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SN/T 1430.1-2004: Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
SN/T 1430.1-2004	English	199	Add to Cart	2 days [Need to translate]	Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment

SN/T 1430.1-2004: Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment

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Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment People's Republic of China Entry-Exit Inspection and Quarantine Industry Standard Imported medical device inspection procedures Medical ultrasound diagnosis and treatment equipment Released on June.2004 Implementation of.2004-12-01 People's Republic The General Administration of Quality Supervision, Inspection and Quarantine issued

Foreword

This standard is proposed and managed by the National Certification and Accreditation Administration. This standard was drafted. Zhejiang Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China. The main drafters of this standard. Li Bingqiang, Tang Weiping, Niu Wei, Zhang Junxin. This standard is the industry standard for inspection and quarantine issued for the first time. Imported medical device inspection procedures Medical ultrasound diagnosis and treatment equipment

1 Scope

This standard specifies the sampling, inspection and determination of the results of imported medical ultrasound diagnostic and therapeutic equipment. This standard applies to the inspection of imported medical ultrasound diagnostic and therapeutic equipment.

2 Normative references

The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard. GB/T 2828.1. Sampling and sampling procedures - Part 1 . Batch-to-batch sampling plan searched by the acceptance quality limit (AQL) GB 9706.1-1995 Medical electrical equipment - Part 1. General requirements for safety

3 Terms and definitions

The following terms and definitions apply to this standard. The same batch of imported medical ultrasonic diagnostic and therapeutic equipment of the same specification and model under the same contract is called an inspection batch, referred to as the batch.

4 inspection

4.1 Inspection method The settlement inspection is divided into unpacking inspection and machine performance and safety inspection, and each batch must be inspected. 4.2 Sampling 4.2.1 Sampling conditions The batch submitted for sampling shall be inspected by the manufacturer and a valid quality inspection report shall be provided. 4.2.2 Sampling plan 4.2.2.1 Sampling plan and inspection level The settlement inspection adopts GB/T 2828.1 normal inspection once sampling plan, and the inspection level is special inspection level S-1. 4.2.2.2 Receive quality limit AQL value Consignment inspection non-conforming products are classified into Class A, Class B and Class C. --- Class A non-conforming product. not allowed; --- Class B non-conforming product. AQL=1.5; ---C non-conforming product. AQL=4.0. 4.2.3 Sampling method Samples were randomly drawn from the batch. 4.3 Inspection method 4.3.1 Unpacking inspection The unpacking inspection items are packaging, appearance, marking, random documents and specifications. The quality requirements, inspection methods and unqualified classification are shown in Table 1. 4.3.2 Machine performance and safety inspection Machine performance and safety inspection items are protective grounding and functional grounding, continuous leakage current and patient auxiliary current, dielectric strength and performance ...