CEN ISO/TS 11137-4:2023 PDF

Name: CEN ISO/TS 11137-4:2023 — Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
SKU: CEN ISO/TS 11137-4:2023
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Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

Название (английский):

CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 64
Дата публикации:: 21 июня 2023 г.
Издание:: CEN 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

Похожие стандарты

Стандарты, упомянутые в описании

Overview

CEN ISO/TS 11137-4:2023 (adoption of ISO/TS 11137-4:2020) provides guidance on process control for radiation sterilization of health care products. It supplements ISO 11137-3 and helps organizations meet requirements in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004. The Technical Specification focuses on establishing, validating and controlling sterilization processes using gamma, electron beam (e‑beam) and X‑irradiation, with emphasis on dosimetry, process monitoring and maintaining ongoing process capability.

Key Topics and Requirements

Principles of process validation and control

Use of monitoring dose measurements (Dmon) and product dose indicators.
Role of process qualification stages: Installation, Operational and Performance Qualification (IQ/OQ/PQ).

Establishing process target doses

Inputs for target dose setting: validation data, measurement uncertainty (σprocess), product dose specifications and coverage factors.
Components of process variability and measurement uncertainty; methods to combine and reduce σprocess.

Routine monitoring and control

Product handling (receipt, loading, unloading, storage and shipment) and their impact on dose distribution.
Placement and interpretation of dosimeters, handling partially filled loads and special processing conditions (off‑carrier, modified environments).
Accept/reject criteria: acceptance ranges, alert and action levels tied to monitoring locations and product dose.

Data analysis and statistical control

Trending of dosimeter and parametric data, use of statistical process control to detect shifts and maintain capability.

Release and maintenance

Criteria for product release from the irradiation process and management of changes to product or equipment that affect process effectiveness.

Informative annex with examples for setting target dose ranges and interpreting outputs.

Practical Applications and Who Uses It

This TS is intended for:

Medical device manufacturers and contract sterilization providers implementing radiation sterilization.

Sterilization engineers, QA/RA professionals, and validation teams responsible for establishing and controlling sterilization cycles.

Regulatory and compliance teams needing documented, standards‑based process control approaches for audits and submissions.

Use cases:

Designing validation protocols (PQ) and choosing dosimetry strategies.

Defining acceptance ranges, alert/action thresholds and statistical monitoring plans.

Assessing the effect of product loading patterns, density transitions and process interruptions on dose delivery.

Related Standards

ISO 11137‑1 (requirements for development, validation and routine control)

ISO 11137‑2 (dose setting methods)

ISO 11137‑3 (dosimetric methods)

ISO/TS 13004 (guidance on bioburden)

Keywords: CEN ISO/TS 11137‑4:2023, radiation sterilization, sterilization process control, gamma sterilization, e‑beam, X‑irradiation, dosimetry, process validation, dose monitoring, medical device sterilization.

CEN ISO/TS 11137-4:2023 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications and Who Uses It

Related Standards

Технические детали

SIST EN ISO 11137-3:2017

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

ISO 11137-1:2006/Amd 2:2018

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

ISO 11137-2:2013/Amd 1:2022

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

PD CEN ISO/TS 13004:2014

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDm…