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SN/T 0869-2017Determination of ascorbic acid in beverage for export (English PDF)

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Issued by

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

Level / Type

National · Recommended

Issue date

November 6, 2013

Implementation date

June 1, 2014

Scope

SN/T 0869-2017 (Determination of ascorbic acid in beverage for export) is available as an English-translated PDF.

SN/T 0869-2017 — 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.

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Document preview — SN/T 0869-2017

National Standard of the People's Republic of China

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

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

If the compliance verification is judged to be unqualified, it is allowed to be resubmitted

for verification after technical treatment under the premise of laws and regulations.

5.6 Unpacking inspection

5.6.1 Sampling

According to the batch size of the inspection batch, select the corresponding sample

size 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).

5.6.2 Inspection content

The items, content, method requirements of the unpacking inspection are detailed in

Table 2.

5.6.3 Result judgement

If all inspection items are qualified, the unpacking inspection is judged to be qualified;

otherwise, it is unqualified.

5.6.4 Treatment of unqualified items

If the unpacking inspection is judged to be unqualified, it is allowed to be resubmitted

for inspection once after technical treatment, provided that it is permitted by laws and

regulations.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.

Referenced standards

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