【讨论】 EN 1422-1998 附录A

我是不懂药典，简单看了下楼主的翻译，有几个疑问
informative 提示的附录 感觉有点别扭。 是不是说这个附录只是信息性的，而不是强制性的？

建议的水蒸气污染物的最大值 我觉得把“建议的”换个位置，水蒸气污染物的推荐最大值

表A.1 重金属一项，欧洲药典可以不用写出吧，后面已经有EP两个字母了，就知道是欧洲药典了

an can invalidate the manufacturer's warranty or guarantee。楼主翻译是： 同时使得制造商的质保资格丧失了
我觉得这里不是说制造商的质保资格丧失，而是如果用户不采用这个附录中制造商所建议的限值，那么制造商的保证将会失效，也就是说制造商不再对因此引起的灭菌器使用问题负责。
compliance 这个应该是验证性试验吧，楼主好像漏了验证两个字

limite test 限度方法？ 我一般都觉得是极限试验，也许是一个意思吧
standard solution 楼主翻译为标准对照液 我一般都是些标准溶液

reference solution控制溶液....参照溶液。

EN 1422-1998 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Annex A (informative)
Suggested maximum values of steam contaminants
Table A.1 — Contaminants in condensate and feed water

EN 1422医用灭菌器 — 环氧乙烷灭菌器 — 要求和检验方法
附录A（提示的附录）
建议的水蒸汽污染物的最大值
表A.1 — 冷凝水和锅炉水的污染物

我把楼主的翻译和原文贴出来，方便大家对照着看

1) European Pharmacopoeia (EP), Monograph 8, Purified Water, Test method V.3.2.8
NOTE 1 The use of feedwater or steam with contaminants at levels exceeding those given above can greatly shorten the working life of a sterilizer and can invalidate the manufacturer’s warranty or guarantee.
NOTE 2 Compliance should be tested in accordance with acknowledged analytical methods.

1) 欧洲药典（EP），专论8，纯化水，试验方法V.3.2.8
注1 使用污染物超过上述给出的限度的锅炉水或水蒸汽将大大缩短灭菌柜的工作寿命，同时使得制造商的质保资格丧失。
注2 应按照公认的分析方法进行试验。

Heavy metals (2.4.8): maximum 0.1 ppm.
Heat 200 ml in a glass evaporating dish on a water-bath until the volume is reduced to 20 ml. 12 ml of the concentrated solution complies with limit test A. Prepare the standard using 10 ml of lead standard solution (1 pprn Pb) R.

2.4.8. HEAVY METALS
The methods described below require the use of thioacetamide reagent R. Asanalternative, sodium sulphide solution R1 (0.1 ml) is usually suitable. Since tests prescribed in monographs have been developed using thioacetamide reagent R,if sodium sulphide solution R1 is used instead, it is necessary to include also for methods A and B a monitor solution, prepared from the quantity of
the substance to be examined prescribed for the test, to which has been added the volume of lead standard solution prescribed for preparation of the reference solution. The test is invalid if the monitor solution is not comparable with the reference solution.



重金属（2.4.8）：不超过0.1 ppm。
取本品200 ml置玻璃蒸发皿中，于水浴加热直至剩下20 ml作为供试品水溶液。取12 ml该浓度的溶液按照限度方法A进行试验。用10 ml的铅标准溶液R（1 ppm Pb）制备标准对照液。
2.4.8重金属
下述方法中所用到的硫代乙酰胺试液R，通常也可以用硫化钠溶液R1(0.1ml)代替。各论中规定使用硫代乙酰胺试液，因此若要改用硫化钠溶液，无论是方法A还是方法B都应制备控制溶液。控制溶液的制法：取规定量的供试品，加入制备对照溶液所需（体积）的铅标准溶液。若无法比较控制溶液与对照溶液的颜色，则检验无效。

METHOD A
Test solution. 12 ml of the prescribed aqueous solution of the substance to be examined.
Reference solution (standard). A mixture of 10 ml of lead standard solution (1 ppm Pb) R or lead standard solution (2 ppm Pb) R, as prescribed, and 2 ml of the prescribed aqueous solution of the substance to be examined.
Blank solution. A mixture of 10ml of water R and 2 ml of the prescribed aqueous solution of the substance to be examined.
To each solution, add 2 ml of buffer solution pH 3.5 R.Mix. Add 1.2 ml of thioacetamide reagent R. Mix immediately. Examine the solutions after 2 min. The test is invalid if the reference solution does not show a slight brown colour compared to the blank solution. The substance to be examined complies with the test if any brown colour in the test solution is not more intense than that in the reference solution.
If the result is difficult to judge, filter the solutions through a membrane filter (pore size 3 μm; see Figure 2.4.8.-1, without the prefilter). Carry out the filtration slowly and uniformly, applying moderate and constant pressure to the piston. Compare the spots on the filters obtained with the different solutions.
方法A
供试液：取规定的供试品水溶液12 ml。
标准对照液：取规定的铅标准溶液（1 ppm Pb）或（2 ppm Pb）10 ml，再加入规定的供试品水溶液2 ml，混匀。
空白液：取实验用水10 ml，再加入规定的供试品水溶液2 ml，混匀。
于上述溶液中分别加入pH3.5的缓冲液2 ml。混匀。再加入硫代乙酰胺试液1.2 ml，立即混匀。2 min后进行观察。标准对照液与空白液比较显浅棕色，试验有效。供试品同法试验，观察供试液显现的棕色是否不深于标准对照液。
若结果难以判定，将供试品溶液用孔径3 μm的微孔滤膜过滤，见2.4.8.-1，不需要初滤器。过滤要求缓慢、均一，过滤时的速度和压力保持不变，比较不同种溶液在滤膜过滤后的色斑的颜色深浅。

非常同意您的意见！第一次翻译，有些自己也不是很明了。谢谢！