-
-
Available Formats
- Options
- Availability
- Priced From ( in USD )
-
Available Formats
-
- Immediate download
- $216.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $216.00
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- $325.20
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 13683:1997
Priced From $128.40 -
ISO/TS 15843:2000
Priced From $110.40 -
ISO 17664-1:2021
Priced From $199.20 -
ISO 11139:2018
Priced From $64.80
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