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目录
Table of contents

序号 serial number	项目名称 Project name	页码 page number
1	导管质量检验原始记录（外观） Original record of catheter quality inspection (appearance)
2	导管质量检验原始记录（弯曲疲劳） Original record of catheter quality inspection ( bending fatigue )
3	导管质量检验原始记录（剥离强度） Original record of catheter quality inspection (peel strength)
4	导管质量检验原始记录（峰值拉力） Original record of catheter quality inspection (peak pulling force)
5	导管质量检验原始记录（弯曲疲劳） Original record of catheter quality inspection (bending fatigue)
6	导管质量检验原始记录（弯曲疲劳） Original record of catheter quality inspection (bending fatigue)
7	导管质量检验原始记录（电学性能） Original record of catheter quality inspection ( electrical performance )
8	导管质量检验原始记录（温度感应精度） Original record of catheter quality inspection (temperature sensing accuracy)
9	导管质量检验原始记录（化学性能） Original record of catheter quality inspection (chemical properties)
10	导管质量检验原始记录（真空泄露） Original record of catheter quality inspection ( vacuum leak )
11	导管质量检验原始记录（染料渗透） Original record of catheter quality inspection ( dye penetration )
12	导管质量检验原始记录（微生物屏障） Original record of catheter quality inspection ( microbial barrier )
13	导管质量检验原始记录（气泡试验） Original record of catheter quality inspection ( bubble test )
14	导管质量检验原始记录（剥离强度） Original record of catheter quality inspection ( peel strength )
15	导管质量检验原始记录（峰值拉力） Original record of catheter quality inspection (peak pulling force)
16	导管质量检验原始记录（尺寸） Original record of catheter quality inspection (dimensions)

导管质量检验原始记录（外观） Original record of catheter quality inspection (appearance)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.1 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.1

概述及合格标准
Overview and Eligibility Criteria

外观：当用正常视力或矫正视力在放大2.5倍的条件下检查时，消融导管有效长度的外表面应清洁无杂质。消融导管有效长度外表面，包括末端，不应有加工和表面缺陷。
Appearance: When examined under 2.5x magnification with normal or corrected vision , the outer surface of the effective length of the ablation catheter should be clean and free of impurities. The outer surface of the effective length of the ablation catheter, including the tip, should be free of machining and surface defects.

外包装、内包装标识清晰、完整、正确，箱内产品与箱外标识一致，无漏装、组装等不良现象；
The markings on the outer and inner packaging are clear, complete and correct, the products inside the box are consistent with the markings outside the box, and there are no defects such as missing packaging or assembly;

外包装无破损、无污染；吸塑良好，无漏吸、烧黑现象。
The outer packaging is not damaged or polluted; the blister is in good condition, and there is no leakage or blackening.

每个消融导管单包装上有：产品名称、外径、有效长度、制造商名称或注册商标和地址、生产批号、失效日期或使用截止日期、任何特殊贮存或搬运说明、无菌标志、灭菌方法、一次性使用标记。
Each ablation catheter single package contains: product name, outer diameter, effective length, manufacturer's name or registered trademark and address, production batch number, expiration date or use-by date, any special storage or handling instructions, sterility mark, sterilization Methods, single use markers.

结果
result

序号 serial number	结果 result	序号 serial number	结果 result	序号 serial number	结果 result
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations

检验结论：□符合规定 □不符合规定
Inspection conclusion: □Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date: Date:

导管质量检验原始记录（弯曲疲劳） Original record of catheter quality inspection (bending fatigue)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.2 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7. 2

概述及合格标准
Overview and Eligibility Criteria

将消融导管放在弯曲模型中，反复推拉10次后旋转180°推拉10次，消融导管外观应无明显脱胶、开裂、断裂不良现象，同时符合消融导管导通性的要求。
Place the ablation catheter in the curved model, push and pull it repeatedly 10 times, then rotate it 180 ° and push and pull it 10 times. The appearance of the ablation catheter should have no obvious degumming, cracking, or fracture defects, and it should also meet the requirements for conductivity of the ablation catheter.

