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SN/T 1430.1-2004Imported medical equipment for the inspection of ultrasonic medical diagnostic and treatment equipment (English PDF)

进口医疗器械检验规程 医用超声诊断和治疗设备

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China

Level / Type

National · Recommended

Issue date

June 1, 2004

Implementation date

December 1, 2004

Scope

SN/T 1430.1-2004 is the English-translated version of 进口医疗器械检验规程 医用超声诊断和治疗设备.

SN/T 1430.1-2004 — 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.

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Document preview — SN/T 1430.1-2004

National Standard of the People's Republic of China

ICS
11.040
Classification
C 41

Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Inspection
  • 4.1 Inspection method
  • 4.2 Sampling
  • 4.3 Inspection method

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.

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 4 pages — is available in the English PDF.

Referenced standards

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