EN 1441:1997

Medical devices - Risk analysis

General information

99.60 Withdrawal effective   Feb 27, 2002

CEN

CEN/BT

European Norm

11.040.01   Medical equipment in general

Scope

This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 1441:1997
99.60 Withdrawal effective
Feb 27, 2002

REVISED BY

WITHDRAWN
EN ISO 14971:2000