18/30355036 DC - BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

18/30355036 DC

BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

Status : Current, Draft for public comment   Published : August 2018

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Standard Number18/30355036 DC
TitleBS EN ISO 10993-7 AMD1. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
StatusCurrent, Draft for public comment
Publication Date16 August 2018
Normative References(Required to achieve compliance to this standard)ISO 10993-1:2018
Informative References(Provided for Information)ASTM E691 - 18, ISO 11135:2014, AAMI GVR:1987
International RelationshipsISO 10993-7:2008/Amd 1,ISO 10993-7:2008/DAmd 1:2018
Draft Expiry Date01 October 2018
DescriptorsExtraction methods of analysis, Temperature, Solvent extraction methods, Medical equipment, Testing conditions, Dose (drug), Determination of content, Precision, Standard solutions, Chemical analysis and testing, Formulae (mathematics), Aqueous extraction methods, Factor of safety, Biological analysis and testing, Gas chromatography, Sampling methods, Safety measures, Conformity, Chemical hazards, Biological hazards, Calibration, Sterilization (hygiene), Sterile equipment, Ethylene oxide
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation à l'oxyde d'éthylène AMENDEMENT 1
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages14
File Size382 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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