BS EN ISO 18113-4:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

BS EN ISO 18113-4:2011

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing

Status : Current   Published : November 2011

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 18113-4:2011
TitleIn vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
StatusCurrent
Publication Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 14971, ISO 15223-1, ISO 18113-1, EN 980
Informative References(Provided for Information)ISO 15197, ISO 17593, ISO 18113-5, ISO/IEC Directives Part 2, EN 376:2002, CLSI C28-A2:2000, CLSI GP10-A:1995, 98/79/EC
ReplacesBS EN ISO 18113-4:2009
International RelationshipsEN ISO 18113-4:2011,ISO 18113-4:2009
Amended ByCorrigendum, January 2012.
DescriptorsDiagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Containers, Consumers
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Réactifs de diagnostic in vitro pour auto-tests
Title in GermanIn-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. Reagenzien für in-vitrodiagnostische Untersuchungen zur Eigenanwendung
CommitteeCH/212
ISBN978 0 580 77329 7
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size1.597 MB
Price£182.00


 Your basket
Your basket is empty

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


Tracked Changes

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


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


BSOL

The faster, easier way to work with standards


Customers who bought this product also bought

  • BS EN ISO 18113-5:2011
    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing
  • 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 ISO 18113-3:2011
    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use