-
-
Available Formats
- Options
- Availability
- Priced From ( in USD )
-
Available Formats
-
- Immediate download
- $180.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $180.00
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 13408-1:2023
Priced From $250.00 -
ISO 11737-1:2018
Priced From $223.00 -
ISO 11138-1:2017
Priced From $223.00 -
ISO 11135:2014
Priced From $250.00
About This Item
Full Description
ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
Document History
-
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- Most Recent
-
ISO/TS 11135-2:2008
viewing
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1- Historical Version
-
ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices- Historical Version
-
ISO 11135:1994
Medical devices -- Validation and routine control of ethylene oxide sterilization- Historical Version