new gb19082 test report qingdao weida biotechnology co.,ltd-译文 · 2020. 8. 4. · qingdao weida...
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
Test Report Report No.: Y2020022413
Client: Qingdao Weida Biotechnology Co., Ltd.
Manufacturer: Qingdao Weida Biotechnology Co., Ltd.
Sample name: disposable medical protective clothing (non-sterile)
Specification & model: one-piece type 185
Test type: registration test
National Medical Products Administration Jinan Quality Supervision and Inspection Center for
Medical Devices
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
Notices
I. The report is invalid without special seal for test report of the testing institution or official seal
of the testing unit.
II. The report shall not be copied without written approval of the testing institution.
III. The copied report is invalid without new special seal for test report of the testing institution or
official seal of the testing unit.
IV. The report is invalid without signature of the approver.
V. The report is invalid if altered.
VI. In case of objection against the test report, unless otherwise regulated, the objection shall be
put forward to our “Center” within fifteen days upon receiving the report.
VII. The report is responsible for the sample only.
Address: No. 15166, Century Avenue, New and High-tech Zone, Jinan City, Shandong Province
Telephone: 0531-82682920
Fax: 0531-82682936
Post code: 250101
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Initial Page of Test Report
Report No.: Y2020022413 Page 1/6
Sample name Disposable medical protective clothing (non-sterile) Sample No. Y2020022413
Sampling method Send sample
Trademark Figurative mark Specification &
model One-piece type 185
Client Qingdao Weida Biotechnology Co., Ltd.
Test type Registration test
Address of Client
No. 17, Weida Road, Guanzhuang Village, Yifengdian Town, Jimo District, Qingdao City, Shandong Province
Product No. / batch No.
WDFB/2001
Manufacturer Qingdao Weida Biotechnology Co., Ltd.
Sampling list No.
--
Tested unit Qingdao Weida Biotechnology Co., Ltd.
Date of manufacture
February 20, 2020
Sampling unit -- Sample size 23 pieces Sampling place -- Sample base --
Sampling date -- Test place Laboratory of our Center
Sample-receiving date
February 24, 2020 Test date February 24, 2020 ~ March 2, 2020
Test item Other items except sterility and residual ethylene oxide. Test basis Product technical requirements for Disposable Medical Protective Clothing
Test conclusion
All test items conformed to product technical requirements for Disposable Medical Protective Clothing.
(Special seal for test report) Special Seal for Testing of National Medical Products Administration Jinan
Quality Supervision and Inspection Center for Medical Devices (sealed) Date of issuance: March 9, 2020
Remark 1) “--” in the report means Not Applicable, and “/” in the report means Blank.
Approver: Title: Technical Director
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Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Test Report
Report No.: Y2020022413 Page 2/6
Test basis
Product technical requirements for
Disposable Medical Protective Clothing
Sample batch No. WDFB/2001
Specification & model One-piece type 185 Test date February 24, 2020 ~ March 2, 2020
Serial No. Test item
Technical requirement
clause
Technical requirement
Test results
Single conclusion
1
Microbiological indicators
Total number of bacterial colonies, CFU/g
2.10
≤200 0 Conformant
2 Coliform group Can’t be detected Not
detected Conformant
3 Pseudomonas aeruginosa Can’t be detected
Not detected Conformant
4 Staphylococcus aureus Can’t be detected
Not detected Conformant
5 Hemolytic streptococcus Can’t be detected
Not detected Conformant
6
Total number of fungal colonies, CFU/g
≤100 28 Conformant
Remark:
Reviewer: Tester:
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Test Report
Report No.: Y2020022413 Page 3/6
Test basis
Product technical requirements for
Disposable Medical Protective Clothing
Sample batch No. WDFB/2001
Specification & model One-piece type 185 Test date
February 24, 2020 ~ February 25, 2020
Serial No. Test item Technical
requirement clause
Technical requirement Test results
Single conclusion
1
Appearance
2.1.1
The protective clothing shall be
dry, clean and free of mildew, and the
surface shall be free of adhesion, cracks, holes or
other defects
Conform to requirement Conformant
2
2.1.2
Connection part of the protective clothing shall
apply processing methods such as
stitching, bonding or heat seal, etc.
