加入收藏 在线留言 联系我们
关注微信
手机扫一扫 立刻联系商家
罗工17324413130

美国纺织品面料标准 ASTM F 2100 医用面罩用材料性能规格测试

更新时间
2024-11-13 20:00:00
价格
请来电询价
测试周期
5-7天
寄样地址
深圳宝安
价格费用
电话详谈
联系电话
17324413130
联系手机
17324413130
联系人
罗卓文
立即询价

详细介绍


 

Test item 测试名称: 医用面罩用材料性能规格 Mask Performance Rating 

 

Test info 测试内容:


Bacterial Filtration Efficiency (BFE) only 细菌过滤效率 , EN 14683 Annex B, ASTM F 2101, 15pcs (无菌样品)
Differential pressure only , Delta P , 气压差, ASTM F 2100, 10pcs
Particle Filtration Efficiency,PFE: Latex particle challenge 乳胶颗粒过滤效率, ASTM F 2299, 15pcs
ASTM F 1862 Synthetic blood fluid penetration resistance for face masks 血液穿透阻力+ 防溅阻力, ASTM F 1862, 40pcs
16 CFR Part 1610  Flammability test 阻燃, 20pcs






 

Lead Time 测试周期: 12 working days

Sample size 送样规格: 70pcs

FDA更新抽样要求

It has recently come to our attention that 5 samples for Bacterial Filtration Efficiency (BFE), Differential Pressure (Delta P), and Particle Filtration Efficiency (PFE) may no longer be adequate for FDA submissions. In the past, many manufacturers tested a minimum of 5 samples for Delta P, BFE, and PFE and historically this amount has been successful in getting submissions approved through FDA. But with recent information we have received from FDA and multiple sponsors, is it clear that FDA is enforcing requirements for sampling as stated in the ASTM F 2100 standard as listed below:

           
7. Sampling

7.1 Testing shall be performed on materials taken from manufactured face masks.

7.2 An acceptable quality limit of 4% shall be used for all required testing to establish conformance of medical face masks to a specific performance class.

7.3 Examples of acceptable sampling plans are found in ANSI/ASQC Z1.4 and ISO2859-1.

   
 8. Number of Tests

8.1 A sufficient number of medical face mask shall be evaluated for each test to achieve the established acceptable quality limit or confidence level.

Beyond the ASTM F2100 specification, FDA has also been asking manufactures to test up to three non-consecutive lots to demonstrate lot-to-lot performance or justify why this was not performed. For FDA submissions, we recommend you take the most conservative route to prevent any delays in your submission. The table below is our current recommendation based on recent trends:

Test

Standard

Sample amount per lot

# of lots

Total

Synthetic Blood

ASTM F1862

(specifies 32)

32

3

96

Flammability

16 CFR Part 1610

(specifies 14)

14 (4 preliminary, 5 preliminary classification, 5 if necessary, based on burn time) FDA is requiring 32 samples

3

100

BFE

ASTM F2101

(no sample amount specified)

AQL 4%, FDA will accept 32

3

96

Delta P

EN 14683

(no sample amount specified)

AQL 4% FDA will accept 32

3

96

PFE

ASTM F2299

(no sample amount specified)

AQL 4% FDA will accept 32

3

96


Five samples may be sufficient for periodic R&D or verification testing but is not recommended for FDA submission. 



Others 其他信息:

 

Photo for reference 参考图片:

 Responsive image

  

Sample Report 报告样本:

Responsive image
Responsive image
Responsive image
Responsive image

Responsive image
Responsive image
Responsive image
Responsive image
Responsive image
Responsive image

 Responsive image  Responsive image  Responsive image
Responsive imageResponsive image







相关产品

联系方式

  • 电  话:17324413130
  • 检测工程师:罗卓文
  • 手  机:17324413130