Din en iso 10431 and din 53479 are the standards corresponding to international standards iso 10431 and iso 1183, respectively, referred to in clause 2 of the en. Find the most uptodate version of bs en 1041 at engineering360. This is an incomplete list of din standards the status column gives the latest known status of the standard. Information supplied by the manufacturer with medical devices. This european standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by council directive 90385eec relating to active implantable medical devices and council directive 9342eec concerning medical devices. Directorategeneral for internal market, industry, entrepreneurship and smes. Perinorm is a bibliographic database of national, european and international standards from over 200 organizations in 23 countries, a total of more than 1,400,000. This standard does not cover requirements for provision of information for in vitro.
Bs en 1041 specifies requirements for information to be supplied by. Ssen1041 information supplied by the manufacturer of. Medical devices internal market, industry, entrepreneurship. Subscribe on standards with our subscription service. The first edition of this standard was drafted in a period when the active implantable medical device directive aimdd90385eec and the medical device directive mdd9342eec were relatively new and the in vitro diagnostic medical.
It also lists symbols that satisfy the requirements of this document. Homepagedin standards din en 1041 information supplied by the manufacturer of medical devices. Information supplied by the manufacturer of medical devices ssen 1041. Amounts paid or permanently set aside for charitable purposes from gross income. Information supplied by the manufacturer of medical devices format.
The medical instruments covered are regulated by the council directive 90385eec and relate to active surgical implants. Bs en 1041 gives practical requirements for the information that has to be supplied by a manufacturer of medical equipment. Please note that this standard has not yet been harmonised and thus cannot be used for ce marking. Din en 1041 2012 information supplied by the manufacturer of medical devices. We have books that facilitate standards compliance. En 1041, information supplied by the manufacturer of medical devices. Simple online access to standards, technical information and regulations. It is worth remembering that en 1041 is a cen standard so is purely european in its outlook. All bsi british standards available online in electronic and print formats. Ss en 1041 information supplied by the manufacturer of medical devices.
Elle presente une refonte importante par rapport a ledition precedente. New amendment 1 issued for bs en 1041 document centers. Din en 1041 information supplied by the manufacturer of medical devices. This standard specifies the information that must be supplied with each medical device sold in europe. Din en 1041 information supplied by the manufacturer of medical devices includes amendment a1. Find the most uptodate version of en 1041 at engineering360. This document is available in either paper or pdf format. This international standard provides essential performance and safety requirements for orotracheal and nasotracheal tubes and tracheal tube connectors. This european standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by council directive 90385eec relating to active. References to the en 980 have been removed, since that document has been cancelled and replaced by bs en iso 152231. Standard and the essential requirements of eu directive 9342ec annex zb informative relationship between this european. European standards en are documents that have been ratified by one of the 3 european standards organizations, cen, cenelec or etsi. If a standard has been withdrawn and no replacement specification is listed, either the specification was withdrawn without replacement or a replacement specification could not be identified. The amendment has made a number of changes to the en 1041 document, all of which are clearly marked in the bs adoption document.
Table of contents show below hide below foreword introduction 1 scope 2 normative references. Bs en 1041 sets out clear guidelines on how the directives requirements can be met. This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by council directive 90385eec relating to active implantable medical devices and council directive 9342eec concerning medical devices. Cen en 1041 information supplied by the manufacturer of. The following bibliographic material is provided to assist you with your purchasing decision. Bsen1041 information supplied by the manufacturer of. Cen en 1041 information supplied by the manufacturer of medical devices. I cant say exactly what that gives you as i cant read dutch. In compliance with the specifications of the standards listed can be presumed to.
Until harmonisation of this standard has been achieved, please use one of the following standards. They are designed and created by all interested parties through a transparent, open and consensual process. For information about the content and availability of european standards, please contact the european standardisation organisations. Moreover, there are a lot of iso and iec standards that were accepted as european standard headlined as en iso xxxxx and are valid in the european economic region. Bsen1041 information supplied by the manufacturer of medical. I think that the amendment is available on its own from the dutch standards body for 15euro. Le norme pdf scaricabili da uni store sono protette da digital rights management drm. Category health care technology pharmaceutics pharmaceutics in general medical equipment medical equipment. Dont complete for a simple trust or a pooled income fund. The first edition of this standard was drafted in a period when the active implantable medical device directive aimdd90385eec and the medical device directive mdd9342eec were relatively new. Functional safety of electrical, electronic and programmable electronic control systems. Form 1040sr department of the treasuryinternal revenue service. Bsen1041 information supplied by the manufacturer of medical devices documents.
Information supplied by the manufacturer of medical devices. When you use our service you can be assured the latest editions and easy access. There are not many significant changes from the previous version of en 1041 released in 1998. Or download the pdf of the directive or of the official journal for free. Medical equipment, implants surgical, medical instruments, technical documents, instructions for use, handbooks, documents, marking, identification. The principal changes are the addition of clauses on the provision of information on the safe and effective use of the device 5. Information supplied by the manufacturer of medical devices ss en 1041. As such, it really just transposes the applicable essential requirements. Get a quote for certification of systems, products or services, and get certified. It does not specify the language to be used for such information, nor does it specify the means by. European standards are a key component of the single european market.
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