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

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BS EN ISO 10993-1:October 2009

Biological evaluation of medical devices. Evaluation and testing within a risk management process

Status : Current   Published : June 2010

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What is BS EN ISO 10993-1:October 2009?

The main objective of BS EN ISO 10993-1 is to protect people from potential biological hazards that could arise from the use of medical instruments or medical technology. The standard contains a variety of guidelines that relate to the biological analysis and testing of medical devices, such as dental equipment and surgical implants. It has been compiled to test medical instruments within a risk management process – as part of the overall evaluation and development of each device.

How does it work?

The general principles set out in BS EN ISO 10993 were developed to help organisations or individuals to do a biological evaluation of medical equipment within a risk management process. The standard looks at the general classification of devices based on their nature and duration of contact with the body. It also explains the evaluation of existing and relevant data from all sources, before identifying information gaps. BS EN ISO 10993 also shares best practice recommendations to do a full assessment of the biological safety of medical instruments.

Who should buy it?

  • Anyone responsible for the biological evaluation of medical equipment
  • Manufacturers of medical instruments, dental equipment and implants
  • Suppliers of medical equipment
  • Inspectors
  • Risk assessors

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Standard NumberBS EN ISO 10993-1:October 2009
TitleBiological evaluation of medical devices. Evaluation and testing within a risk management process
StatusCurrent
Publication Date30 June 2010
Cross ReferencesISO 10993-2, ISO 10993-3, ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-7, ISO 10993-9, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-13, ISO 10993-14, ISO 10993-15, ISO 10993-16, ISO 10993-17, ISO 10993-18:2005, ISO/TS 10993-19, ISO/TS 10993-20, ISO 14971, ISO 7405, ISO 9000, ISO 9001, ISO 9004, ISO 13485, ISO/IEC 17025, 93/42/EEC, 90/385/EEC
ReplacesBS EN ISO 10993-1:2009, Replaces BS EN ISO 10993-1:2009 which is the implementation of EN ISO 10993-1:2009 June edition.
International RelationshipsEN ISO 10993-1:2009 Identical, ISO 10993-1:2009 Identical
Amended ByCorrigendum July 2010. Corrigendum November 2010.
DescriptorsMedical equipment, Biological analysis and testing, Medical instruments, Medical technology, Biological hazards, Dental equipment, Dental materials, Implants (surgical), Clinical investigation instruments, Bioassay, Cytotoxicity tests, Contaminants, Compatibility
ICS11.100.20 (Biological evaluation of medical devices)
Title in FrenchÉvaluation biologique des dispositifs médicaux. Évaluation et essais au sein d'un processus de gestion du risque
Title in GermanBiologische Beurteilung von Medizinprodukten. Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems
CommitteeCH/194
ISBN978 0 580 71636 2
PublisherBSI
FormatA4
DeliveryYES
Pages32
File Size1.666 MB
NotesImplements EN ISO 10993-1:2009, October edition.
Price£ 140.00


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