File No.

AG-TCF-1-04/1
Technical File Rev. No. B
04. Product's manufacturing Rev. Date 2022.2.8

process Page 1

1.1 Product's manufacturing process

1.1.1 Suture needle's manufacturing process
Check steel wire(★) → pull straight and cutting → sharpened → polishing →cutting
→drill → Pressure into flat shape →pressed into a triangle →bend →quenching and
tempering (★)→grinding→ testing →packing(in cleaningroom) →storage
1.1.2 Needle with thread assembly

Selective suture needles and sutures (in cleaningroom)→Thread a needle pressing

line(★) (in cleaningroom) →Test(in cleaningroom) → Wrap the sutures around the
cardboard and install the foil bag(in cleaningroom)→ Seal(★) (in cleaningroom)→
loaded box(in cleaningroom) → encasement → Test →sterilization( ★ ) → testing →
storage
1.2 Key process description
1.2.1 Suture needle’s raw material：choose YB/T5219 medical suture needle steel
wire stated 3Cr13 or 4Cr13 steel wire，and provided quality guarantee.
1.2.2 Suture needle’s heating treatment(quenching，tempering): Control of
suture needle hardness, toughness, flexibility, ensuring suture needle is continuous in
use.
1.2.3 Thread a needle pressing line: It is the important process in manufacturing
process of Suture needle with thread. Needle and thread connection is not strong, when
stitch up the wound, the needle and thread are separation ，surgery would be delayed.
Pressure-line pre-prepared:
(1) Handling the head end of the suture in order to facilitate the insertion end of a
thread within the pinhole.
(2)Choose splint correctly, adjust the interval between splint，made the end of the hole
where is sufficient deformation ,in order to press suture firmly.
1.2.4 Needle and thread connection strength of test：
(1) After pressuring line, immediate the connection strength test, at any time to adjust
and check the working status of the pinning machine and splint;
(2) To sample during the pressuring line process;
(3) To test after the pressuring line for each kind of specification.
1.2.5 Sealing packaging bag:
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04. Product's manufacturing Rev. Date 2022.2.8

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After bagging the needle and thread, to seal when setting the seal parameters
according to the characteristics of packaging materials.
1.2.7 Sterilization:
Sterilization method，sterilize adopting RS method, RS method on sterilization by
Zhangjiagang Municipal CNNC Huakang Radiation CO., Ltd., sterilization should be to
6
achieve SAL＝ 10 .
RS methods on sterilization see CE technical documents CE-06 1section.
1.3 Control of the production environment
Pressuring lines, packaging, sealing and etc. are processed in 100,000 clean
workshop where accord with GMP requirements.
Sterile product quality assurance system as shown
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04. Product's manufacturing Rev. Date 2022.2.8

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raw material Check out 1.Straightening 2.sharpen 3.cutting 4.punching

（steel wire cutting
）

6.flattening 7.Bend 10.Quenching 11.grinding 12.washing

Triangle needle
tempering
(key control points)
5.washing
8.Press the 9.Grind
Round needle triangle triangle
Check out Check out

15. Needle and suture

connection(key control 18.Check out 19.Winding 20.inner
13.drying 14.Check out points)
21.¤sealing
packaging

16.sutures 17.Check out

Check out

22.Outside the 23.Box/ 24 25. Put in

bags
carton ¤ sterilization storage

explain：1. Each working procedure between process inspection.

2. The sterilization is the outsourcing processing; Process 15, 18-22 is the purification workshop production.
3. The sealing and sterilization process marked "¤" is a special procedure.
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04. Product's manufacturing Rev. Date 2022.2.8

