Back

EVS-EN ISO 10993-9:2010

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

General information

Withdrawn from 15.10.2021
Base Documents
ISO 10993-9:2009; EN ISO 10993-9:2009
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.10.2021
Main
EVS-EN ISO 10993-9:2021
04.03.2010
Main
EVS-EN ISO 10993-9:2010
Main
EVS-EN ISO 10993-9:2009
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials.

Required fields are indicated with *

*
*
*
PDF
15.86 € incl tax
Paper
15.86 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 355 KB)

Related products

Main

EVS-EN ISO 10993-9:2021

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Newest version Valid from 15.10.2021
Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Newest version Valid from 02.10.2020
Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Newest version Valid from 31.12.2020
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

Customers who bought this item also bought

Main

EVS-EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Newest version Valid from 04.10.2010
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 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
Withdrawn from 01.12.2023
Main

EVS-EN ISO 10993-18:2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials
Withdrawn from 15.06.2020

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English