BS EN ISO 18113-1:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements

Standard No.

BS EN ISO 18113-1:2009

Release Date

2010

Published By

British Standards Institution (BSI)

Status

Be replaced 2011-10

Replace By

BS EN ISO 18113-1:2011

Latest

BS EN ISO 18113-1:2011

Scope

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

BS EN ISO 18113-1:2009 history

• 2011 BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
• 2010 BS EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements