Standard Svensk standard · SS-EN 1041:2008+A1:2013

Information som skall tillhandahållas av tillverkare av medicintekniska produkter

Status: Upphävd

· Ersätts av: SS-EN ISO 20417:2021 , SS-EN ISO 20417:2021
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Standard Svensk standard · SS-EN 1041:2008+A1:2013

Information som skall tillhandahållas av tillverkare av medicintekniska produkter
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Omfattning
This European 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.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

Ämnesområden

Dokumentation av tekniska produkter (01.110) Medicinsk utrustning allmänt (11.040.01) Medicintekniska kvalitetssystem (11.110.10) Farmakopéprodukter allmänt (11.120.01)


Köp denna standard

Standard Svensk standard · SS-EN 1041:2008+A1:2013

Information som skall tillhandahållas av tillverkare av medicintekniska produkter
Prenumerera på standarden - Läs mer Dölj
Pris: 1 197 SEK
standard ikon pdf

PDF

Pris: 1 197 SEK
standard ikon

Papper

Pris: 1 915,20 SEK
standard ikon pdf + standard ikon

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Produktinformation

Språk: Engelska

Framtagen av: Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik, SIS/TK 355

Internationell titel: Information supplied by the manufacturer of medical devices

Artikelnummer: STD-99565

Utgåva: 1

Fastställd: 2013-09-30

Antal sidor: 36

Ersätter: SS-EN 1041:2008

Ersätts av: SS-EN ISO 20417:2021 , SS-EN ISO 20417:2021