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Harmonized standards
No. Reference Title
01 EN ISO Medical devices - Quality management systems - Requirements for
13485：2016 regulatory purposes
02 EN ISO Medical devices-Application of Risk Management to Medical Devices
14971:2019
03 ISO14155-1： Clinical investigation of medical devices for human subjects - Part 1:
2011 General requirements
04 EN ISO Medical devices-Symbols to be used with medical device labels,labeling and
15223-1:2021 information to be supplied
05 EN 1041:2008 Information Supplied by the Manufacturer with Medical Devices
06 EN ISO10993- Biological Evaluation of Medical Devices - Part 1: Evaluation and
1:2020 Testing
07 EN ISO10993- Biological Evaluation of Medical Devices - Part 3:Test for
3:2014 genotoxicity,carcinogenicity and reproductive toxicity
08 EN ISO10993- Biological Evaluation of Medical Devices - Part 4:Selection of tests for
4:2017 interactions with blood
09 EN ISO10993- Biological evaluation of medical devices - Part 5: Tests for in vitro
5:2009 cytotoxicity
10 ENISO10993 Biological evaluation of medical devices - Part 6:Test for local effects
-6:2016 after implantation
11 EN ISO10993- Biological evaluation of medical devices - Part 11:Test for systemic
11:2018 toxicity
Sterilization of health careproducts — Radiation
12 EN 11137- Part 1: Requirements for development,validation and routine control of
1:2015 a
sterilization process for medical devices
13 EN 11137- Sterilization of health careproducts — Radiation
1:2015 Part 2: Establishing the sterilization dose
Packaging for terminally sterilized medical devices - Part 1:
14 EN ISO Requirements for materials, sterile barrier systems and packaging
11607-1:2020 systems

EN ISO
15 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation
requirements for forming, sealing and assembly processes
EN Cleanrooms and associated controlled environments - Part 1:
16 ISO14644- Classification of air cleanliness by particle concentration (ISO
1:2015 14644-1:2015)
Cleanrooms and associated controlled environments - Part 2:
EN Monitoring to provide evidence of cleanroom performance
17
ISO14644- related to air cleanliness by particle concentration (ISO 14644-
2:2015 2:2015)
EN
18 ISO14644- Cleanrooms and associated controlled environments - Part 3:
3:2019 Test methods (ISO 14644-3:2005)
EN Cleanrooms and associated controlled environments - Part 4:
19
ISO14644- Design, construction and start-up (ISO 14644-4:2001)
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4:2001
EN
20 ISO14644- Cleanrooms and associated controlled environments - Part 5:
5:2005 Operations (ISO 14644-5:2004)
EN Cleanrooms and associated controlled environments - Part 7:
21 ISO14644- Separative devices (clean air hoods, gloveboxes, isolators and
7:2001 mini-environments) (ISO 14644-7:2004)
EN Cleanrooms and associated controlled environments - Part 8:
22 ISO14644- Classification of air cleanliness by chemical concentration (ACC)
8:2013 (ISO 14644-8:2013)
EN Cleanrooms and associated controlled environments -
23 ISO14698- Biocontamination control - Part 1: General principles and
1:2003 methods (ISO 14698-1:2003)
EN Cleanrooms and associated controlled environments -
24 ISO14698- Biocontamination control - Part 2: Evaluation and interpretation
2：2003 of biocontamination data (ISO 14698-2:2003)
EN 62366-
Medical devices - Part 1: Application of usability engineering to medical
25 1:2015/A1:2
devices
020

Regulations and Non-harmonized standards

No. Reference Title
01 93/42/EEC EC Directive: Medical Devices Directive
02 MEDDEV 2.12/1 Medical devices vigilance system
rev.8
03 MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and notified bodies
rev4
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers
04 rev4 and notified bodies
05 GB15980:1995 Hygienic Standard for Single Use Medical Products
06 YY0167:2005 Non-absorbable surglcal suture
07 YY0033:2000 Management Criterion for the Sterile Medical Devices
Production
08 USP43 USP43

1.4 Appendix
CE2-01 Clean workshop environment test report
CE2-02 Workshop Layout
 File No. AG-TCF-1-04
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Sterile product quality assurance system drawing

Personnel decontamination procedures The
100,000 clean workshop provisions of Sterilization
sterilization tests
Changing shoes→coat off 1、≥0.5um dust，≤ dose
→washing one’s hand 3500000pc/litre
→putting on overalls Finished
→hand disinfection Wind speed≥0.25/ s， storehouse
R For
differential pressure≥10 Pa sterilized inspection
2、temperature：18-28℃， database
Logistics purification procedures
humidity：
Retention
45-65% Compute samples
De outsourcing→cleaning r record
→transfer window 3、air colonies：≤500 cfu/ m3
4、palm colonies：≤300 cfu/hand
5、table colonies≤10 cfu/ Cm2 Bacteria
Unit packing inspection,
6、sterilize 30min，2 times/day First attempt bacteria material
contamination≤ inspection
7、washing clothes，once/week 100cfu/g
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 File No. AG-TCF-1-04
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 File No. AG-TCF-1-04
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 File No. AG-TCF-1-04
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 File No. AG-TCF-1-04
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 File No. AG-TCF-1-04
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04. Product's manufacturing Rev. Date 2022.2.8

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 File No. AG-TCF-1-04
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Clean room (area) Integrated Performance Field

Test report
Report No. HA2021QR0253

Subjects Name Huaian Angel Medical Instruments Co., Ltd.

