SN/T 1095-2002 English PDF (SNT1095-2002)

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