Back

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)

General information
Valid from 04.08.2014
Base Documents
ISO 11135:2014; EN ISO 11135:2014

Standard history

Status
Date
Type
Name
02.12.2019
Amendment
04.08.2014
Main
07.05.2009
Corrigendum
09.01.2009
Main
04.07.2007
Main
EN ISO 11135 describes requirements for ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings.

Compliance with EN ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence.

Exposure to a properly validated, accurately controlled sterilization process is not the only factor
associated with the provision of reliable assurance that the product is sterile.

Attention is therefore given to several considerations in EN ISO 11135:

— the microbiological status of incoming raw materials,
— the validation and routine control of any cleaning and disinfection procedures used on the product,
— the control of the environment in which the product is manufactured or reprocessed, assembled
and packaged,
— the control of equipment and processes,
— the control of personnel and their hygiene,
— the manner and materials in which the product is packaged,
— the conditions under which product is stored.

The development, validation and routine control of a sterilization process comprises a number of discrete but interrelated activities. Such can be calibration, maintenance, product definition, process definition, installation qualification, operational qualification and performance qualification.

The international standard has been approved in Europe as EN ISO 11135:2014 without any changes and it supersedes EN ISO 11135-1:2007.
*
*
*
PDF
33.60 € incl tax
Paper
33.60 € incl tax
Browse standard for 24 hours: 2.40 € incl tax
Standard monitoring

Customers who bought this item also bought

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

EVS-EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Valid from 09.01.2009
Main + amendment

EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)
Newest version Valid from 17.08.2020
Main

EVS-EN ISO 11137-1:2015

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Newest version Valid from 02.07.2015