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SN/T 1430.1-2004: Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment
Status: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| SN/T 1430.1-2004 | English | 199 |
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Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment
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SN/T 1430.1-2004
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PDF similar to SN/T 1430.1-2004
Standard similar to SN/T 1430.1-2004 YY/T 1676 YY/T 1671 YY/T 1601 SN/T 1672.8 Basic data | Standard ID | SN/T 1430.1-2004 (SN/T1430.1-2004) | | Description (Translated English) | Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040 | | Word Count Estimation | 5,585 | | Date of Issue | 2004-06-01 | | Date of Implementation | 2004-12-01 | | Quoted Standard | GB/T 2828.1; GB 9706.1-1995 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China | | Summary | This standard specifies the import of medical ultrasonic diagnostic and therapeutic equipment, sampling, testing and test results to determine. This standard applies to imports of medical diagnostic and therapeutic ultrasound equipment inspection. | SN/T 1430.1-2004: Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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
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