Conform to requirement Conformant
3
The needle eyes of stitching shall be
of sealing treatment, and the needle pitch shall
be 8-14 needles/3cm, and
the stiches shall be even, flat and
straight, and free of skipping stiches
Conform to requirement;
(12-13) needles/cm
Conformant
4
The parts after bonding or heat seal and other
processing shall be flat, sealed and free of bubbles
Conform to requirement Conformant
5 2.1.3
For protective clothing with
zipper, the zipper can’t be exposed,
and the zipper head shall be
capable of
Conform to requirement Conformant
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self-locking
6
Structure
2.2.1
The protective clothing is of
one-piece structure, and
consists of hoodie and pant
Conform to requirement Conformant
7 2.2.2
The protective clothing shall have
reasonable structure, and
convenient to put on and take off, and the binding
parts shall be tight
Conform to requirement Conformant
8
2.2.3
The cuffs and leg openings apply
elastic convergence
Conform to requirement Conformant
9
Facial convergence of the hat and the waist part apply elastic
convergence, rope-pulling
convergence or agraffe
Elastic convergence Conformant
Remark:
Reviewer: Tester:
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Test Report
Report No.: Y2020022413 Page 4/6
Test basis Product technical requirements
for Disposable Medical Protective Clothing
Sample batch No. WDFB/2001
Specification & model One-piece type 185 Test date
February 24, 2020 ~ February 25, 2020
Serial No. Test item
Technical requirement
clause
Technical requirement Test results
Single conclusion
10
Model & Specification
Height
2.3
188cm ± 2cm (186-190) cm (189-190) cm Conformant
11 Chest circumference 145cm ± 2cm (143-147) cm (144-146) cm Conformant
12 Sleeve length 99cm ± 2cm (97-101) cm 97cm Conformant
13 Cuff 18cm ± 2cm (16-20) cm (16-17) cm Conformant
14 Leg opening 24cm ± 2cm (22-26) cm (24-25) cm Conformant
15
Liquid blocking function
Impermeability to water 2.4.1
Hydrostatic pressure in key parts of
the protective clothing shall
be no less than 1.67kPa (17cmH2O)
10KPa without water seepage Conformant
16 Water vapor transmission 2.4.2
Water vapor transmission
of the protective
clothing shall be no less
than 2500g/(m2•d)
(6340~6660)g/( m2•d) Conformant
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17 Resistance to
synthetic blood penetration
2.4.3
Resistance to synthetic
blood penetration
of the protective
clothing shall be no less than the Level 2
requirement in Table 2
Level 6 Conformant
18 Surface moisture resistance
2.4.4
Spray rating of outer side
of the protective
clothing shall be no less than the Level 3
requirement
Level 4 Conformant
19
Breaking force (dry state) 2.5
Breaking force of
materials for key parts of
the protective clothing shall
be no less than 45N
Horizontal: 69N Conformant
20 Longitudinal: 131N Conformant
21
Breaking elongation (dry state) 2.6
Breaking elongation of materials for key parts of
the protective clothing shall
be no less than 15%
Horizontal: 76% Conformant
22 Longitudinal: 57% Conformant
Remark:
Reviewer: Tester:
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Test Report
Report No.: Y2020022413 Page 5/6
Test basis Product technical requirements
for Disposable Medical Protective Clothing
Sample batch No. WDFB/2001
Specification & model One-piece type 185 Test date
February 24, 2020 ~ February 25, 2020
Serial No. Test item
Technical requirement
clause
Technical requirement Test results
Single conclusion
23
Filtration efficiency 2.7
Filtration efficiency of
key parts’ materials and joint place of the protective
clothing against non-oil
particles shall be no less than 70%
Key parts: 100% Conformant
24 Joint place: 100% Conformant
25 Anti-static property 2.8
Electric charge of the
protective clothing shall be no bigger
than 0.6μC/piece
0.4μC/piece Conformant
26
Static decay property 2.9
Static decay time of the
materials for the protective clothing shall
not exceed 0.5s
+5000V: 0.003s Conformant
27 -5000V: 0.003s Conformant
Remark:
Reviewer: Tester:
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Qingdao Weida Biotechnology Co., Ltd. Fraudulent use of the pictures are prohibited, and the offenders will be prosecuted!
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices
Test Report
Report No.: Y2020022413 Page 6/6
Picture and Description
Sample description
/
Specification & model or other descriptions
One-piece type 185
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Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
Pre-assessment Opinions on Technical Requirements for Medical
Devices
Test report No.: Y2020022413 Page 1/1
I. Completeness and applicability of the performance indicators in the product technical requirements; whether the test method is operable and repeatable, and whether it is matched with the test requirements.
No problems discovered with the test items.
II. If tested in accordance with the existing compulsory or recommended national standards and industry standards, the completeness of the compulsory national standards and industry standards applied, the suitability of the standards applied with the product, and the applicability of the clauses used.
