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SN/T 1672.4-2005: Rules for the inspection of medical equipment for import and export. Part 4: B mode ultrasonic diagnostic equipment
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SN/T 1672.4-2005: Rules for the inspection of medical equipment for import and export. Part 4: B mode ultrasonic diagnostic equipment

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Rules for the inspection of medical equipment for import and export.Part 4. B mode ultrasonic diagnostic equipment People's Republic of China Entry-Exit Inspection and Quarantine Industry Standard Import and export medical equipment inspection procedures Part 4. B-mode ultrasound diagnostic equipment Released on September 15,.2005 2006-05-01 implementation People's Republic The General Administration of Quality Supervision, Inspection and Quarantine issued

Foreword

SN/T 1672 "Import and Export Medical Equipment Inspection Regulations" is divided into several parts, and its expected structure is. --- Part 1. General requirements; --- Part 2. Whole body spiral CT scanner; --- Part 3. Transcranial Doppler blood analyzer; --- Part 4. B-mode ultrasound diagnostic equipment. This part is the fourth part of SN/T 1672. This part is proposed and managed by the National Certification and Accreditation Administration. This section drafted by. Shenzhen Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China. The main drafters of this section. Zhong Liqin, Liao Wei, Zhang Hanzhong, Xu Qin, Zeng Fanli. This section is the first published industry standard for entry-exit inspection and quarantine. Import and export medical equipment inspection procedures Part 4. B-mode ultrasound diagnostic equipment

1 Scope

This part of SN/T 1672 specifies the sampling, inspection and qualification of the B-type ultrasonic diagnostic equipment for import and export. This section applies to the import and export inspection of B-type ultrasonic diagnostic equipment powered by the grid power supply or power supply equipment.

2 Normative references

The provisions in the following documents become the provisions of this part by reference to this part of SN/T 1672. Quotations with dated , all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouragement is achieved under this section The parties to the agreement study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this section. GB 4205 Controls the standard movement direction of the operating parts of electrical equipment GB 9706.1-1995 General safety requirements for medical electrical equipment GB 9706.9-1997 Safety requirements for ultrasonic diagnostic and monitoring equipment GB 16846-1997 Ultrasonic diagnostic equipment sound output announcement requirements Basic requirements for the preparation of SN/T 0002 import and export electromechanical commodity inspection procedures IEC 60601-1-2 Medical electrical equipment - Part 1-2. General safety requirements Parallel standard Electromagnetic compatibility requirements and testing (MedicalElectricalEquipment-Part 1-2. GeneralRequirementsforSafety-ColateralStandard.Elec- tromagneticCompatibility-RequirementsandTestsSecondEdition)

3 Terms and definitions

The terms and definitions established by SN/T 0002 and the following terms and definitions apply to this part of SN/T 1672. 3.1 The standard style of things or activities. 3.2 Standard style based on the elements of the Commodity Inspection Act and related international general conformity assessment procedures or their combinations. 3.3 According to the mandatory requirements of the national technical specifications, the B-type ultrasonic diagnostic equipment for import and export shall be inspected and inspected one by one according to the on-site inspection regulations. Conformity assessment activities. 3.4 According to the mandatory requirements of the national technical specifications, the type test shall be carried out according to the prescribed period, and the products shall be subjected to batch inspection according to the on-site inspection regulations. Inspection and implementation of the conformity assessment activities of the company's quality management system. ...