结果
result

序号 serial number	结果 result	序号 serial number	结果 result	序号 serial number	结果 result
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations
	□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations		□符合规定 □ 不符合规定 □Conforms to regulations □ Does not comply with regulations

检验结论：□符合规定 □不符合规定
Inspection conclusion: □Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（电学性能） Original record of catheter quality inspection (electrical performance)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.3、 7.4、 7.5 "Renal artery radiofrequency ablation catheter shelf life plan GL-YF-RDN-JG- 019 " 7.3 , 7.4 , 7.5

概述及合格标准
Overview and Eligibility Criteria

直流电阻：消融导管各电极与对应射频线尾线插孔芯脚应导通，阻值为3.0±1.0Ω；
DC resistance: Each electrode of the ablation catheter and the corresponding RF cable tail jack pin should be connected, and the resistance value is 3.0 ± 1.0 Ω;

电极间绝缘电阻：消融导管任一电极与其他电极对应尾线插孔芯脚之间的绝缘电阻应大于5MΩ，消
Insulation resistance between electrodes: The insulation resistance between any electrode of the ablation catheter and the corresponding tail wire jack core of other electrodes should be greater than 5M Ω.

电极与外管间绝缘电阻：消融导管七腔管与手柄插孔所有芯脚之间的绝缘电阻应大于5MΩ；
Insulation resistance between the electrode and the outer tube: The insulation resistance between the seven- lumen tube of the ablation catheter and all core pins of the handle jack should be greater than 5M Ω;

仪器
instrument

仪器 instrument
名称 name	编号 serial number	其它 other
电桥测量仪 Bridge measuring instrument		/
绝缘电阻表 Insulation resistance meter		/

结果
result

样品序列号 Sample serial number	序号 serial number	直流电阻3.0±1.0Ω DC resistance 3.0 ± 1.0 Ω	电极间绝缘电阻 Insulation resistance between electrodes
样品序列号 Sample serial number	序号 serial number	直流电阻3.0±1.0Ω DC resistance 3.0 ± 1.0 Ω				消融导管任一电极与其他电极对应尾线插孔芯脚之间的绝缘电阻应大于5MΩ The insulation resistance between any electrode of the ablation catheter and the corresponding tail wire jack pins of other electrodes should be greater than 5M Ω		电极与外管间绝缘电阻：消融导管七腔管与手柄插孔所有芯脚之间的绝缘电阻应大于5MΩ Insulation resistance between the electrode and the outer tube: The insulation resistance between the seven- lumen tube of the ablation catheter and all core pins of the handle jack should be greater than 5M Ω
	1#电极 1# electrode		/
	1#电极 1# electrode
		2#电极 2# electrode		/	/
		2#电极 2# electrode
		3#电极 3# electrode		/	/	/
		3#电极 3# electrode
		4#电极 4# electrode		/	/	/
		4#电极 4# electrode				/
		5#电极 5# electrode		/	/	/
		5#电极 5# electrode				/	/
		6#电极 6# electrode		/	/	/
		6#电极 6# electrode				/	/	/

检验结论：□符合规定 □不符合规定
Inspection conclusion: □Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（温度感应精度） Original record of catheter quality inspection ( temperature sensing accuracy )
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.6 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7. 6

概述及合格标准
Overview and Eligibility Criteria

温度感应精度：测温范围0-99℃，测温误差应不大于±3℃。
Temperature sensing accuracy : temperature measurement range 0-99 ℃ , temperature measurement error should not be greater than ± 3 ℃.

仪器及设备
Instruments and equipment

名称 name	编号 serial number
肾动脉射频消融仪 Renal artery radiofrequency ablation device
恒温水浴锅 Constant temperature water bath
标准温度计 standard thermometer

结果
result

温度感应精度：测温范围0-99℃，测温误差应不大于±3℃
Temperature sensing accuracy: temperature measurement range 0-99 ℃ , temperature measurement error should not be greater than ± 3 ℃

序列号
serial number

结果
result

设备显示温度
Device displays temperature

3℃

50℃
50 ℃

显示值
Display value

实测值
Actual value

误差值
error value

显示值
Display value

实测值
Actual value

误差值
error value

□符合规定
□Conform to regulations

□不符合规定
□Does not comply with regulations

通道1
Channel 1

通道2
Channel 2

通道3
Channel 3

通道4
Channel 4

通道5
Channel 5

通道6
Channel 6

设备显示温度
Device displays temperature

97℃
97 ℃

显示值
Display value

实测值
Actual value

误差值
error value

通道1
Channel 1

通道2
Channel 2

通道3
Channel 3

通道4
Channel 4

通道5
Channel 5

通道6
Channel 6

检验结论：□符合规定 □不符合规定
Inspection conclusion: □Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（化学性能） Original record of catheter quality inspection (chemical properties)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.7、7.8、7.9、7.10、7.11、7.12 "Renal artery radiofrequency ablation catheter shelf validity plan GL-YF-RDN-JG- 019 " 7.7 , 7.8 , 7.9 , 7.10 , 7.11 , 7.12

