Sterility assurance level

Results: 25



#Item
11Technology / Medical equipment / Food law / Medical device / Medical technology / Sterilization / Sterility assurance level / Center for Devices and Radiological Health / Validation / Medicine / Health / Food and Drug Administration

PDF Document

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Source URL: www.fda.gov

Language: English - Date: 2003-03-10 15:51:55
12Microbiology / Hygiene / Electron beam / Sterilization / Autoclave / ETO / Sterility assurance level / Anthrax / Sterility / Health / Medicine / Biology

Technology Information Summary: EOGas Sterilization Systems

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Source URL: epa.gov

Language: English - Date: 2011-11-21 14:38:43
13Technology / Business / Electron beam / Microbiology / Sterilization / Validation / Packaging and labeling / Sterility assurance level / Science / Pharmaceutical industry / Hygiene / Validity

Microsoft Word - MicroQBR-TS-SA-QOS Outline-29Sept2011.doc

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Source URL: www.fda.gov

Language: English
14Health / Electron beam / Hygiene / Microbiology / Sterilization / Medical equipment / Autoclave / Sterility assurance level / Bacillus stearothermophilus / Biology / Medicine / Laboratory equipment

Steam sterilization validation of Smith & Nephew orthopaedic instrument sets in reusable rigid container systems Introduction

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Source URL: www.smith-nephew.com

Language: English - Date: 2013-08-19 14:32:49
15Hygiene / Validity / Food safety / Technology / Radiobiology / Validation / Sterilization / Verification and validation / Sterility assurance level / Pharmaceutical industry / Medicine / Health

Untitled Document This content was archived on June 24, 2013. Archived Content Information identified as archived on the Web is for reference, research or recordkeeping purposes. It

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-07-09 10:25:48
16Microbiology / Hygiene / Electron beam / Sterilization / Autoclave / ETO / Sterility assurance level / Anthrax / Sterility / Health / Medicine / Biology

Technology Information Summary: EOGas Sterilization Systems

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Source URL: www.epa.gov

Language: English - Date: 2011-11-21 14:38:43
17Hygiene / Health / Electron beam / Microbiology / Sterilization / Sterility assurance level / Ethylene oxide / Validation / Ethylene glycol / Chemistry / Medicine / Monomers

ORDB 510(K) STERILITY REVIEW GUIDANCE[removed]For STERILE devices: 1. Provide the sterilization method that will be used or was used [radiation, steam, EtO].

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Source URL: www.fda.gov

Language: English
18Hygiene / Electron beam / Microbiology / Sterilization / Pharmaceutical industry / Sterility assurance level / Medical device / Center for Devices and Radiological Health / Dry heat sterilization / Medicine / Health / Food and Drug Administration

Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA

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Source URL: www.fda.gov

Language: English
19Pharmaceutical industry / Pharmaceuticals policy / Hygiene / Clinical research / Medical device / Sterilization / Center for Devices and Radiological Health / Premarket approval / Sterility assurance level / Medicine / Health / Food and Drug Administration

Concept Paper for CDRH Guidance Documents

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Source URL: www.fda.gov

Language: English
20Hygiene / Electron beam / Microbiology / Sterilization / Pharmaceutical industry / Sterility assurance level / Medical device / Center for Devices and Radiological Health / Dry heat sterilization / Medicine / Health / Food and Drug Administration

Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA

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Source URL: www.fda.gov

Language: English
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