New GB19082 Test report Qingdao Weida Biotechnology Co.,Ltd-译文 · 2020. 8. 4. · Qingdao Weida...

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



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



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




Test Report


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


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


5 Hemolytic streptococcus Can’t be detected


6

Total number of fungal colonies, CFU/g

≤100 28 Conformant

Remark:

Reviewer: Tester:




Test Report


Test basis

Product technical requirements for

Disposable Medical Protective Clothing


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.


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


5 2.1.3

For protective clothing with

zipper, the zipper can’t be exposed,

and the zipper head shall be

capable of




self-locking

6

Structure

2.2.1

The protective clothing is of

one-piece structure, and

consists of hoodie and pant


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


8

2.2.3

The cuffs and leg openings apply

elastic convergence


9

Facial convergence of the hat and the waist part apply elastic

convergence, rope-pulling

convergence or agraffe

Elastic convergence Conformant

Remark:

Reviewer: Tester:




Test Report


Test basis Product technical requirements

for Disposable Medical Protective Clothing






clause


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



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


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


be no less than 15%

Horizontal: 76% Conformant

22 Longitudinal: 57% Conformant

Remark:

Reviewer: Tester:




Test Report


Test basis Product technical requirements

for Disposable Medical Protective Clothing






clause


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:




Test Report


Picture and Description

Sample description

/

Specification & model or other descriptions

One-piece type 185



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)


March 9, 2020



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.



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



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



2.10 Microbiological indicator

Protective clothing shall meet the requirements of microbiological indicators in GB15979-2002. See Table 3 for details.



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



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.



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



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.

New GB19082 Test report Qingdao Weida Biotechnology Co.,Ltd-译文 · 2020. 8. 4. · Qingdao Weida...

Documents

Transcript of New GB19082 Test report Qingdao Weida Biotechnology Co.,Ltd-译文 · 2020. 8. 4. · Qingdao Weida...