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MedicalDevice版 - Any good book or website for sterilization and packaging?
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进入MedicalDevice版参与讨论
1 (共1页)
b***p
发帖数: 1398
1
thanks
s**********8
发帖数: 25265
2
amazon上search

【在 b***p 的大作中提到】
: thanks
p*********g
发帖数: 22025
3
Google上search
ot
发帖数: 4549
4
controlled environment is a free magazine you can subscribe to.
If you have USP, it has many sections/chapters pertain to sterilization
If you want to spend a month on in-depth reading, here is a list
ISO 11134
ISO 11135,
ISO 11137,
ISO 11138,
ISO 10993-7
ISO 11607
ISO 11737
Parenteral Drug Association. 1978. Validation of steam sterilization cycles.
Technical report 1. Parenteral Drug Association, Bethesda, Md.
Pearson, F. 1985. Pyrogens, endotoxins, LAL testing, and depyrogenation.
Marcel Dekker, New York, N.Y.
United States Pharmacopeial Convention. Chapters 51, 61, 71, 85, 1035, 1111,
1116, 1208, 1211, 1227, and 1231. In United States
Pharmacopeia and National Formulary. United States Pharmacopeial Convention,
Rockville, Md.
U.S. Food and Drug Administration. 1995. Microbiological methods for
cosmetics. In Bacteriological analytical manual (BAM), 8th ed. AOAC
International, Arlington, Va.
Internet
USP. http://www.usp.org
AAMI. http://www.cssinfo.com/info/aami.html
AOAC International. http://www.aoac.org
APHA. http://www.apha.org
CFR. http://www.access.gpo.gov/nara/cfr
FDA-BAM. http://www.cfsan.fda.gov/~ebam/bam-toc.html

【在 b***p 的大作中提到】
: thanks
s**********8
发帖数: 25265
5
感谢ot thoughtful input!!

【在 ot 的大作中提到】
: controlled environment is a free magazine you can subscribe to.
: If you have USP, it has many sections/chapters pertain to sterilization
: If you want to spend a month on in-depth reading, here is a list
: ISO 11134
: ISO 11135,
: ISO 11137,
: ISO 11138,
: ISO 10993-7
: ISO 11607
: ISO 11737

ot
发帖数: 4549
6
哈哈,这个都是现成的。其实american microbiology society 有一个消毒杀菌方面的
证书,去考一下就都学到了。

【在 s**********8 的大作中提到】
: 感谢ot thoughtful input!!
s**********8
发帖数: 25265
7
贴也要废功夫不是?

【在 ot 的大作中提到】
: 哈哈,这个都是现成的。其实american microbiology society 有一个消毒杀菌方面的
: 证书,去考一下就都学到了。

b***p
发帖数: 1398
8
give 10 to ot形象

【在 ot 的大作中提到】
: controlled environment is a free magazine you can subscribe to.
: If you have USP, it has many sections/chapters pertain to sterilization
: If you want to spend a month on in-depth reading, here is a list
: ISO 11134
: ISO 11135,
: ISO 11137,
: ISO 11138,
: ISO 10993-7
: ISO 11607
: ISO 11737

1 (共1页)
进入MedicalDevice版参与讨论
相关主题
help on 源材料的问题学术第一贴 - 美国器械分类.
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终于有一个想的开的政府了美国进口医疗器械程序: basics
Combination Product俺也来帮斑竹添砖---IDE (investigational device exempt)
ISO 13485Humanitarian Use Devices (HUD)
找工作(2年经验)FDA Regulation of Medical Devices
什么样的医疗器械是国内没得的sterilization: 器械灭菌
相关话题的讨论汇总
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