SN/T 1672.7-2013 English PDF (SNT1672.7-2013)

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SN/T 1672.7-2013: Rules for the inspection of medical equipment for import and export. Part 7: Medical endoscope
SN/T 1672.7-2013
SN
ENTRY-EXIT INSPECTION AND QUARANTINE INDUSTRY
Replacing SN/T 1095-2002
Rules for the inspection of the medical equipment for import
and export - Part 7.Medical endoscope
ISSUED ON. NOVEMBER 06, 2013
IMPLEMENTED ON. JUNE 01, 2014
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 7
4 General requirements... 8
5 Inspection... 8
6 Qualified batch judgement and validity period... 13
7 Treatment of unqualified batches... 13
Foreword
SN/T 1672 "Rules for the inspection of the medical equipment for import and export"
is divided into 8 parts.
- Part 1.General requirements;
- Part 2.General spiral computed tomography scanner;
- Part 3.Transcranial Doppler blood flow analyzer;
- Part 4.B mode ultrasonic diagnostic equipment;
- Part 5.Medical diagnostic X-ray equipment;
- Part 6.Magnetic resonance imaging equipment for medical diagnosis;
- Part 7.Medical endoscope;
- Part 8.Ultrasonic diagnostic and physiotherapy equipment.
This Part is Part 7 of SN/T 1672.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces SN/T 1095-2002 "For the inspection of imported medical endoscope
performance".
Compared with SN/T 1095-2002, the main technical changes of this Part are as follows.
- ADD the content of Chapter 4 General requirements;
- CANCEL the concept of handover inspection in Chapter 5 Inspection in the original
Rules; CHANGE the inspection mode to type test mode, conformity verification
mode, sampling inspection mode;
- MODIFY the inspection content, inspection methods, technical requirements in
Chapter 5 Inspection in the original Rules;
- MODIFY the single sampling scheme in the sampling inspection of the original
Rules 5.4 to special inspection level S-1.
Please note that some contents of this document may involve patents. The issuing
agency of this document does not assume the responsibility for identifying these patents.
This Part was proposed by AND shall be under the jurisdiction of the National
Certification and Accreditation Administration.
Rules for the inspection of the medical equipment for import
and export - Part 7.Medical endoscope
1 Scope
This Part of SN/T 1672 stipulates the sampling, inspection, determination of inspection
results for imported and exported medical endoscopes.
This Part applies to the import and export inspection of imported and exported medical
endoscopes.
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1.Sampling
schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB 9706.1-2007 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 11244 General requirements for the medical endoscope and endoscope
accessories
YY 0068.1 Medical Endoscopes - Rigid Endoscope - Part 1.Optical properties and
test methods
YY 0068.2-2008 Medical endoscopes - Rigid endoscope - Part 2.Mechanical
properties and test methods
YY 0505 Medical electrical equipment - Part 1-2.General requirements for safety -
Collateral standard. Electromagnetic compatibility - Requirements and tests (IEC
60601-1-2.2001, IDT)
YY 1028-2008 Upper gastro intestinal fiberscope
4 General requirements
4.1 Safety requirements
The safety requirements of medical endoscopes shall comply with the provisions of GB
9706.1-2007, GB 9706.19-2000, GB 11244.The differences in the countries (regions)
of use shall be considered when applicable.
4.2 Electromagnetic compatibility requirements
The electromagnetic compatibility requirements of medical endoscopes shall meet the
provisions of YY 0505; the differences in the countries (regions) of use shall be
considered when applicable.
4.3 Other requirements
When applicable, it shall also comply with the relevant technical requirements of the
countries (regions) of use for environmental protection, energy efficiency, performance,
etc. of medical endoscopes.
5 Inspection
5.1 Selection of inspection and supervision mode
The inspection of imported and exported medical endoscopes can be carried out
according to relevant national provisions, selecting the mode of type test, mode of
sampling inspection, mode of compliance verification in accordance with the specific
circumstances.
5.2 Inspection method
The inspection methods under different inspection and supervision modes are.
a) Mode of type test. Type test and unpacking inspection;
b) Mode of sampling inspection. Batch sampling or batch-by-batch sampling
inspection;
c) Mode of compliance verification. Certificate inspection and unpacking inspection.
5.3 Type test
5.3.1 Situations to be carried out
Type test shall be carried out in any of the following situations.
a) When the product is exported for the first time;
b) When production is resumed after suspension for more than half a year;
c) When changes in design, process or materials may affect its performance;
d) When the supervisory department proposes to conduct tests.
5.3.2 Sampling
A certain number of prototypes are randomly selected from the type-finalized products
in accordance with the relevant standards.
5.3.3 Inspection content
5.3.3.1 Safety testing
All applicable items shall be tested in accordance with GB 9706.1-2007, GB 9706.19-
2000, GB 11244.
5.3.3.2 Electromagnetic compatibility inspection
All applicable items shall be tested in accordance with YY 0505.
5.3.3.3 Performance testing
All applicable items shall be tested in accordance with GB 11244, YY 0068.1, YY
0068.2-2008, YY 1028-2008.
5.3.4 Result determination
If all type test inspection items are qualified, the type test is judged to be qualified;
otherwise, it is unqualified.
5.3.5 Disposal of unqualified items
If the type test is judged to be unqualified, it is allowed to be resubmitted for inspection
once after technical processing, provided that it is permitted by laws and regulations.
5.4 Sampling inspection
5.4.1 Sampling
According to the batch size of the inspection batch, select the corresponding sample
batch for sampling according to the special inspection level S-1 of the normal inspection
single sampling plan of GB/T 2828.1 (see Table 1).
If the sampling inspection is judged to be unqualified, it is allowed to be resubmitted
for inspection once after technical treatment under the premise of laws and regulations.
5.5 Compliance verification
5.5.1 Contents of compliance verification
When applicable, according to the mandatory requirements of the technical
specifications of the country (region) of use, the inspection certificate and voucher and
the goods shall be consistent.
5.5.2 Result judgment
If all verification contents are consistent, the compliance verification is judged to be
qualified; otherwise, it is unqualified.
5.5.3 Treatment of unqualified items...