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FDA 21 CFR Part 801.410返回 Back

Test item 测试名称: Lens Impact 镜片撞击 ( 镜落测试 )

Norm refer 涉及标准: ISO 21311, EN 1836, ANSI Z 80.3, QB2457, GB 10810.3

Test info 测试内容:

Impact Resistance Test (Applicable for Sunglasses Lens Only)

Under 21 CFR 801.410©(3), it is required to test a statistically significant sample of over-the-counter glasses lenses

from each production batch. And FDA accepts the Acceptabel Quality Level (AQL) of 6.5,

General Inspection Level II.

測試樣品數量要求對照表(Test samle size for Pairs of Sunglasses)

出貨批次量

測試樣品需求

(單位: pairs)

(單位:pairs)

2 to 8

2

9 to 15

3

16 - 26

5

26 - 50

8

51 - 90

13

91 - 150

20

151 - 280

32

281 - 500

50

501 - 1200

80

1201 - 3200

125

3201 - 以上

200

Lead time 测试周期: 常规 regular 10 working days

Sample size 送样规格:

different sample size different cost

0 - 50 lenses

51 - 80 lenses

81 - 125 lenses

126 - 200 lenses

over 200 lense

Sample for reference 参考图片:

Sample Report 报告样本：

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Under 21 CFR 801.410©(3), it is required to test a statistically significant sample of over-the-counter glasses lenses
from each production batch. And FDA accepts the Acceptabel Quality Level (AQL) of 6.5,
General Inspection Level II.

測試樣品數量要求對照表(Test samle size for Pairs of Sunglasses)
出貨批次量	測試樣品需求
(單位: pairs)	(單位:pairs)
2 to 8	2
9 to 15	3
16 - 26	5
26 - 50	8
51 - 90	13
91 - 150	20
151 - 280	32
281 - 500	50
501 - 1200	80
1201 - 3200	125
3201 - 以上	200