Please select and order
€98.22
excl. VAT
Add to cart
Norm

ÖNORM EN 1041

Issue date: 2008 11 01

Information supplied by the manufacturer with medical devices

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active im...
Withdrawn: 2013 11 15
This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
ÖVE/ÖNORM EN ISO 20417
2022 09 01
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version ...
Norm
ÖVE/ÖNORM EN ISO 20417
2021 11 15
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Norm
ÖNORM EN 1041
2013 11 15
Information supplied by the manufacturer of medical devices
Norm
ÖNORM EN 1041
2008 11 01
Information supplied by the manufacturer with medical devices
Norm
ÖNORM EN 1041
1998 07 01
Information supplied by the manufacturer with medical devices
Norm
Expand
Norm
ISO 639-1:2002
Issue date : 2002 07 18
Codes for the representation of names of languages — Part 1: Alpha-2 code
Norm
ISO 8601:2004
Issue date : 2004 12 03
Data elements and interchange formats — Information interchange — Representation of dates and times
Technische Regel
CEN/TR 15133
Issue date : 2005 06
Nomenclature - Collective terms and codes for groups of medical devices
Norm
ÖNORM EN ISO 3166-1
Issue date : 2007 03 01
Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2006)
Norm
ÖNORM EN ISO 15223-1
Issue date : 2012 10 15
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Norm
ISO 639-1:2002
Issue date : 2002 07 18
Codes for the representation of names of languages — Part 1: Alpha-2 code
Norm
ISO 1000:1992
Issue date : 1992 11 12
SI units and recommendations for the use of their multiples and of certain other units
Norm
ISO 8601:2004
Issue date : 2004 12 03
Data elements and interchange formats — Information interchange — Representation of dates and times
Technische Regel
CEN/TR 15133
Issue date : 2005 06
Nomenclature - Collective terms and codes for groups of medical devices
Norm
ÖNORM EN 1041
Issue date : 2013 11 15
Information supplied by the manufacturer of medical devices