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验证文件
Verify the documents

二类产品（外包装为吸塑盒）三年货架有效期验证报告
Verification report of the three-year shelf life of Class II products (outer packaging is blister box).

验证编号：YZBG-03.67-2023
Verification Number: YZBG-03.67-2023

拟制/日期：
Preparation/Date:

审核/日期：
Review/Date:

批准/日期：
Approval/Date:

安徽万维医疗科技有限公司
Anhui Wanwei Medical Technology Co., Ltd

目录
directory

验证目的
Verification Purposes

验证样品选择
Verify sample selection

验证方案
Validate the scheme

验证日期
Verification date

验证依据
Verification basis

验证人员
Verifiers

验证内容
Verify the content

验证记录
Verify records

九、验证结论
9. Verify the conclusion

验证目的
Verification Purposes

我司以吸塑盒为外包装的现有产品（一次性射频等离子体手术刀头(电极)、手术微创解剖器（手术切割器）、一次性治疗刀头、一次性消融切割器、一次性射频等离子体手术电极（切割器）套件）的货架有效期原为灭菌后两年；应市场需求，需验证是否满足货架有效期为三年，故需验证其三年有效期的合理性和稳定性。
The shelf life of our existing products (disposable radiofrequency plasma scalpel head (electrode), surgical minimally invasive dissecter (surgical cutter), disposable treatment cutter head, disposable ablation cutter, disposable radiofrequency plasma surgical electrode (cutter) kit) with blister box as the outer packaging was originally two after sterilizationyears; In response to market demand, it is necessary to verify whether the shelf life is three years, so it is necessary to verify the rationality and stability of its three-year validity period.

二、验证样品选择
2. Verify sample selection

2.1应选择产品组成结构、材料最全面的型号作为验证样品；
2.1 The model with the most comprehensive product composition and material should be selected as the verification sample;

2.2一次性射频等离子体手术刀头(电极)、手术微创解剖器（手术切割器）、一次性治疗刀头、一次性消融切割器、一次性射频等离子体手术电极（切割器）套件产品组成结构相似，且所用包装一致，无差别。我司现有量产最多的型号为VF06E ,使用的初包装规格具有显著代表性（80%型号所用），且VF06E中的材料种类多（PVC、ABS、陶瓷、钨、PVDF、PEEK、PI、PU等），故选择一次性射频等离子体手术刀头(电极)中的VF06E作为验证代表样品。
2.2 Disposable radiofrequency plasma scalpel head (electrode), surgical minimally invasive dissecter (surgical cutter), disposable treatment cutter head, disposable ablation cutter, and disposable radiofrequency plasma surgical electrode (cutter) kit are similar in composition and structure, and the packaging used is the same, and there is no difference. The VF 06E is the most mass-produced model at present, and the initial packaging specifications used are representative (80% of the models) and the material variety of V F06E is widespread(PVC, ABS, ceramic, tungsten, PVDF, PEEK, PI, PU, etc.), so V F06E in disposable RF plasma scalpel head (electrode) was selected as the representative sample for verification.

三、验证方案
3. Verification scheme

目前验证其有效期有两种方式，自然老化方式（自然时间达到三年）和加速老化方式（模拟三年的存放周期）。因为加速老化方式比自然老化方式验证速度快，周期短，故我司选用加速老化方式（模拟三年的存放周期）作为货架有效期的验证方法。
At present, there are two ways to verify its expiration date, the natural aging method (natural time reaches three years) and the accelerated aging method (simulating a three-year storage cycle). Because the accelerated aging method is faster and shorter than the natural aging method, our company chooses the accelerated aging method (simulating a three-year storage cycle) as the verification method for the shelf life.

通过产品的老化试验验证其包装的方式等是否满足我司制定的标准要求（有效期三年）。
Through the aging test of the product, we verify whether the packaging method meets the standard requirements set by our company (valid for three years).

四、验证日期：
4. Verification Date:

五、验证依据
5. Verification basis

YY/T 0681.1-2018无菌医疗器械包装试验方法　第1部分：加速老化试验指南
YY/T 0681.1-2018 Test methods for sterile medical device packaging Part 1: Guidelines for accelerated aging tests

六、验证人员
6. Verifiers

姓名 Name	部门 department	任职 Appointment	职责 Responsibilities
代松伟 Dai Songwei	质量部 Quality Department	组长 Group leader	批准验证方案和验证报告。 Approve the validation protocol and validation report.
罗涛 Luo Tao	技术部 Technical Department	组员 Group members	负责验证方案、验证报告审核。 Responsible for the review of the verification scheme and verification report.
魏子尧 Wei Ziyao 张宜宽 Zhang Yikuan	技术部 Technical Department	组员 Group members	负责验证方案、验证报告的具体实施及数据记录。 Responsible for the specific implementation of the verification plan, verification report and data recording.
张玉玲 Zhang Yuling	质量部 Quality Department	组员 Group members	负责验证方案、验证报告的编制，验证时的检测及数据记录。 Responsible for the preparation of verification schemes, verification reports, testing and data recording during verification.
章玉凤 Zhang Yufeng	生产部 Production Department	组员 Group members	负责配合技术完成验证。 Responsible for cooperating with technology to complete verification.

