18/30338923 DC - BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

18/30338923 DC

BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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

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Standard Number18/30338923 DC
TitleBS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
StatusCurrent, Draft for public comment
Publication Date14 June 2018
Normative References(Required to achieve compliance to this standard)ISO 15189:2012, ISO/IEC 17025:2017, ISO 11737-1:2018, ISO 13485:2016, ISO 10012
Informative References(Provided for Information)ISO 17665-1, ISO 11137-1, ISO 11139:201X, ISO 14160, ISO 11138-7, ISO 14644-1, ISO 14644-7, ISO 20857, ISO 11138-2, ISO 14937, ISO 11135, ISO 11137-2, ISO 14644-4, ISO 9000:2015, ISO/IEC 90003:2014, EN ISO 9001:2015
International RelationshipsENISO 11737-2
Draft Expiry Date31 July 2018
DescriptorsSamples, Microbiology, Assessed reliability, Specimen preparation, Process control, Sterile equipment, Sterilization (hygiene), Test equipment, Approval testing, Microbiological analysis, Biological analysis and testing, Medical equipment
ICS07.100.10
11.080.01
CommitteeCH/198
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size461 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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