BS EN 1041:1998 - Information supplied by the manufacturer with medical devices – BSI British Standards

BS EN 1041:1998

Information supplied by the manufacturer with medical devices

Status : Revised, Superseded, Withdrawn   Published : July 1998 Replaced By : BS EN 1041:2008+A1:2013

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


This European Standard specifies requirements for the information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.




Standard NumberBS EN 1041:1998
TitleInformation supplied by the manufacturer with medical devices
StatusRevised, Superseded, Withdrawn
Publication Date15 July 1998
Withdrawn Date01 August 2011
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN 1041:2008+A1:2013
International RelationshipsEN 1041:1998
Draft Superseded By93/502178 DC
DescriptorsMedical equipment, Implants (surgical), Medical instruments, Technical documents, Instructions for use, Handbooks, Documents, Marking, Identification methods, Packaging, Sterile equipment, Definitions, Consumer-supplier relations, Symbols, Safety measures, Hazards
ICS01.110
11.040.01
11.120.01
Title in FrenchInformations fournies par le fabricant avec les dispositifs medicaux
Title in GermanBereitstellung von Informationen durch den Hersteller eines Medizinprodukts
CommitteeCH/210/3
ISBN0 580 29800 0
PublisherBSI
FormatA4
DeliveryNo
Pages18
File Size180 KB
Price£130.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 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


Collaborate, Innovate, Accelerate.


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


Customers who bought this product also bought

  • BS EN 556-1:2001
    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices
  • BS EN ISO 17665-1:2006
    Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN 13612:2002
    Performance evaluation of in vitro diagnostic medical devices