BS EN ISO 18113-3:2011 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use

BS EN ISO 18113-3:2011

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use

Status : Current   Published : November 2011

Format
PDF

Format
HARDCOPY



ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.




Standard NumberBS EN ISO 18113-3:2011
TitleIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
StatusCurrent
Publication Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 14971, ISO 15223-1, ISO 18113-1, EN 980, IEC 61010-1, IEC 61010-2-101, IEC 61326-2-6, IEC 62366
Informative References(Provided for Information)ISO/IEC Directives Part 2, ISO 18113-2, EN 591
ReplacesBS EN ISO 18113-3:2009
International RelationshipsEN ISO 18113-3:2011,ISO 18113-3:2009
DescriptorsDiagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Clinical laboratory equipment, Health service personnel
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Instruments de diagnostic in vitro à usage professionnel
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal
CommitteeCH/212
ISBN978 0 580 76942 9
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size1.037 MB
Price£130.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Customers who bought this product also bought

  • BS EN ISO 18113-1:2011
    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
  • BS EN ISO 18113-2:2011
    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
  • BS EN 13612:2002
    Performance evaluation of in vitro diagnostic medical devices
  • BS EN ISO 23640:2015
    In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents