SS-EN-ISO-11135 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)

SS-EN-ISO-11135 - 2014 EDITION - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Included in this current edition are the following subparts:

 2014 EDITION - July 24, 2014
 FOR 2014 EDITION AMENDMENT 1 SEE - Nov. 28, 2019

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)


Active implantable medical devices. Medical devices

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

ORDER

Price:

$373.35        


Want this as a site license?



Designation Name

SS-EN ISO 11135:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

July 24, 2014

Language(s)

English

Page Count

100

International Equivalent

EN ISO 11135:2014(IDT); ISO 11135:2014(IDT)