piery2006
第12楼2009/06/01
这个很简单EN 71-9,10,11应该放在一起来读.
关于最大限量要求:
4.1 Limits (see A.4)
4.1.1 Table 1 specifies toys, toy components and toy materials for which this document contains
requirements. An “X” is indicated in columns 2A – 2I when requirements are given in the limit Tables 2 A – 2 I
for certain groups of organic chemicals. The toys and accessible toy components specified in Table 1 shall
not contain or release the organic compounds in the relevant limit tables in amounts which exceed the limits
specified.
关于处置限值:
If a limit specified in a limit table is expressed as “Action limit”, the relevant limit shall be the limit of the
applicable method as specified in prEN 71-11.
关于表2B的颜料说明:
A.10 Limit tables (see Tables 2 A to 2 I)
The limit tables contain some limits expressed in absolute terms and some expressed as “action limit”.
In general, the absolute limits are either adapted from requirements for other consumer products or calculated
from toxicological data concerning the organic compound and exposure models specifically designed for the
purposes of this document. The absolute limits, therefore, should not be used to assess products other than
the toys for which they are specified in this document. In setting and calculating the limits, only the exposure
from toys has been considered and exposure from other products will differ considerably depending on those
products and their uses.
The limits expressed as “action limits” apply to those organic compounds that have been identified as those
which should not be used in toys or which it would be inappropriate to find above that limit in toys. These
compounds should therefore not be detected in toys or migration media, and the limits are effectively the limits
of quantification of the appropriate methods described in prEN 71-11.
看过A.10的补充说明之后,可能印象会更深刻一些.
其实A.10中已经说得很清楚了.
6404795
第14楼2009/06/23
你的理解完全正确!O(∩_∩)O哈哈~
poorlittle
第16楼2009/07/17
Just incidentally found the following from the section of “微生物检查” edited by happyjyl in http://www.instrument.com.cn/bbs/shtml/20060703/473904/ , but I am not sure whether it is relevant to the subject discussed.
action limit 纠偏限度。是微生物污染的某一限度。监控结果超过此限度时,表明系统已偏离正常的运行条件,需立即采取纠偏措施,使系统回到正常的运行状态。目前,欧美药典均设立了注射用水(包括纯化水)的警戒水平和纠偏限度的监控措施,其目的是建立各种规程,以便当监控结果显示某种超标风险时,可实施这些规程,从而确保制水系统始终达标运行,生产出合格的水。USP微生物纠偏限度的要求:饮用水不超过500cfu/ml,纯化水不超过100cfu/ml,注射用水不超过10cfu/100ml。