1. 6.5.2 The test shall be conducted in accordance with the method specified in YY 0708 and shall meet the requirements of 5.5.2. 6.6 Appearance Use eyes to observe the appearance and use hands to feel the surface. The results shall meet the requirements of 5.7. 6.7 Safety test The test shall be conducted in accordance with the method specified in GB 9706.1-2007 and shall meet the requirements of 5.7. 6.8 Electromagnetic compatibility test The test shall be conducted in accordance with the method specified in YY 0505 and shall meet the requirements of 5.8. 6.9 Environmental test The test shall be conducted in accordance with the method specified in GB/T 14710 and shall meet the requirements of 5.9. 7 Inspection Rules 7.1 Categories of inspection The quality inspection of the equipment can be divided into exit-factory inspection and type inspection. 7.2 Exit-factory inspection 7.2.1 The equipment to be delivered shall be inspected by the quality inspection department of the manufacturer piece by piece before it is delivered to the customer. Refer to Table 1 for the inspection items. www.chinesestandard.net Page 13 of 16
repair and safety precautions. 9 Packaging, transportation and storage 9.1 Packaging 9.1.1 The equipment shall be packed separately; the outer packing shall prevent the product from natural damages; and the packing materials shall be as specified in the purchase order. 9.1.2 The equipment shall be provided with the measures in the packing case such as rainproof, dampproof and soft padding. 9.1.3 The equipment shall be fixed securely in the packing case so as to prevent loosening or scratches during transportation. 9.1.4 The equipment can be transported in nude packing in accordance with the purchase contract; in case of nude packing, protective measures shall be taken during the transportation process; and the specific requirements shall be as specified by the purchase contract. 9.1.5 The equipment shall be accompanied by the following documents: a) a product inspection qualification certificate; b) a product instruction manual; d) a packing list; and d) a product service card. 9.2 Transportation The requirements for transportation shall be as specified by the purchase contract. 9.3 Storage The equipment shall be stored in a well-ventilated room, at the temperature -40 C ~ 50 C and the relative humidity not exceeding 90%, where there is no corrosive gas. END www.chinesestandard.net Page 16 of 16