Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Home
Content
Tour
eLibrary
Store
Search book title
Enter keywords for book title search
Search book content
Enter keywords for book content search
Filters:
FORMAT
BOOKS
All Books
PACKAGES
All Packages
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(326)
ACI
(573)
AISC
(44)
ASA
(234)
ASCE
(969)
ASHRAE
(652)
ASME
(2114)
ASSE
(64)
ASTM
(92448)
AWC
(54)
AWWA
(541)
BHMA
(117)
BICSI
(33)
BIFMA
(20)
BOMA
(19)
BSI
(93277)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(351)
ICC
(300)
IEEE
(6217)
IES
(240)
ISEA
(16)
Joint Commission
(177)
Joint Commission Int.
(1)
NETA
(5)
NFPA
(1621)
TCNA
(16)
TMS
(19)
USGBC
(28)
WILEY
(4)
 
AR
(6)
AZ
(7)
CA
(115)
CT
(3)
FL
(57)
ID
(5)
IL
(5)
IN
(1)
KY
(1)
LA
(2)
MI
(25)
MN
(26)
NC
(27)
NJ
(13)
NY
(61)
OH
(24)
OR
(22)
PA
(7)
RI
(8)
SC
(20)
SD
(1)
TX
(3)
VA
(50)
VT
(6)
WA
(31)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Technical Bulletin
 All
  • BSI
    BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    Edition: 2013
    $411.69
    / user per year

Description of BS EN 1041:2008+A1:2013 2013

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. 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).

Standard NumberBS EN 1041:2008+A1:2013
TitleInformation supplied by the manufacturer of medical devices
StatusWithdrawn
Publication Date2013-10-31
Withdrawn Date2021-05-11
ReplacesBS EN 1041:1998
Replaced ByBS EN ISO 20417:2021
Identical National Standard OfEN 1041:2008+A1:2013
AmendsBS EN 1041:2008
DescriptorsDocuments, Sterile equipment, Safety measures, Packaging, Hazards, Medical equipment, Implants (surgical), Definitions, Marking, Handbooks, Identification methods, Symbols, Technical documents, Consumer-supplier relations, Instructions for use, Medical instruments
ICS11.040.01 Medical equipment in general, 01.110 Technical product documentation, 11.120.01 Pharmaceutics in general
CommitteeCH/210/3
ISBN978 0 580 80873 9
PublisherBSI
Pages28

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
GROUPS
X