DANSK DS/ISO/TR 15499 PDF

DANSK DS/ISO/TR 15499 PDF

Name:
DANSK DS/ISO/TR 15499 PDF

Published Date:
12/20/2016

Status:
[ Withdrawn ]

Description:

Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process

Publisher:
Dansk Standard

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$19.8
Need Help?
W/D NO S/S

ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.


Edition : 16
File Size : 1 file , 1.2 MB
Number of Pages : 24
Product Code(s) : DS-021, DS-021
Published : 12/20/2016

History

DANSK DS/ISO/TR 15499
Published Date: 12/20/2016
Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
$19.8
DANSK DS/ISO/TR 15499
Published Date: 09/07/2012
Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
$21.3

Related products

DANSK DSF/PREN 9131
Published Date:
Aerospace series – Quality Management Systems – Nonconformance Data Definition and Documentation
$8.7
DANSK DSF/FPREN 62290-2
Published Date:
Railway applications - Urban guided transport management and command/control systems -- Part 2: Functional requirements specification
$20.7
DANSK DS/EN IEC 63013
Published Date: 12/03/2019
LED packages – Long-term luminous and radiant flux maintenance projection
$18
DANSK DS/EN IEC 62087-2
Published Date: 04/04/2023
Audio, video, and related equipment – Determination of power consumption – Part 2: Signals and media
$27

Best-Selling Products

UNE-CEN ISO/TR 14969:2006 IN
Published Date: 02/15/2006
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
UNE-CEN ISO/TR 15462:2010 IN
Published Date: 09/15/2010
Water quality - Selection of tests for biodegradability (ISO/TR 15462:2006)
UNE-CEN ISO/TR 15608:2006 IN
Published Date: 07/19/2006
Welding - Guidelines for a metallic materials grouping system (ISO/TR 15608:2005)
UNE-CEN ISO/TR 17844:2007 IN
Published Date: 09/26/2007
Welding - Comparison of standardised methods for the avoidance of cold cracks (ISO/TR 17844:2004)
UNE-CEN ISO/TR 20572:2008 IN
Published Date: 12/17/2008
Footwear - Performance requirements for components for footwear - Accessories (ISO/TR 20572:2007)
UNE-CEN ISO/TR 20573:2009 IN
Published Date: 05/13/2009
Footwear - Performance requirements for components for footwear - Heels and top pieces (ISO/TR 20573:2006)