喜报!北检润和喜获检测和计量领域CNAS新资

 

2025年3月10日,北检润和(北京)技术服务有限公司喜获检测和计量领域CNAS新参数的资质。本次CNAS资质覆盖的检测领域有模拟运输和包装性能验证,涉及的主要标准和参数如下表所示:

序号

名称

标准 / 规范条款

1

Handling—Manual and Mechanical
人工搬运

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

2

Warehouse Stacking
仓库堆码

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

3

Vehicle Stacking
车辆堆码

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

4

Stacked Vibration
随机振动

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

5

Vehicle Vibration
车载振动

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

6

Loose Load Vibration
松散振动

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

7

Low Pressure (High Altitude) Hazard
低气压

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

8

Concentrated Impact
集中冲击

ASTM D4169-23e1
Standard Practice for Performance Testing of Shipping Containers and Systems

9

Seal Strength
密封强度

ASTM F88/F88M- 23
Standard Test Method for Seal Strength of Flexible Barrier Materials

10

Burst Test
胀破试验

ASTM  F1140/F1140M-13(2020)e1
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

11

Creep Test
蠕变试验

ASTM  F1140/F1140M-13(2020)e1
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

12

Creep to Failure
蠕变至破坏

ASTM  F1140/F1140M-13(2020)e1
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

13

Seal Leaks
密封泄漏

ASTM F1929-23
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging
by Dye Penetration

14

Leaks in Flexible Packaging
目力检测

ASTM D3078-02(2021)e1
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

15

Integrity of Seals
真空泄漏

ASTM F1886/F1886M-16(2024)
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

16

Gross Leaks in Packaging
粗大泄漏

ASTM F2096-11(2019)
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

本次增项在之前满足医疗器械产品国内注册需求的基础上,可以同时满足FDA、CE等国际注册过程中运输可靠性和包装性能验证的需求。

另外,本次CNAS资质增加了计量领域的参数,可满足医疗器械生产企业配备的干燥箱、培养箱、恒温箱、水浴和压差表的计量校准。涉及的主要标准和参数如下表所示:

序号

测量仪器名称

校准规范

1

机械式温湿度计

机械式温湿度计检定规程J.JG205

2

数字式温湿度计/温湿度传感器/温湿度记录仪

数字式温湿度计校准规范JJF1076

3

医用热力灭菌设备温度计

医用热力灭菌设备温度计校准规范 JJF1308

4

环境试验设备

环境试验设备温度、湿度参数校准规范 JJF1101

5

箱式电阻炉

箱式电阻炉校准规范JJF1376

6

液体恒温浴

液体恒温试验设备温度性能测试规范 JJF2019

7

灭菌器

小型压力蒸汽灭菌器温度、压力参数校准规范 JJF(京)141

 

8

微压差表

微压差表校准规范JJF(京)63

9

弹性元件式精密压力表和真空表

弹性元件式精密压力表和真空表检定规程 JJG 49

10

弹性元件式一般压力表、压力真空表和真空表

弹性元件式一般压力表、压力真空表和真空表检定规程 JJG 52

11

数字压力计

数字压力计检定规程JJG875

本次CNAS扩项的计量参数虽然不多,但是可以满足医疗器械生产企业大部分生产、检验设备的计量需求,为拓展计量领域业务开拓了新的途径。

在此,公司诚挚邀请各界朋友莅临参观指导,共同见证我们的成长与发展。我们坚信,在未来的道路上,北检润和将以更高的品质、更专业的态度服务于每一位客户,共同开创更加辉煌的明天!

 

联系我们:

战女士

手机/微信:18614047679

邮箱:zhanbin@rheinhealthcare.com

李女士

手机/微信:18510967167

邮箱:lijing@rheinhealthcare.com

创建时间:2025-03-21 16:55
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