GSO ISO 11138-2:2021

ISO 11138-2:2017
Gulf Standard   Current Edition · Approved on 01 July 2021

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

GSO ISO 11138-2:2021 Files

English 6 Pages
Current Edition Reference Language
BHD 21.33

GSO ISO 11138-2:2021 Scope

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

NOTE 2 National or regional regulations can provide requirements for work place safety.

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023 
Bahraini Standard
Personal Care and Baby Wet Wipes
BH GSO 2241:2023
GSO 2241:2023 
Bahraini Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners

Recently Published from Health Sector

GSO EN 16120:2012+A2:2025
EN 16120:2012+A2:2016 
Gulf Standard
Child use and care articles - Chair mounted seat
GSO ASTM F1235:2025
ASTM F1235:18 
Gulf Standard
Standard Consumer Safety Specification for Portable Hook-On Chairs
GSO ISO 24805:2025
ISO 24805:2022 
Gulf Standard
Recreational diving services — Requirements for rebreather diver training — Decompression diving to 45 m
GSO ISO 18725:2025
ISO 18725:2024 
Gulf Standard
Tourism and related services — Yacht harbours and dry stacks — Requirements for clean harbours and active biodiversity harbours