No problems discovered with the test items.
III. If the test contents involve citation of relevant contents from Pharmacopoeia of the People’s Republic of China, the completeness, suitability and applicability of the citation.
No such contents with the test items.
IV. Other problems needing to be described:
None
V. Comprehensive assessment opinion:
□√ Upon pre-assessment, there is no opinion on supplementation and improvement of the product technical requirements.
□ Upon pre-assessment, the product technical requirements need to be further supplemented and improved in the following aspects:
Performance indicators;
Applicable national standards and industry standards;
Cited contents from Pharmacopoeia of the People’s Republic of China;
(Seal)
Special Seal for Testing of National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices (sealed)
March 9, 2020
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Y2020022413 March 9, 2020 Controlled Document Archived
Medical Disposable Protective Clothing
1. Product model / specification and its classification description
1.1 Product model / specification:
Medical disposable protective clothing (hereinafter referred to as “protective clothing”) has the model of: one-piece type, and the specification of: 168, 170, 175, 180, and 185.
1.2 Classification description
It is classified according to specification and size of the product.
1.3 Structural composition and raw materials
The medical disposable protective clothing is of one-piece structure, and mainly consists of hoodie and pant. The product is supplied in sterile or non-sterile form.
Raw materials of various parts: the hoodie and pant apply non-woven PE film fabrics, the sealing rubber strip applies double faced adhesive tape, the elastic convergence applies rubber band, the zipper applies nylon zipper and the mound layer applies EVA materials.
2. Performance indicators
2.1 Appearance
2.1.1 The protective clothing shall be dry, clean and free of mildew, and the surface shall be free of adhesion, cracks, holes or other defects.
2.1.2 Connection part of the protective clothing shall apply processing methods such as stitching, bonding or heat seal, etc. The needle eyes of stitching shall be of sealing treatment, and the needle pitch shall be 8-14 needles/3cm, and the stiches shall be even, flat and straight, and free of skipping stiches. The parts after bonding or heat seal and other processing shall be flat, sealed and free of bubbles
2.1.3 For protective clothing with zipper, the zipper can’t be exposed, and the zipper head shall be capable of self-locking.
2.2 Structure
2.2.1 The protective clothing consists of hoodie and pant, and is of one-piece structure, as shown in Figure 1.
2.2.2 The protective clothing shall have reasonable structure, and convenient to put on and take off, and the binding parts shall be tight.
2.2.3 The cuffs and leg openings apply elastic convergence, and the facial convergence of the hat and the waist part apply elastic convergence, rope-pulling convergence or agraffe.
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袖长 sleeve length 1/2袖口(不含松紧)1/2 sleeve opening (non-elastic) 1/4胸围 1/4 chest circumference 身长 height 1/2脚口(不含松紧)1/2 leg opening (non-elastic) 图 1 连体式结构防护服 Fig. 1 one-piece type protective clothing 2.3 Size specification
Specification of protective clothing shall meet the requirements in Table 1 below.
Size specification of disposable medical protective clothing Unit: cm
Name Height
Chest circumference
Sleeve length Sleeve
opening Leg opening
Size 165 169 125 86 18 24 170 173 130 90 18 24 175 176 135 93 18 24 180 181 140 96 18 24 185 188 145 99 18 24
Tolerance ±2 ±2 ±2 ±2 ±2
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2.4 Liquid blocking function
2.4.1 Impermeability to water
Hydrostatic pressure of key parts of protective clothing shall not be lower than 1.6kPa (17cmH2O).
2.4.2 Water vapor transmission
The amount of water vapor transmission of protective clothing material shall not be lower than 2500g/(m2*d).
2.4.3 Resistance to synthetic blood penetration
Resistance to synthetic blood penetration of protective clothing shall not be lower than the Rate 2 in Table 2.
Table 2 Rating of resistance to synthetic blood penetration
Rate Pressure value kPa
6 20 5 14 4 7 3 3.5 2 1.75 1 0a
* indicates that the pressure of the material is only that generated by the synthetic blood in the experimental tank. 2.4.4 Surface moisture resistance
Spray rating of outer surface of protective clothing shall not be lower than Rate 3.
2.5 Breaking strength
Breaking strength of key part of protective clothing shall not be less than 45N.
2.6 Breaking elongation
Breaking elongation of key part of protective clothing shall not be less than 15%.
