Back

EVS-EN ISO 10993-7:2008+A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + ISO 10993-7:2008/Amd 1:2019)

General information

Valid from 01.02.2022
Base Documents
ISO 10993-7:2008; EN ISO 10993-7:2008; ISO 10993-7:2008/Cor 1:2009; EN ISO 10993-7:2008/AC:2009; ISO 10993-7:2008/Amd 1:2019; EN ISO 10993-7:2008/A1:2022
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 10993-7
01.02.2022
Main + amendment
EVS-EN ISO 10993-7:2008+A1:2022
01.02.2022
Amendment
EVS-EN ISO 10993-7:2008/A1:2022
06.01.2010
Corrigendum
EVS-EN ISO 10993-7:2008/AC:2009
09.01.2009
Main
EVS-EN ISO 10993-7:2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene
chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO
and ECH, and methods for determining compliance so that devices may be released. Additional
background, including guidance and a flowchart showing how this document is applied, are also included
in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this
part of ISO 10993.
NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Required fields are indicated with *

*
*
*
PDF
39.04 € incl tax
Paper
39.04 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 823 KB)

Related products

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
Main

EVS-EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Newest version Valid from 15.04.2021

Customers who bought this item also bought

Main

EVS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Newest version Valid from 04.08.2014
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019
Main + amendment

EVS-EN ISO 13485:2016+A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 16.09.2021
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

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