ISO 11137-3:2017 PDF

Name: ISO 11137-3:2017 — Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
SKU: ISO 11137-3:2017
Price: 25 EUR
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Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

Название (английский):

ISO 11137-3:2017

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 41
Дата публикации:: 26 июня 2017 г.
Издание:: ISO IS 11137 edition 2 version 1
ICS:: 11.080.01

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Описание (английский):

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11137-3:2017 - "Sterilization of health care products - Radiation - Part 3" provides non‑normative guidance on dosimetric aspects for the development, validation and routine control of radiation sterilization processes. It explains how to meet the dosimetry requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004, focusing on dose measurement, traceability and uncertainty for gamma, electron beam and X‑ray sterilization.

Key topics and requirements

Dosimetry fundamentals

Definitions (absorbed dose, dose uniformity ratio, direct vs indirect measurements).
Dosimetry system components (dosimeters, instruments, reference standards, procedures).

Dose measurement and uncertainty

Selection and calibration of dosimetry systems and the need for traceability to national/international standards.
Application of the Guide to the Expression of Uncertainty (GUM) and radiation‑specific uncertainty considerations.
Best estimate of dose and how environmental factors (temperature, humidity) affect dosimeter response.

Sterilization dose activities

Guidance on establishing the maximum acceptable dose and the sterilization dose used for product substantiation and routine processing.

Qualification and validation (IQ/OQ/PQ)

Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) guidance for gamma, electron beam and X‑ray irradiators.
Loading patterns, dose mapping, dosimetry approaches and analysis of dose mapping data.

Routine monitoring and control

Frequency and methods for routine dose measurements and control to ensure ongoing process consistency.

Informative annexes

Mathematical modelling, recommended dosimetry testing during IQ/OQ/PQ, tolerances and uncertainty application in dose setting.

Practical applications and users

ISO 11137-3:2017 is intended for professionals involved with radiation sterilization of medical devices and health care products, including:

Sterilization validation engineers and process owners

Quality and regulatory affairs specialists (ISO 13485 stakeholders)

Dosimetrists and calibration laboratories

Irradiator operators (gamma, e‑beam, X‑ray)

Contract sterilization service providers

Use cases:

Designing and validating a radiation sterilization process

Selecting and calibrating dosimetry systems and establishing measurement traceability

Performing IQ/OQ/PQ and dose mapping for irradiators

Implementing routine monitoring and documenting dose measurement uncertainty for regulatory compliance

Related standards

ISO 11137-1 - Requirements for development, validation and routine control

ISO 11137-2 - Establishing the sterilization dose

ISO/TS 13004 - Substantiation of a selected sterilization dose (VDmax method)

ISO 13485 - Quality management systems for medical devices

Keywords: ISO 11137-3:2017, radiation sterilization, dosimetry, dose measurement, dose uncertainty, sterilization validation, IQ OQ PQ, medical device sterilization.

ISO 11137-3:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications and users

Related standards

Технические детали

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…

SIST EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)