概述及合格标准
Overview and Eligibility Criteria

耐腐蚀性：将样品浸入浓度{c(NaCI)=0.15mol/L的氯化钠溶液内，在室温下放置5h取出试样浸入沸腾的蒸馏水中持续30min。然后将蒸馏水和试样一起冷却至37℃，并在此温度下保温48h。取出试样，在室温下干燥。导管的金属部件不应有腐蚀痕迹。
Corrosion resistance: Immerse the sample into a sodium chloride solution with a concentration { c( NaCI )=0.15mol/L , place it at room temperature for 5 hours , take out the sample and immerse it in boiling distilled water for 30 minutes . Then the distilled water and the sample were cooled to 37 °C and kept at this temperature for 48 h . Take out the sample and dry it at room temperature. Metal parts of the conduit should show no signs of corrosion .

还原物质：精确量取检验液10ml,置于250ml碘量瓶中，精密加入硫酸溶液1ml和高锰酸钾标准溶液10ml,煮沸3min，迅速冷却，加碘化钾0.1g，密塞，摇匀。立即用硫代硫酸钠标准溶液滴定至淡黄色，再加5滴淀粉指示液，继续用硫代硫酸钠标准溶液滴定至无色。用同样的方法滴定空白对照液。检验液与同体积的同批空白对照液相比，高锰酸钾溶液消耗量之差不应超过2.0mL
Reducing substances: Accurately measure 10 ml of the test solution, place it in a 250 ml iodine volume bottle, accurately add 1 ml of sulfuric acid solution and 10 ml of potassium permanganate standard solution , boil for 3 minutes , cool quickly, add 0.1 g of potassium iodide , seal tightly, and shake well . Immediately titrate with sodium thiosulfate standard solution to light yellow, add 5 drops of starch indicator solution, and continue titrating with sodium thiosulfate standard solution until colorless. Use the same method to titrate the blank control solution. Compared with the same volume of blank control solution from the same batch, the difference in consumption of potassium permanganate solution should not exceed 2.0mL.

重金属：精确量取检验液25ml于25ml纳氏比色管中，另取一支25ml纳氏比色管，加入铅标准溶液25ml，于上述两支比色管中分别加入乙酸盐缓冲液（Ph3.5）2ml，再分别加入硫代乙酰胺试液2ml，摇匀，放置2min，置白色背景下从上方观察，比较颜色深浅。样品管颜色不得比标准管深。
Heavy metals: Accurately measure 25 ml of the test solution into a 25 ml Nessler colorimetric tube , take another 25 ml Nessler colorimetric tube, add 25 ml of lead standard solution, and put it into the above two colorimetric tubes . Add 2ml of acetate buffer ( Ph3.5 ) , and then add 2ml of thioacetamide test solution respectively , shake well, leave for 2 minutes , observe from above on a white background, and compare the color depth. The sample tube must not be darker than the standard tube.

酸碱度：取检验液和空白对照液各100ml，用_PH计分别测定其_PH值,以两者之差不得超过1.5。
pH: Take 100 ml each of the test solution and blank control solution , and use a _pH meter to measure their _pH values . The difference between the two should not exceed 1.5 .

蒸发残渣：量取检验液50ml加入已于105℃至恒重蒸发皿中，在水浴上蒸干并在105℃恒温箱中干燥至恒重。同法测定空白对照液。不挥发物总质量应不超过2mg
Evaporation residue: Measure 50 ml of the test solution and add it to an evaporating dish that has been heated to constant weight at 105 ° C, evaporate to dryness on a water bath and dry to constant weight in a constant temperature oven at 105 °C . Determine the blank control solution in the same way. The total mass of non-volatile matter should not exceed 2mg

紫外吸光度：取检验液加入1cm比色皿，必要时用0.45μm的微孔滤膜过滤，在5h内用1cm比色皿以空白对照液为参比，在波长范围250nm～320nm内测定吸光度。吸光度应不大于0.1
Ultraviolet absorbance : Take the test solution and add it to a 1cm cuvette . If necessary, filter it with a 0.45 μm microporous filter. Within 5 hours , use a 1cm cuvette to use the blank control solution as a reference and measure in the wavelength range 250nm ~ 320nm. Absorbance. The absorbance should not be greater than 0.1