Clean room (area) name Production workshop and laboratory

Subjects Category Entrusted test

Huai'an City Food and drug inspection institute

Dec 21th ， 2021
 File No. AG-TCF-1-04
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04. Product's manufacturing Rev. Date 2022.2.8

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Statement
1、The report no “Huai'an City Food and drug inspection institute
” and “Huai'an City Food and drug inspection institute report special
chapter” invalid.
2、A copy of the report shall be stamped with the unit of inspection.
3、Test report no approval the signature is invalid.
4、The test report alter is invalid.
5、The test report are judged according to the relevant standards and design
requirements.
6、The test report is only responsible for the detection of the prevailing site
environment.
7、If there is any objection to the result of the inspection, please submit to the firm
with in 15days from the date of receipt of the report or apply to the higher level
testing institution for arbitration.
Communication information
Add: 5A F, Wisdom Valley, No.19, Meigao Road, Economic and Technological
Development Zone, Huaian City, China
Postcode: 223300
Tel: 0517-83661713
Fax: 0517-83647092
 File No. AG-TCF-1-04
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04. Product's manufacturing Rev. Date 2022.2.8

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Test report

Test category Commissioning test Source Huaian Angel Medical Instruments

task Co., Ltd.
Inspected unit Huaian Angel Medical Instruments Address NO.19, East zhuhai road Huaian City
Co., Ltd.

TEX 13064903784 Postcode 223001

Cleansing Production 100000 21 area：996M2 Non-

workshop Class unidirectional
Subjects flow

Regional Laboratory 10000 5 rea：24M2 Non-

Class unidirectional
Name flow

Relative
Temperation
Outdoor weather sunny 2 Humidity 55
（0C）
（%）

Test Status Static

Detect and
YY0033-2000 (Production of sterile medical equipment management standards)
determine basis

Detection
Compliance
Conclusion

Preparation : Yang kun

Audit : Liu Yan
Approval :
Dec 18,2021
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Clean room (area) performance test results

Inspection unit: Huaian Angel Medical Instruments Co., Ltd. Clean room (area) name: production workshop and laboratory

Ordinal number 1 2 3 4 5 6
Static pressure
Relative
temperature ventilation settling microbe difference（pa）
Test item humidity Suspended particles（one\m³）
(℃) rate(time/h) (a dish) Between different
（%）
cleanliness levels conclusion
Hundreds of ≥0.5μm ≥5μm
Hundreds of level：
level：≥15 Hundreds of level：≤ Hundreds of level：≤
standard code 18℃-28℃ 45%-65% ≤10 ≥5
10 ~ 5 level ：≥ 3500000 20000
10 ~ 5 level ：≤3
20 10 ~ 5 level ：≤350000 10 ~ 5 level ：≤2000
Detection area Testing data
NO.2 Men's locker 5（ for no.1 Men's
room 22 53 32 0 locker room<No.1 29317 11607 pass
（No.1 workshop） workshop>）
NO.2 women s locker 6（ for no.1 Women's
room 22 52 19 0 locker room<No.1 11079 2877 pass
（No.1 workshop） workshop>）
Sanitary ware room
23 53 31 0 \ 3066 778 pass
（No.1 workshop）
Laundry room
23 54 15 0 \ 4543 2512 pass
（No.1 workshop）
No.1 Assembly room
22 53 15 0 \ 1722 357 pass
（No.1 workshop）
No.2 Assembly room
22 54 17 0 \ 927 154 pass
（No.1 workshop）

Clean corridor
24 53 17 0 \ 1909 271 pass
（No.1 workshop）

Washing room
23 54 25 0 \ 602 964 pass
（No.1 workshop）
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6（for no.1 Men's locker

