ISO/TS 11137-4:2020

Sterilization of health care products — Radiation — Part 4: Guidance on process control

Publication date: Jun 30, 2020

General information

Current stage: 90.93 Effective date: Feb 16, 2024

Originator: ISO

Owner: ISO/TC 198

Type: Technical Specification

ICS: 11.080.01

Languages: English

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Status: Published

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Scope

This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

Life cycle

NOW

PUBLISHED
ISO/TS 11137-4:2020
90.93 Standard confirmed
Feb 16, 2024

National adoptions

DS ISO/TS 11137-4:2020

DPS

Sterilization of health care products — Radiation — Part 4: Guidance on process control

60.60 Standard published

DPS/KT 205 more