七、验证内容
7. Verification content

7.1使用设备
7.1 Use of Equipment

序号 serial number	设备名称 The name of the device	设备型号 Device model	设备编号 Device number	是否在校准有效期内 Whether it is within the validity period of the calibration
1	医用洁净工作台 Medical clean bench	BBS-DDC	ZL-2020-42	□是□否 □ Yes□ No
2	智能集菌仪 Intelligent Bacteria Collector	ZW-808A	ZL-2020-48	□是□否 □ Yes□ No
3	电热恒温鼓风干燥箱 Electrically heated constant temperature blast drying oven	DHG-9101-2A	ZL-2020-04	□是□否 □ Yes□ No
4	恒温恒湿培养箱 Constant temperature and humidity incubator	LHP-160E	ZL-2020-03(01)	□是□否 □ Yes□ No
5	恒温恒湿培养箱 Constant temperature and humidity incubator	LHP-160E	ZL-2020-03(02)	□是□否 □ Yes□ No
6	耐压测试仪（配套） Hipot Tester (Matching)	BF2670AM	ZL-2020-11（02）	□是□否 □ Yes□ No
7	万用表√ Multimeter √	ZTY890D	ZL-2021-13（06）	□是□否 □ Yes□ No
8	测试工装 Test fixtures	PLA-600	ZL-2022-014	/

7.2样品信息
7.2 Sample Information

产品型号 Product model	VF06E
生产日期/生产批次 Date of manufacture/batch of production	2023.02.01/230201
灭菌日期/灭菌批次 Sterilization date/sterilization batch	2023.02.13/230201
老化数量 Number of aging	35
包装方式 Packing:	PETG吸塑盒+1059B特卫强盖材 PETG blister box + 1059B Tyvek lid

7.3加速老化周期
7.3 Accelerate the aging cycle

7.3.1老化公式
7.3.1 Aging formula

AAF=Q₁₀^【（T^AA-TRT^）/¹⁰^】

AAT=RT/AAF

其中：
Thereinto:

AAF：加速老化因子；
AAF: accelerated aging factor;

Q₁₀：老化因数，通常为2；
Q₁₀: Aging factor, usually 2;

TAA：加速老化温度，单位℃；
TAA: accelerated aging temperature, unit: °C;

TRT：环境温度，单位℃；
TRT: ambient temperature, in °C;

AAT：达到自然老化时间三年的实际时长；
AAT: the actual time to reach the natural aging time of three years;

RT：通常为365。
RT: Usually 365.

7.3.2老化时间计算
7.3.2 Calculation of aging time

如上定加速老化温度55℃，产品存储温度25℃，Q₁₀取值2，可计算出加速老化因子：
If the accelerated aging temperature is set at 55 °C, the product storage temperature is 25 °C, and the value of Q ₁₀ is 2, the accelerated aging factor can be calculated

AAF= Q₁₀^【（T^AA-TRT^）/¹⁰^】= 2^【（^55-25^）/¹⁰^】=2³=8，AAT=365/8=45.6天。
AAF= Q₁₀^【（T^AA-TRT^）/¹⁰^】= 2^【（^55-25^）/¹⁰^】=2³=8, AAT=365/8=45.6 days.

通过以上计算，模拟三年的存放周期加速老化时间需累计达到136.8天（每天24小时）。
Based on the above calculations, the accelerated aging time of the simulated three-year storage cycle needs to be accumulated to 136.8 days (24 hours per day).

7.4验证项目
7.4 Verification Items

序号 serial number	检验项目 Inspection items	0天 0 days	45.6天 45.6 days （自然存放一年） (Stored naturally for one year)	91.2天 91.2 days （自然存放两年） (Naturally stored for two years)	136.8天 136.8 days （自然存放三年） (Stored naturally for 3 years)
1	外观 appearance	√	√	√	√
2	无菌 asepsis	√	√	√	√
3	阻菌 Bacteriostatic bacterial	√	√	√	√
4	真空泄露性 Vacuum leakage	√	√	√	√
5	拉拔力 Pull-out force	√	√	√	√
6	渗透性 permeability	√	√	√	√
7	耐压性能 Pressure resistance	√	√	√	√
8	导通性能 Conduction performance	√	√	√	√
9	使用寿命 Service life	√	√	√	√

7.5检查方法及标准
7.5 Inspection methods and standards

7.5.1外观
7.5.1 Appearance

检查方法：根据7.4时间每次检查2个产品外观，观察产品及外包装是否有变色、变形、损坏的情况。
Inspection method: According to 7.4 time, check the appearance of 2 products each time, and observe whether the product and the outer packaging are discolored, deformed or damaged.

