KS P ISO 11137-1:2008
Sterilization of health care products－Radiation－Part 1：Requirements for development, validation and routine control of a sterilization process for medical devices

Standard No.

KS P ISO 11137-1:2008

Release Date

2008

Published By

Korean Agency for Technology and Standards (KATS)

Status

Be replaced

Replace By

KS P ISO 11137-1:2019

Latest

KS P ISO 11137-1-2022

Scope

1.1 This standard covers the preparation, verification, and routine operation of the medical device sterilization process using radiation.

KS P ISO 11137-1:2008 history

• 2022 KS P ISO 11137-1-2022 Sterilization of health care products ─ Radiation ─ Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 2019 KS P ISO 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 2008 KS P ISO 11137-1:2008 Sterilization of health care products－Radiation－Part 1：Requirements for development, validation and routine control of a sterilization process for medical devices