Buy ISO 11135:2014 | Intertek Inform

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Amended by

ISO 11135:2014/Amd 1:2018

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

07-07-2014

Publisher

International Organization for Standardization

Add to Watchlist

US$321.00

Excluding Tax where applicable

Summarise this standard

AI-generated summary

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.

Committee	ISO/TC 198
DevelopmentNote	Supersedes ISO/DIS 11135, ISO 11135-1 and ISO TS 11135-2. (07/2014)
DocumentType	Standard
Pages	78
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11135:1994 ISO/TS 11135-2:2008/Cor 1:2009 ISO 11135-1:2007 ISO/TS 11135-2:2008

Standards	Relationship
JIS T 0801:2016	Identical
AAMI TIR74 : 2016	Identical
NF EN ISO 11135:2014	Identical
NBN EN ISO 11135 : 2014	Identical
ANSI/AAMI/ISO 11135:2014	Identical
NEN EN ISO 11135 : 2014	Identical
EN ISO 11135:2014	Identical
GOST ISO 11135 : 2012	Identical
SS-EN ISO 11135:2014	Identical
I.S. EN ISO 11135:2014	Identical
BS EN ISO 11135:2014	Identical
DIN EN ISO 11135:2014-10	Identical
PN EN ISO 11135 : 2014	Identical
NS EN ISO 11135 : 2014	Identical
I.S. EN ISO 11135:2014&A1:2019	Identical
SAC GB 18279 : 2000	Identical
UNE-EN ISO 11135:2015	Identical
GOST R ISO 11135 : 2000	Identical

Frequently Asked Questions

ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. It is an international standard published by International Organization for Standardization (ISO).

ISO 11135 is used by medical device manufacturers and sterilisation service providers using ethylene oxide. It is an international standard published by International Organization for Standardization (ISO).

ISO 11135 is International Organization for Standardization (ISO)'s standard for ethylene oxide sterilisation of healthcare products, while ISO 11137-1 covers radiation sterilisation of healthcare products (International). ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

ISO 11135 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes. In practice it is applied by medical device manufacturers and sterilisation service providers using ethylene oxide.

US$321.00

Excluding Tax where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Shopping Cart

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

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Industry

Sub-Industry

What is the scope of ISO 11135?

Who is ISO 11135 written for?

What is the difference between ISO 11135 and ISO 11137-1?

Where does ISO 11135 apply?

What is ISO 11135 used for?