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
(317)
ACI
(572)
AISC
(43)
ASA
(234)
ASCE
(969)
ASHRAE
(643)
ASME
(2114)
ASSE
(64)
ASTM
(92448)
AWC
(54)
AWWA
(535)
BHMA
(117)
BICSI
(31)
BIFMA
(20)
BOMA
(19)
BSI
(92811)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(351)
ICC
(300)
IEEE
(6023)
IES
(239)
ISEA
(16)
Joint Commission
(177)
Joint Commission Int.
(1)
NETA
(5)
NFPA
(1621)
TCNA
(16)
TMS
(18)
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
(23)
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 45502-1:2015 Implants for surgery. Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
    Edition: 2015
    $497.46
    / user per year

Description of BS EN 45502-1:2015 2015

This part of EN 45502 specifies requirements that are generally applicable to active implantable medical devices.

NOTE 1 For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.

The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.

This part of EN 45502 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).

This part of EN 45502 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

NOTE 2 The device that is commonly referred to as an active implantable medical device can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 3 In this part of EN 45502, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.



Standard NumberBS EN 45502-1:2015
TitleImplants for surgery. Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
StatusDefinitive
Publication Date2015-06-30
ReplacesBS EN 45502-1:1998
Identical National Standard OfEN 45502-1:2015
DescriptorsUltrasonic hazards, Voltage, Radio-wave hazards, Leakage currents, Electrical medical equipment, Defibrillators, Ultrasonic testing, Temperature, Durability, Electrical safety, Delivery, Electrostatics, Sterile equipment, Hazards, Mechanical testing, Safety measures, Accident prevention, Electromagnetic compatibility, Biological analysis and testing, Life (durability), Performance, Packaging, Thermal testing, Instructions for use, Impulse-voltage tests, Medical equipment, Electric charge, Compatibility, Electrical testing, Implants (surgical), Electrically-operated devices, Design, Prosthetic devices, Marking, Reliability, Packages, Environmental testing, Protected electrical equipment, Endurance testing, Test equipment, Dielectric-strength tests, Testing conditions
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 72639 2
PublisherBSI
Pages64

The following editions for this book are also available...

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