Skip to main content
Back

EVS-EN ISO 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

General information

Withdrawn from 01.12.2023
Base Documents
ISO 10993-17:2002; EN ISO 10993-17:2009
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.12.2023
Main
07.08.2009
Main
Main
EVS-EN ISO 10993-17:2003
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.   This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

Required fields are indicated with *

*
*
*
PDF
24.40 € incl tax
Paper
24.40 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Valid from 15.06.2020
Main

EVS-EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Newest version Valid from 07.08.2009
Main

EVS-EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Newest version Valid from 18.06.2018
Main

EVS-EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Withdrawn from 01.03.2023