2.7 Filtration efficiency
Filtration efficiency of key parts’ materials and joint place of the protective clothing against non-oil particles shall be no less than 70%
2.8 Anti-static property
Electric charge of the protective clothing shall be no bigger than 0.6μC/piece
2.9 Static decay property
Static decay time of the materials for the protective clothing shall not exceed 0.5s
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2.10 Microbiological indicator
Protective clothing shall meet the requirements of microbiological indicators in GB15979-2002. See Table 3 for details.
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Table 3 Microbiological indicators of protective clothing
Total number of bacterial
colonies CFU/g
Coliform Pseudomonas aeruginosa
Staphylococcus aureus
hemolytic streptococcus
Total number of fungal colonies CFU/g
≤200 ND ND ND ND ≤100 2.11 Sterility
Protective clothing marked “sterilized” or “sterile” on the package shall be sterile.
2.12 Ethylene oxide residue
Ethylene oxide residue on protective clothing sterilized with ethylene oxide shall not exceed 10ug/g.
3. Inspection method
3.1 Appearance
3.1.1 Visual inspection is adopted, and the results shall meet the requirements of 2.1.
3.1.2 Visual inspection is adopted, needle spacing is measured using a general measuring tool, and the results shall meet the requirements of 2.2.
3.1.3 Zippers of each sample of protective clothing shall be pulled up and down for 5 times, and the results shall meet the requirements of 2.1.
3.2 Structure
Visual inspection is adopted, and the results shall meet the requirements of 2.2.
3.3 Size specification
Three sample of protective clothing of each size specification shall be tested using general measuring tool, and their specifications shall meet the requirements of 2.3.
3.4 Liquid blocking function
3.4.1 Impermeability to water
Samples are taken from key parts of protective clothing and given hydrostatic test stipulated in GB/T4744-1997, and the results shall meet the requirements of 2.4.1.
3.4.2 Water vapor transmission
Materials of protective clothing shall be tested according to Method A: Moisture Adsorption stipulated in GB/T12704-1991, and the results shall meet the requirements of 2.4.2.
3.4.3 Resistance to synthetic blood penetration
Materials of protective clothing shall be tested for resistance to synthetic blood penetration, and the results shall meet the requirements of 2.4.3.
3.4.4 Surface moisture resistance
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Outer materials of protective clothing shall be given spray test stipulated in GB/T4745-1997, and the results shall meet the requirements of 2.4.4.
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3.5 Breaking strength
Key parts of protective clothing shall be tested according to the Strip Method stipulated in GB/T3923. 1-1997, and the results shall meet the requirements of 2.5.
3.6 Breaking elongation
Key parts of protective clothing shall be tested according to the Strip Method stipulated in GB/T3923. 1-1997, and the results shall meet the requirements of 2.6.
3.7 Filtration efficiency
At least 3 samples of protective clothing shall be tested, and the results shall meet the requirements of 2.7.
Sodium chloride aerosols or similar solid aerosols [count median diameter (CMD): 0.075μm±0.020μm; geometric standard deviation (GSD) of particle distribution: ≤1.86; concentration: ≤200mg/m3] shall be used in an environment with a relative humidity of 30%±10% and a temperature of 25℃±5℃. Airflow rate is set as 15L/min±2L/min, and the cross-sectional area of the airflow is 100cm2.
3.8 Anti-static property
Anti-static property shall be tested according to the method stipulated in 7.2 in GB/T 12703-1991, and the results shall meet the requirements of 2.8.
3.9 Static decay property
3.9.1 Test environment
Before the test, the samples shall be placed in an environment with a relative humidity of 50%±3% and a temperature of 23℃±1℃ for 24h. The samples shall also be tested in such an environment.
3.9.2 Sampling
A sample of 89mm×(152±6) mm is taken from each key part of protective clothing. Latex or cotton gloves are required during the sampling to prevent contamination of the sample surface.
3.9.3 Test
According to the method in IST40.2 (01), five test samples shall be installed on the static decay measuring instrument which can generate at least a voltage of ±5000V, then a voltage of 5000V is applied to the material, and the charge decay time is measured. The decay time of all the test samples shall meet the requirements of 2.9.
3.10 Microbiological indicator
The samples of protective clothing shall be tested according to the method stipulated in Appendix B in GB15979-2002, and the results shall meet the requirements of 2.10.
3.11 Sterility
Three sets of samples are taken and tested according to the direct inoculation method in
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Pharmacopoeia of the People’s Republic of China (2015) Volume 4: Sterility Tests, and the results shall meet the requirements of 2.11.
3.12 Ethylene oxide residue
Ethylene oxide residue shall be tested according to the method stipulated in 5.13 in GB 19082-2009, and the results shall meet the requirements of 2.12.
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