NO.2locker room
23 53 23 0 room<No.2 105000 10211 pass
（No. 2 workshop）
workshop>）
Assembly room
22 53 20 0 \ 165044 939 pass
（No. 2 workshop）
Washing room
24 53 15 0 \ 101102 753 pass
（No. 2 workshop）
Sanitary ware room
22 54 29 0 \ 47057 601 pass
（No. 2 workshop）
Buffer room
24 53 21 4 \ 81115 700 pass
（No. 2 workshop）
 File No. AG-TCF-1-04
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Clean room (area) performance test results

Inspection unit: Huaian Angel Medical Instruments Co., Ltd. Clean room (area) name: production workshop and laboratory
Ordinal number 1 2 3 4 5 6
Static pressure
Relative
temperature ventilation settling microbe difference（pa）
Test item humidity Suspended particles（one\m³）
(℃) rate(time/h) (a dish) Between different
（%）
cleanliness levels conclusion
Hundreds of ≥0.5μm ≥5μm
Hundreds of level：
level：≥15 Hundreds of level：≤ Hundreds of level：≤
standard code 18℃-28℃ 45%-65% ≤10 ≥5
10 ~ 5 level ：≥ 3500000 20000
10 ~ 5 level ：≤3
20 10 ~ 5 level ：≤350000 10 ~ 5 level ：≤2000
Detection area Testing data
NO.2 Women's locker
5(for NO.1 Men's locker
room 22 57 21 0 7022 109 pass
room<No.3 workshop>)
（No.3 workshop）
NO.2Man’s locker 5(for NO.1 women s
room 22 58 26 0 locker room<No.3 37457 1222 pass
（No.3 workshop） workshop>)
Washing room
22 57 31 0 \ 17091 2139 pass
（No.3 workshop）

Sanitary ware room

23 53 38 0 \ 33009 1211 pass
（No.3 workshop）

cleaning room
24 55 32 0 / 63101 3021 pass
（No.3 workshop）
No.1 Assembly room
23 54 20 0 / 448000 421 pass
（No.3 workshop）
No.2 Assembly room
23 54 16 0 / 170007 3009 pass
（No.3 workshop）
buffer
24 56 16 0 / 32500 3321 pass
（No. 3 workshop）
NO.2 locker room 8（for NO.1 locker
21 50 24 4212 1423 pass
（laboratory） 0 room<laboratory>）
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Sterile room 13（forClean

21 52 113 0 6077 1334 pass
（laboratory） corridor<laboratory>）
Positive control room 14（for Clean
21 53 37 0 104411 1009 pass
（laboratory） corridor<laboratory>）
Clean corridor -18（for Clean
21 51 41 0 7321 854 pass
（laboratory） corridor<laboratory>）
microbial limit room 10（for
21 52 81 0 12099 1343 pass
（laboratory） buffer<laboratory>）
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Appendix
The main inspection equipment:
Appellation Type Condition
Differential pressure TESTO 512 PASS
gauge

Temperature and HT-3005HA PASS

humidity meter
Dust particle counter LASAIRIII5100 PASS

Air flow meter TS18380 PASS

Remark: Blank Below

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CE2-02
 File No. AG-TCF-1-04
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Zhangjiagang Municipal CNNC Huakang Radiation CO., Ltd.

Test Report
Sample Name Non-absorbable suture needles with thread Inspection date November 17, 2008
Censored units Huaian Angel Medical Instruments Co., Ltd. Test item Initial bacterial contamination
Number of samples 5
Reporting date November 19, 2008

1.0 Testing methods

Based on ISO11737-1: 2006 Sterilization of medical devices - Microbiological methods - Part 1:
Determination of the total number of microbial products, the initial contamination of the products
tested bacteria.

2.0 Test results

After the initial recovery rate of confirmed bacterial contamination, the initial pollution of bacteria
in the table below
The results of the initial bacterial contamination (CFU/SIP)
Sample number(SIP=1) initial bacterial contamination(CFU/per item)

1 85

2 55

3 75

4 80

5 90

Average 77

The results are only responsible for the sent sample, the results reference to other products，it can
only be the responsibility of the manufacturer.

Inspection Xu Wenxiong Auditing Date November 19, 2008

Address: Lu Zhang Venture Road,Fenghuang Town, Zhangjiagang
Post code： 215614 Telephone:0512-58421200
 File No. CE09
Technical File Rev. No. D
Rev. Date 2016.06.28
9. Product's manufacturing process
Page 23

CE09-03