标准：产品及外包装无变色、变形、损坏的情况。
Standard: The product and the outer packaging are free of discoloration, deformation and damage.

7.5.2无菌
7.5.2 Sterility

检查方法：按7.4时间根据《无菌检验操作管理规范》检测产品无菌情况；
Inspection method: according to 7.4 time, test the sterility of the product according to the "Sterility Inspection Operation Management Specification";

标准：无菌。
Standard: Sterile.

7.5.3阻菌
7.5.3 Bacteriostatic bacterial

检验方法：
Test Method:

1）按7.4时间取做过无菌检测产品的盖材，在无菌室内将热合纸裁剪2个长宽为50mm的正方形送去灭菌，确保热合纸本身无菌状态；
1) According to 7.4 time, take the cover material of the sterility test product, cut the heat-sealed paper into two squares with a length and width of 50mm in the sterile room and send them for sterilizationEnsure that the heat-sealing paper itself is sterile;

2）将2片灭菌样品内表面完全平铺于胰酪大豆胨琼脂培养基中；
2) The inner surface of the 2 pieces of sterilized samples was completely tiled in pancreatic cheese soybean peptone agar medium;

3）在阳性室内取不大于100cfu/mL的金黄色葡萄球菌菌悬液5滴，每滴0.1mL，均匀的滴在每片样品外表面，互不接触；
3) Take 5 drops of Staphylococcus aureus suspension no more than 10 0 cfu/mL in the positive chamber, 0.1mL per drop, evenly on the outer surface of each sample, without touching each other;

4）在18～28℃，湿度45%～60%条件下干燥4小时；
4) Dry at 18~28 °C, humidity 45 ~ 60% 4 Hour;

5)将营养琼脂培养基放置在恒温恒湿培养箱中培养48小时，观察其内表面细菌生长情况。
5)Nutrient agar medium was placed in a constant temperature and humidity incubator for 48 hours to observe the bacterial growth on its inner surface.

标准：培养基表面无菌生长，老化后盖材阻菌性能无异常。
Standard: The surface of the medium grows aseptically, and there is no abnormality in the antibacterial performance of the cap material after aging.

7.5.4真空泄露性
7.5.4. Vacuum leakage

检查方法：按7.4时间根据《YY/T 0681.5-2010无菌医疗器械试验方法第5部分内压法检测粗大泄露（气泡法）》检验产品初包装真空泄露性。
Inspection method: According to 7.4 time, according to the "YY/T 0681.5-2010 sterile medical device test method Part 5 internal pressure method to detect gross leakage (bubble method)" to check the vacuum leakage of the initial packaging of the product.

标准：个别气泡或无气泡泄露。
Standard: Individual bubbles or no bubble leakage.

7.5.5拉拔力
7.5.5. Pulling force

检查方法：按7.4时间根据《YY/T 0681.2-2010 无菌医疗器械试验方法第2部分：软性屏障材料的密封强度》、《YY/T 0698.5-2009 最终灭菌医疗器械包装材料第5部分：透气性材料与塑料膜组成的可密封组合袋和卷材要求和试验方法》检验老化后封口位置拉拔力。
Inspection method: according to 7.4 time according to "YY/T 0681.2-2010 Test methods for sterile medical devices Part 2: Sealing strength of soft barrier materials" and "YY/T 0698.5-2009 Packaging materials for terminally sterilized medical devices". Part 5: Sealable combination bags and coils composed of breathable materials and plastic film Requirements and test methods to test the pull-out force of the sealing position after aging.

标准：拉拔力≥1.5N；
Standard: pull-out force≥ 1.5N;

7.5.6渗透性
7.5.6. Permeability

检查方法：按7.4时间根据《ASTM F 1929-2005染色渗透法测试包装密封性》检验初包装密封性能。
Inspection method: According to 7.4 time, according to the "ASTM F 1929-2005 dyeing penetration method to test the tightness of packaging", the sealing performance of the initial packaging is inspected.

标准：染色料无渗漏。
Standard: No leakage of coloring matter.

7.5.7耐压性能
7.5.7. Withstand voltage

检验方法：按7.4时间根据产品成品检验标准，检验产品耐压性能。
Inspection method: According to 7.4 time, according to the finished product inspection standard, check the pressure resistance of the product.

标准：无击穿、无闪络、无报警（0.5mA限值）。
Standard: no breakdown, no flashover, no alarm (0.5mA limit).

7.5.8导通性能
7.5.8. Conduction performance

检验方法：按7.4时间根据产品成品检验标准，检验产品导通性能。
Inspection method: According to 7.4 time, according to the finished product inspection standard, check the conduction performance of the product.

