17/30344601 DC - BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process

17/30344601 DC

BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process

Status : Current, Draft for public comment   Published : February 2017

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PDF

Format
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Standard Number17/30344601 DC
TitleBS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
StatusCurrent, Draft for public comment
Publication Date20 February 2017
Normative References(Required to achieve compliance to this standard)ISO 10993-4:2017, ISO 10993-7, ISO 10993-5, ISO 10993-18, ISO/TS 10993-19, ISO 14971, ISO 10993-2, ISO 10993-10, ISO 10993-15, ISO 10993-6, ISO/TS 10993-20, ISO/TR 10993-22, ISO 10993-12, ISO 10993-17, ISO 10993-14, ISO 10993-16, ISO 10993-9, ISO 10993-3, ISO 10993-11, ISO 10993-13
Informative References(Provided for Information)90/385/EEC, ISO/IEC 17025, ISO 9000, ISO 9004, ISO 9001, 93/42/EEC, ISO 18562, ISO/TR 10993-33, ISO 13485:2003, ISO 7405
International RelationshipsISO 10993-1,ENISO 10993-1
Draft Expiry Date14 April 2017
DescriptorsBioassay, Cytotoxicity tests, Clinical investigation instruments, Contaminants, Medical instruments, Dental materials, Compatibility, Medical equipment, Implants (surgical), Dental equipment, Medical technology, Biological hazards, Biological analysis and testing
ICS11.100.20
CommitteeCH/194
PublisherBSI
FormatA4
DeliveryYes
Pages53
File Size1.154 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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