试剂及仪器
Reagents and instruments

仪器 instrument
名称 name	编号 serial number		备注 Remark
鼓风干燥箱 blast drying oven
紫外分光光度计 UV spectrophotometer
电子天平 electronic balance
pH计 pH meter
试剂 Reagents
名称 name	厂家/配制人 Manufacturer / formulator	批号 batch number	备注 Remark
1/5KMnO₄ 1 /5KM n O ₄			C₀=0.01mol/L C ₀ =0.01 mol /L
硫酸溶液 sulfuric acid solution
Na₂S₂O₃ Na ₂ S ₂ O ₃			C_S=_0.01___mol/L C _S =_ 0.01 ___ mol/L

导管质量检验原始记录（化学性能） Original record of catheter quality inspection (chemical properties)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.7、7.8、7.9、7.10、7.11、7.12 "Renal artery radiofrequency ablation catheter shelf validity plan GL-YF-RDN-JG- 019 " 7.7 , 7.8 , 7.9 , 7.10 , 7.11 , 7.12

名称 name	厂家/配制人 Manufacturer / formulator	批号 batch number	其它 other
碘化钾 Potassium iodide			/
淀粉指示液 Starch indicator liquid			/
醋酸盐缓冲液（pH=3.5） Acetate buffer (p H=3.5 )			/
硫代乙酰胺试液 Thioacetamide test solution			/
铅标准溶液 Lead standard solution			/

供试液制备
Preparation of test solution

供试液制备：取成品导管根，除手柄外，全部剪切成1cm小段，加入玻璃容器中，按照每根导管加入120ml的比例加水，加入实验室二级用水 ml，在37℃±1℃放置24h，将样品与液体分离，冷至室温，作为检验液。
Preparation of test solution: Take the finished catheter root, cut it into 1cm pieces except the handle, add it to the glass container, add water according to the proportion of 120ml for each catheter, add ml of laboratory secondary water, and keep at 37℃±1℃ Leave it for 24 hours, separate the sample from the liquid, cool to room temperature, and use it as the test solution.

空白对照液制备：取同体积实验室二级用水于玻璃容器内，在37℃±1℃恒温24h，冷至室温，作为空白对照液。
Preparation of blank control solution: Put the same volume of laboratory secondary water in a glass container, keep at a constant temperature of 37 ℃ ± 1 ℃ for 24 hours , and cool to room temperature to serve as a blank control solution.

操作及结果
Operations and results

耐腐蚀 Corrosion resistant
操作 operate	取样品浸入盛有盐水溶液的玻璃烧杯内，在室温下放置5h。试验时间为： Dip the sample into a glass beaker containing the saline solution and leave it at room temperature for 5 hours. The test time is: 年月日时分至时分。 Year, month, day , hour , minute to hour . 取出试样浸入沸腾的蒸馏水中持续30min。 Take out the sample and immerse it in boiling distilled water for 30 minutes . 然后将蒸馏水和试样一起冷却至37℃，并在此温度下保温48h。取出试样，在室温下干燥。目力检查试样的腐蚀痕迹。试验时间为： Then the distilled water and the sample were cooled to 37 °C and kept at this temperature for 48 h . Take out the sample and dry it at room temperature. Visually inspect the specimen for signs of corrosion . The test time is: 年月日时至年月日时。共计时 year month day time to year month day time. total time
序号 serial number	结果 result	序号 serial number	结果 result
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations		口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
质量标准 quality standards	经腐蚀试验后，导管的金属部件不应有腐蚀痕迹 After the corrosion test, the metal parts of the conduit should not show signs of corrosion

导管质量检验原始记录（化学性能） Original record of catheter quality inspection (chemical properties)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.7、7.8、7.9、7.10、7.11、7.12 "Renal artery radiofrequency ablation catheter shelf validity plan GL-YF-RDN-JG- 019 " 7.7 , 7.8 , 7.9 , 7.10 , 7.11 , 7.12

