ISO/TS 11137-4:2020 PDF

Name: ISO/TS 11137-4:2020 — Sterilization of health care products — Radiation — Part 4: Guidance on process control
SKU: ISO/TS 11137-4:2020
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Sterilization of health care products — Radiation — Part 4: Guidance on process control

Название (английский):

ISO/TS 11137-4:2020

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 55
Дата публикации:: 30 июня 2020 г.
Издание:: ISO TS 11137 edition 1 version 1
ICS:: 11.080.01

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Описание (английский):

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.

Abstract

Overview

Key topics and technical requirements

Process target dose establishment: Inputs and steps for determining process target doses, selection of coverage factors, and assessing process capability.
Dosimetry and monitoring: Use of dose measurements at monitoring locations, interpretation of Dmon, Dmin, Dmax measurements, and guidance on dosimeter placement.
Validation stages: Guidance tied to installation, operational and performance qualification (IQ/OQ/PQ) outputs and experimental designs for PQ.
Uncertainty and sigma (σprocess): Identification and combination of measurement and process variability components, and strategies to reduce overall uncertainty.
Routine monitoring and control: Best practices for product handling (receipt, loading, unloading), processing parameters, handling partially filled containers, process interruptions, and special conditions (off‑carrier processing, modified environments).
Process output interpretation and statistical tools: Use of acceptance ranges, alert/action levels, trend analysis, and statistical process control to decide on product release or investigation.
Maintaining process effectiveness: Assessing changes to product or equipment and ensuring ongoing conformity with dose specifications.

Practical applications and who uses it

ISO/TS 11137-4:2020 is intended for professionals involved in radiation sterilization and quality management, including:

Medical device manufacturers and contract sterilization service providers
Validation engineers and process control specialists
Dosimetrists and laboratory personnel performing routine and qualification dosimetry
Quality assurance and regulatory compliance teams responsible for demonstrating conformity with sterilization dose requirements

Typical uses include defining process target doses during validation, designing dosimetry programs, developing acceptance criteria and control charts, investigating excursions, and documenting ongoing process capability for regulatory submissions and audits.

Related standards

ISO 11137-1 - Requirements for development, validation and routine control
ISO 11137-2 - Establishing dose for sterilization based on bioburden and SAL
ISO 11137-3 - Dosimetric requirements and methods
ISO/TS 13004 - Guidance on sterilization dose setting for non‑viable bioburden

Keywords: ISO/TS 11137-4:2020, radiation sterilization, process control, dosimetry, gamma sterilization, electron beam, X-irradiation, medical device sterilization, validation, routine monitoring.

Технические детали

Технический комитет: ISO/TC 198 - Sterilization of health care products
SKU: ISO/TS 11137-4:2020

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ISO 11137-2:2013/Amd 1:2022

Действующий

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1

Overview ISO 11137-2:2013/Amd 1:2022 is an authoritative international standard focused on the sterilization of health care products using radiation. Specifically, it provides amendments to Part 2 of…

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ISO 11137-1:2006/Amd 2:2018

Отменён

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and rout…

Overview ISO 11137-1:2006/Amd 2:2018 is an important amendment to the international standard for the sterilization of healthcare products using radiation. This document focuses on requirements for th…

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SIST EN ISO 11137-3:2017

Действующий

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, va…

Overview EN ISO 11137-3:2017 - "Sterilization of health care products - Radiation - Part 3" provides guidance on dosimetric aspects used during the development, validation and routine control of radi…

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PD CEN ISO/TS 13004:2014