标准：电极丝、外钢管和插头的电阻≤10Ω。
Standard: Resistance ≤ 10 Ω for electrode wires, outer tubes, and plugs.

7.5.9使用寿命
7.5.9 Service life

检验方法：按7.4时间连接测试工装（PLA-600），将工装输出功率调制最大，产品放入生理盐水后持续输出，检验产品使用寿命。
Inspection method: according to 7.4 time connection test tooling (PLA-600), the output power of the tooling is maximized, and the product is continuously output after being put into normal saline, and the service life of the product is checked.

标准：可正常识别工装（PLA-600），且在最大功率下，可持续运行20分钟。
Standard: The tooling (PLA-600) can be recognized normally, and at maximum power, it can last for 20 minutes.

八、验证记录
8. Verification Records

8.1外观
8.1 Appearance

老化时间 Aging time	检验日期 Date of inspection	外观检验 Visual inspection	是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		是否符合要求 Whether it meets the requirements	样品1 Sample 1	样品2 Sample 2
0天 0 days			□是□否 □ Yes□ No
45.6天 45.6 days			□是□否 □ Yes□ No
91.2天 91.2 days			□是□否 □ Yes□ No
136.8天 136.8 days			□是□否 □ Yes□ No
检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.2无菌
8.2 Sterility

老化时间 Aging time	检验日期 Date of inspection	无菌检验 Sterility testing	是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		是否符合要求 Whether it meets the requirements	样品1 Sample 1	样品2 Sample 2
0天 0 days			□是□否 □ Yes□ No
45.6天 45.6 days			□是□否 □ Yes□ No
91.2天 91.2 days			□是□否 □ Yes□ No
136.8天 136.8 days			□是□否 □ Yes□ No
检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.3阻菌性
8.3 Bacteriostatic property

老化时间 Aging time	检验日期 Date of inspection	阻菌性检验 Bacteriostatic test	是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		是否符合要求 Whether it meets the requirements	样品1 Sample 1	样品2 Sample 2
0天 0 days			□是□否 □ Yes□ No
45.6天 45.6 days			□是□否 □ Yes□ No
91.2天 91.2 days			□是□否 □ Yes□ No
136.8天 136.8 days			□是□否 □ Yes□ No
检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.4真空泄露性
8.4 Vacuum leakage

老化时间 Aging time	检验日期 Date of inspection	真空泄露性检验 Vacuum leakage test		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.5拉拔力
8.5 Pulling force

老化时间 Aging time	检验日期 Date of inspection	拉拔力检验 Pull-out force test		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.6渗透性
8.6 Permeability

老化时间 Aging time	检验日期 Date of inspection	渗透性检验 Permeability test		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.7耐压性能
8.7 Pressure resistance

老化时间 Aging time	检验日期 Date of inspection	耐压性能检验 Withstand voltage performance test		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.8导通性能
8.8 Conduction performance

老化时间 Aging time	检验日期 Date of inspection	导通性能检验 Conduction performance test		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

8.9使用寿命
8.9 Service life

老化时间 Aging time	检验日期 Date of inspection	使用寿命检验 Service life inspection		是否符合要求 Whether it meets the requirements
老化时间 Aging time	检验日期 Date of inspection		样品1 Sample 1	是否符合要求 Whether it meets the requirements	样品2 Sample 2	样品3 Sample 3
0天 0 days				□是□否 □ Yes□ No
45.6天 45.6 days				□是□否 □ Yes□ No
91.2天 91.2 days				□是□否 □ Yes□ No
136.8天 136.8 days				□是□否 □ Yes□ No
	检验人/日期：复核人/日期： Reviewer/Date: Reviewer/Date:

九、验证结论
9. Verify the conclusion

通过对老化产品外观、无菌、阻菌性、真空泄露性、拉拔力、渗透性、耐压性能、导通性能、使用寿命的持续检测，我司以吸塑盒为外包装的现有二类产品（一次性射频等离子体手术刀头(电极)、手术微创解剖器（手术切割器）、一次性治疗刀头、一次性消融切割器、一次性射频等离子体手术电极（切割器）套件）三年有效期的合理性和稳定性符合要求，故现将以上产品货架有效期定为灭菌后三年。
Through the continuous testing of the appearance, sterility, antibacterial, vacuum leakage, pull-out force, permeability, pressure resistance, conduction performance, and service life of aging products, our company uses blister boxes as the outer packaging of the existing Class II products(Disposable radiofrequency plasma scalpel head (electrode), surgical minimally invasive dissecter (surgical cutter), disposable treatment cutter head, disposable ablation cutter, disposable radiofrequency plasma surgical electrode (cutter) kit) The three-year validity period of the three-year validity period meets the requirements, so the shelf life of the above products is now set at three years after sterilization.