还原物质 reducing substances
操作 operate	精确量取检验液10 ml，置于250ml碘量瓶中，精密加入硫酸溶液 1 ml和高锰酸钾标准溶液 10 ml，煮沸3 min，迅速冷却，加碘化钾0.1 g，密塞，摇匀。立即用硫代硫酸钠标准溶液滴定至淡黄色，再加5滴淀粉指示液，继续用硫代硫酸钠标准溶液滴定至无色。 Accurately measure 10 ml of the test solution , place it in a 250 ml iodine volumetric flask, accurately add 1 ml of sulfuric acid solution and 10 ml of potassium permanganate standard solution , boil for 3 minutes , cool quickly, add 0.1 g of potassium iodide , seal tightly, and shake well. Immediately titrate with sodium thiosulfate standard solution to light yellow, add 5 drops of starch indicator solution, and continue titrating with sodium thiosulfate standard solution until colorless. 用同样的方法滴定空白对照液。 Use the same method to titrate the blank control solution . 消耗高锰酸钾溶液的体积：V=（V₀-V_S）C_S/C₀ The volume of potassium permanganate solution consumed: V = ( V ₀ -V _S ) C _S /C ₀
结果 result	硫代硫酸钠滴定溶液（ml） Sodium thiosulfate titration solution ( ml )			数据处理（ml） Data processing ( ml )		综合判定 Comprehensive judgment
结果 result		起始值 starting value	终点值 end value	消耗体积 Consumption volume	V	综合判定 Comprehensive judgment	V_平均 Vaverage
空白组 Blank group （V_O） ( VO )						□符合规定 □Conform to regulations □不符合规定 □ Does not comply with regulations
实验组 experimental group （V_S） ( VS )
实验组 experimental group （V_S） ( VS )
标准 standard	检验液与同体积的同批空白对照液相比，高锰酸钾溶液消耗量之差不应超过2.0mL Compared with the same volume of blank control solution from the same batch, the difference in consumption of potassium permanganate solution should not exceed 2.0mL.

重金属 heavy metal
操作 operate	精确量取检验液25ml于25ml纳式比色管中，另取一支25ml纳式比色管，加入铅标准液（ρ（Pb²⁺）=1ug/mL）25ml，于上述两支比色管中分别醋酸盐缓冲液（pH3.5）2ml，再分别加入硫代乙酰胺试液 2 ml，摇匀，放置2 min，置白色背景下从上方观察，比较颜色深浅。 Accurately measure 25 ml of the test solution into a 25 ml nano colorimetric tube, take another 25 ml nano colorimetric tube, add 25 ml of lead standard solution ( ρ ( Pb ²⁺ ) =1ug/mL ) , and add it to the above two Add 2 ml of acetate buffer ( pH 3.5 ) into a colorimetric tube , then add 2 ml of thioacetamide test solution , shake well, leave for 2 minutes , observe from above on a white background, and compare the color depth .
结果 result	实验结果 Experimental results	结果判定 Result judgment
		样品管（口深于口不深于）标准品管 Sample tube (mouth deeper than mouth but not deeper than) standard quality tube	口符合规定 □不符合规定 Mouth complies with regulations □ does not comply with regulations
		样品管（口深于口不深于）标准品管 Sample tube (mouth deeper than mouth but not deeper than) standard quality tube
标准 standard	样品管颜色不得比标准管深。 The sample tube must not be darker than the standard tube.

酸碱度 pH
操作 operate	取检验液和空白对照液各100ml，用pH计分别测量其pH值 Take 100 ml each of the test solution and blank control solution , and measure their pH values with a pH meter.
结果 result	PH值 pH value	PH值之差 Difference in pH value	综合判定 Comprehensive judgment
空白组 Blank group			口符合规定 Mouth meets regulations □不符合规定 □ Does not comply with regulations
实验组 experimental group
实验组 experimental group
标准 standard	检验液与空白液两者之差不得超过1.5。 The difference between the test solution and the blank solution shall not exceed 1.5 .

导管质量检验原始记录（化学性能） Original record of catheter quality inspection (chemical properties)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.7、7.8、7.9、7.10、7.11、7.12 "Renal artery radiofrequency ablation catheter shelf validity plan GL-YF-RDN-JG- 019 " 7.7 , 7.8 , 7.9 , 7.10 , 7.11 , 7.12

蒸发残渣
evaporation residue

操作
operate

恒重过程（g）
Constant weight process (g)

组别
Group

加样前（g）
Before adding sample ( g )

加样后（g）
After adding sample ( g )

不挥发物重量（mg）
Non-volatile matter weight ( mg )

综合判定
Comprehensive judgment

对照组
control group

口符合规定
Mouth meets regulations

□不符合规定
□ Does not comply with regulations

实验组
experimental group

标准
standard

不挥发物总质量应不超过2mg
The total mass of non-volatile matter should not exceed 2mg

紫外吸光度 UV absorbance
操作 operate	取一支1cm比色皿加入检验液，另取一支1cm比色皿加入空白溶液做为空白对照，在波长范围250nm～320nm内使用紫外可见分光光度计测量吸光度。 Take a 1cm cuvette and add the test solution, and take another 1cm cuvette and add the blank solution as a blank control . Use a UV-visible spectrophotometer to measure the absorbance in the wavelength range of 250nm to 320nm .
结果 result	实验结果 Experimental results	综合判定 Comprehensive judgment
		口吸光度≯0.1 □ 吸光度＞0.1 Oral absorbance ≯ 0.1 □ Absorbance > 0.1	口符合规定 Mouth meets regulations □不符合规定 □ Does not comply with regulations
		口吸光度≯0.1 □ 吸光度＞0.1 Oral absorbance ≯ 0.1 □ Absorbance > 0.1
标准 standard	吸光度应不大于0.1 The absorbance should not be greater than 0.1

