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SN/T 1095-2002 PDF English

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SN/T 1095-2002: For the inspection of imported medical endoscope performance
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SN/T 1095-2002: For the inspection of imported medical endoscope performance

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SN ENTRY-EXIT INSPECTION AND QUARANTINE INDUSTRY Rules for the inspection of the performance of medical endoscopes for import Issued on: MARCH 15, 2002 Implemented on: SEPTEMBER 01, 2002 Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Definitions... 4 4 Sampling... 5 5 Inspection... 5 Rules for the inspection of the performance of medical endoscopes for import

1 Scope

This standard specifies the sampling, performance inspection and judgment of inspection results of imported medical endoscopes. This standard applies to the performance inspection of imported medical endoscopes, including soft endoscopes (upper gastrointestinal endoscopes, bronchoscopes, colonoscopes, nephroscopes, vascular and cardiac endoscopes) and rigid endoscopes (cystoscopes, laparoscopes, arthroscopes, thoracoscopes, hysteroscopes, encephaloscopes, otoscopes).

2 Normative references

The provisions in following documents become the provisions of this Standard through reference in this Standard. The versions indicated at the time of publication of this standard are valid. All standards are subjected to revision, AND parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. GB/T 2828-1987 Sampling procedures and tables for lot-by-lot inspection by attributes (Apply to inspection of successive lots or batches) GB 9706.1-1995 Medical electrical equipment - Part 1.General requirements for safety GB 9706.19-2000 Medical electrical equipment - Part 2.Particular requirements for the safety of endoscopic equipment GB 10036-1988 Upper gastro intestinal fiberscope GB 11244-1989 General specifications for medical fiber endoscope YY 0068-1992 General technical requirements for endoscope rigid tube - Definitions

3 Definitions

This standard adopts the following definitions. 3.1 Inspection batch The same batch of imported endoscopes with the same specifications and models is called an inspection batch, referred to as batch. 3.2 Medical endoscope A medical instrument with observation purpose, with or without a lens, inserted into the natural or surgically opened channels of the human body for inspection, diagnosis or treatment. 3.3 Rigid endoscope The insertion part of the endoscope cannot be bent to enter the natural or surgically opened channels of the human body. 3.4 Soft endoscope The insertion part of the endoscope can be bent to enter along the natural or surgically opened channels of the human body.

4 Sampling

4.1 Sampling conditions The inspection batch submitted for sampling must be inspected and qualified by the manufacturer; a valid quality inspection report must be provided. 4.2 Sampling scheme Sampling is carried out by batch, using the normal one-time sampling plan of GB/T 2828 and the inspection level is I.

5 Inspection

5.1 The performance and safety performance inspection of the whole machine is the handover inspection; each batch of handover inspection is a mandatory inspection item. 5.2 Inspection item The inspection includes packaging, whole machine performance, safety performance inspection, review of random documents. 5.3 Inspection requirements 5.3.1 The padding, fixing method, sealing, shockproof, moisture-proof measures taken ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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