KS P ISO 11135:2008
Medical devices－Validation and routine control of ethylene oxide sterilization

Standard No.

KS P ISO 11135:2008

Release Date

2008

Published By

Korean Agency for Technology and Standards (KATS)

Status

Be replaced 2014-12

Replace By

KS P ISO 11135-1:2014

Latest

KS P ISO 11135-2022

Replace

KS P ISO 11135:2003

Scope

1.1 This standard sets out requirements for validation and routine control of ethylene oxide sterilization processes for medical devices.

KS P ISO 11135:2008 history

• 2022 KS P ISO 11135-2022 Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices
• 2018 KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
• 2014 KS P ISO 11135-1:2014 Sterilization of health care products — Ethylene oxide
• 2008 KS P ISO 11135:2008 Medical devices－Validation and routine control of ethylene oxide sterilization
• 0000 KS P ISO 11135:2003