检验结论：口符合规定 □不符合规定
Inspection conclusion: The mouth complies with the regulations □ does not comply with the regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（真空泄露） Original record of catheter quality inspection (vacuum leak)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.13 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.13

环境条件 environmental conditions	温度： temperature:		湿度： humidity:		大气压：101Kpa Atmospheric pressure: 101Kpa
包装类型 Packaging type	吸塑盒+透析纸 Blister box + dialysis paper		包装材料 packaging materials		PETG和特卫强 PETG and Tyvek
试验压力 Test pressure	-40Kpa
实验步骤 Experimental steps	对照组： Control group: 取1个样品作为对照样品，用不大于250μm针尖在对照样品制造一个已知的缺陷，并在缺陷周围画圈标记； Take one sample as a control sample, use a needle tip no larger than 250 μm to create a known defect in the control sample, and draw a circle mark around the defect; 把处理好的对照样品放入真空罐中，加入纯水，将对照样品浸没于水下约25mm深处，在-40kpa条件下，保持1min Put the processed control sample into a vacuum tank, add pure water, immerse the control sample under water at a depth of about 25mm , and keep it for 1 minute under -40 kpa conditions. 观察现象，对照组的画圈标记部位有明显的连续气泡产生。 Observing the phenomenon , there were obvious continuous bubbles in the circled marked area of the control group. 实验组： Experimental group: 把样品放入真空罐中，将样品浸没于水下约25mm深处，在-40kpa条件下坚持1min； Put the sample into a vacuum tank, immerse the sample under water to a depth of about 25mm , and hold it at -40kpa for 1 minute ; 持续观察，如果观察到有连续气泡冒出，则说明该样品包装已有破损，观察时间为1min Continuously observe. If continuous bubbles are observed, it means that the sample packaging has been damaged. The observation time is 1 minute. 释放真空，取下盖子，检查样品包装内是否有水，并记录情况。 Release the vacuum, remove the lid, check the sample package for water, and record the situation.
检验结果 Test results
样品序号 Sample serial number	泄露情况 Leakage	泄露位置 leak location	样品序号 Sample serial number	泄露情况 Leakage		泄露位置 leak location
1	-	-	16	-		-
2	-	-	17	-		-
3	-	-	18	-		-
4	-	-	19	-		-
5	-	-	20	-		-
6	-	-	21	-		-
7	-	-	22	-		-
8	-	-	23	-		-
9	-	-	24	-		-
10	-	-	25	-		-
11	-	-	26	-		-
12	-	-	27	-		-
13	-	-	28	-		-
14	-	-	29	-		-
15	-	-	30	-		-

检验结论：口符合规定 □不符合规定
Inspection conclusion: The mouth complies with the regulations □ does not comply with the regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（染料渗透） Original record of catheter quality inspection ( dye penetration )
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.14 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.14

试验条件 Test conditions	温度℃ Temperature℃			湿度% humidity %
染色液 staining solution	0.05%甲苯胺蓝染色液 0.05 % Toluidine Blue Staining Solution
试样制备：0.05%甲苯胺蓝指示液（取0.5g曲拉通X-100使用纯化水混合、搅拌，定容至100ml。取0.05g甲苯胺蓝加入到上述曲拉通溶液中，即为0.05%甲苯胺蓝指示液） Sample preparation: 0.05 % toluidine blue indicator solution (take 0.5g of triton X -100 , mix with purified water, stir, and dilute to 100ml . Take 0.05g of toluidine blue and add to the above triton solution, that is, 0.05 % toluidine blue indicator solution)
操作步骤： Operation steps: 将试验样品置于23±2℃、相对湿度50±2%的环境下放置24小时。向包装内注入足够的染色液，使能覆盖包装的最长边，深约5mm，让染色液与密封边保持接触最短5S，最长20S。观察染料渗透情况。 Place the test sample in an environment of 23 ± 2 ℃ and relative humidity of 50 ± 2% for 24 hours. Inject enough dyeing liquid into the package to cover the longest side of the package, about 5mm deep, and keep the dyeing liquid in contact with the sealing edge for a minimum of 5S and a maximum of 20S . Observe the dye penetration.
检验结果： Test results:
序号 serial number		渗漏情况 Leakage	序号 serial number		渗漏情况 Leakage
1			16
2			17
3			18
4			19
5			20
6			21
7			22
8			23
9			24
10			25
11			26
12			27
13			28
14			29
15			30

检验结论：□符合规定 □不符合规定
Inspection conclusion: □ Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（微生物屏障） Original record of catheter quality inspection (microbial barrier)
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.15 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.15

仪器 instrument
名称 name	编号 serial number	备注 Remark
超净工作台 Ultra clean workbench
生物安全柜 biological safety cabinet
生化培养箱 Biochemical incubator

操作步骤：
Operation steps:

在温度为23℃，相对湿度为50%的实验室中进行调节24h。
Adjust for 24 hours in a laboratory with a temperature of 23 °C and a relative humidity of 50% .

在无菌操作下，把处理好的样品（5*5cm已灭菌），用灭菌镊子夹至一次性空平皿中，可能受污染的一面朝上；
Under aseptic operation, use sterilized tweezers to clamp the processed sample ( 5*5cm sterilized) into a disposable empty plate , with the potentially contaminated side facing up;

制作金黄色葡萄球菌菌悬液：用一次性接种环从工作菌株平板中挑取一个菌落，然后加入到新鲜灭好菌的营养肉汤管中，搅拌，放置37℃培养箱培养24h；第二天取出，然后逐步稀释7个浓度，每个浓度各取1ml的稀释液放入无菌培养皿中，加入灭菌好的溶化的营养琼脂混合。
Make Staphylococcus aureus suspension: Use a disposable inoculation loop to pick a colony from the working strain plate, then add it to a freshly sterilized nutrient broth tube, stir , and place it in a 37 °C incubator for 24 hours ; Section 2 Take it out two days later, and then gradually dilute it into 7 concentrations. Take 1 ml of the dilution solution for each concentration and put it into a sterile petri dish. Add sterilized dissolved nutrient agar and mix.

用1:100的稀释物3中，取5滴，每滴0.1ml，滴加到每个试验样品的上表面，每滴不互相接触，盖好平皿盖，在生物安全柜中放置16h，使液滴我完全干燥。
Use 1:100 dilution 3 , take 5 drops, each drop is 0.1ml , and add it to the upper surface of each test sample. Each drop should not contact each other. Cover the plate and place it in a biological safety cabinet for 16 hours . Let the droplets dry completely.

在无菌操作下，把4中制得的每个样品当值在一个血平板的表面上，接种面朝上，以整个实验面与血琼脂接触，用灭菌L棒轻轻抹平，接触5—6S后除去试验样品，把血平板放置37℃培养箱培养24h，观察结果。
Under aseptic operation, place each sample prepared in step 4 on the surface of a blood plate, with the inoculated side facing up, with the entire experimental surface in contact with the blood agar, and gently smooth it with a sterilized L stick. After 5 to 6 seconds , remove the test sample, place the blood plate in a 37 °C incubator for 24 hours , and observe the results.

阳性对照：试验步骤与试验组一致，区别就是，用试验样品的接种面与血平板进行表面接触，经过37℃，24h培养后，平板上应长菌明显；
Positive control: The test procedure is the same as that of the test group. The difference is that the inoculated surface of the test sample is in surface contact with the blood plate. After 24 hours of incubation at 37 °C , bacteria should be evident on the plate ;

阴性对照：用不接种任何菌悬液的样品直接与血平板的表面进行接触，在培养结束时，血平板上应无菌生产。
Negative control: Use a sample without inoculation of any bacterial suspension to directly contact the surface of the blood plate. At the end of the culture, the blood plate should be sterile.

营养肉汤配制日期： Nutrient broth preparation date :		培养温度： Culture temperature:
生理盐水配制日期： Normal saline preparation date :		培养温度： Culture temperature:
营养琼脂培养基配制日期： Nutrient agar medium preparation date :		培养温度： Culture temperature:
血平板： Blood plate:		培养温度： Culture temperature:
金黄色葡萄球菌菌浓度： Staphylococcus aureus concentration:

检验结果：
Test results:

样品号 Sample number	血平板上的金黄色葡萄球菌菌落数（cfu/皿） Staphylococcus aureus colony count on blood plate ( cfu / dish )	样品号 Sample number	血平板上的金黄色葡萄球菌菌落数（cfu/皿） Staphylococcus aureus colony count on blood plate ( cfu / dish )	样品号样品号 sample number sample number	阴性对照阴性对照 negative control negative control
					-









					阳性对照 positive control
					阳性对照 positive control

注：零生长可以用“-”，不可计可以用“+”表示，如平板有可数菌落数则如实记录数据。
Note: Zero growth can be expressed by " - ", and uncountable growth can be expressed by " + ". If there are countable colonies on the plate, record the data truthfully.

检验结论：□符合规定 □不符合规定
Inspection conclusion: □ Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（气泡试验） Original record of catheter quality inspection ( bubble test )
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.16 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.16

环境条件： Environmental conditions:	温度：湿度：大气压： Temperature: Humidity: Atmospheric pressure:
包装类型 Packaging type	吸塑盒+透析纸 Blister box + dialysis paper		包装材料 packaging materials	PETG和特卫强 PETG and Tyvek
试验最小压力 Test minimum pressure	17.76Kpa
实验步骤 Experimental steps	对照组： Control group: 取1个样品作为对照样品，用不大于250μm针尖在对照样品制造一个已知的缺陷，并在缺陷周围画圈标记。 Take one sample as a control sample, use a needle tip no larger than 250 μm to create a known defect in the control sample, and draw a circle mark around the defect. 将对照样品浸入水下约25mm深处，至少保持5秒，然后向对照样品内充气。 Immerse the control sample approximately 25mm underwater for at least 5 seconds and then inflate the control sample. 调整气流，使对照样本逐渐膨胀，知道缺陷点冒出气泡； Adjust the airflow to gradually expand the control sample until bubbles appear at the defective points; 记录冒出气泡的压力，即为最小试验压力。 Record the pressure at which bubbles appear, which is the minimum test pressure. 实验组： Experimental group: 按上述1、2、3步骤完成测试，测试时间为1min Complete the test according to steps 1 , 2 , and 3 above . The test time is 1 minute.
检验结果： Test results:
样品号 Sample number	泄露情况 Leakage	泄露位置 leak location	样品号 Sample number	泄露情况 Leakage	泄露位置 leak location
1			16
2			17
3			18
4			19
5			20
6			21
7			22
8			23
9			24
10			25
11			26
12			27
13			28
14			29
15			对照组 control group

注：“+”表示包装有泄露，“-”表示包装无泄露
Note: " + " means there is leakage in the package, " - " means there is no leakage in the package

检验结论：□符合规定 □不符合规定
Inspection conclusion: □ Conforms to regulations □Does not comply with regulations

检验人：复核人：
Inspector: Reviewer:

日期：日期：
Date : Date :

导管质量检验原始记录（剥离强度） Original record of catheter quality inspection ( peel strength )
样品名称 Sample name		取样量 Sampling volume
批号 batch number		检验日期 Inspection date
检验依据 Inspection basis	《肾动脉射频消融导管货架有效期方案GL-YF-RDN-JG-019》7.16 "Renal artery radiofrequency ablation catheter shelf life protocol GL-YF-RDN-JG-019 " 7.16

试样制备：使用裁刀在每只灭菌包装封口4边各裁取一段宽度为15mm、长度约70mm~100mm的试条，裁剪时裁剪方向与密封边方向成90°±5°。
Sample preparation: Use a cutter to cut a test strip with a width of 1.5 mm and a length of about 7.0 mm ~ 100 mm on each of the four sides of the seal of each sterilization package. When cutting, the cutting direction is 90 ° with the direction of the sealing edge . ± 5 °.

设备及仪器
Equipment and instruments

仪器 instrument
名称 name	编号 serial number	其它 other
智能电子拉力实验机 Intelligent electronic tensile testing machine
直尺 ruler

结果
result

样品序号 Sample serial number	F1（N） F1 ( N )	F2（N） F2 ( N )	F3（N） F3 ( N )	F4（N） F4 ( N )	平均剥离力(N) Average peeling force (N)	平均剥离强度kN/m Average peel strength kN /m
1
2
3
4
5
6
7
8
9
10
判定标准 Judgment criteria	试样密封边的剥离强度应大于0.08kN/m（1.20N/15mm） The peel strength of the sealing edge of the sample should be greater than 0.08 k N / m (1.20N /15 mm)

检验结论：□符合规定 □不符合规定
Inspection conclusion: □Conforms to regulations □Does not comply with regulations

检验人：复核人：