SIST EN ISO 11137-3:2017 PDF

Name: SIST EN ISO 11137-3:2017 — Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
SKU: SIST EN ISO 11137-3:2017
Price: 96.97 EUR
Availability: InStock

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Название (английский):

SIST EN ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 50
Дата публикации:: 12 сентября 2017 г.
ICS:: 11.080.01
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version750 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:9 раб. дн. (перевод)

Цена:750 €

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

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 radiation sterilization processes. It supports the requirements in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004 by describing best practice for dose measurement, calibration, uncertainty assessment and dosimetry-based decision making for gamma, electron beam and X‑ray sterilization.

Key topics and technical requirements

Dosimetry systems and calibration

Selection of appropriate dosimeters and dosimetry systems and traceability to national/international standards.
Calibration procedures and the need for documented calibration records.

Dose measurement and uncertainty

Principles for obtaining a best estimate of dose, and application of uncertainty evaluation (including GUM methodology).
Consideration of environmental effects (temperature, humidity) on dosimeter response.

Dose setting and limits

Guidance on establishing the maximum acceptable dose and the sterilization target dose based on dosimetric evidence.

Qualification stages (IQ/OQ/PQ)

Dosimetry requirements for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Specific considerations for gamma, electron beam and X‑ray irradiators, including loading patterns, dose mapping and data analysis.

Routine monitoring and control

Frequency and methods for routine dose measurements and process control to demonstrate ongoing conformance.

Informative annexes

Mathematical modelling, tables for dosimetry testing during IQ/OQ/PQ, tolerances and application of measurement uncertainty.

Practical applications and who uses this standard

Medical device manufacturers establishing sterilization processes and documentation for product release.

Contract sterilization facilities (gamma, e‑beam, X‑ray) performing dose mapping, commissioning and routine control.

Quality assurance and regulatory teams preparing technical files and demonstrating compliance with sterilization standards.

Dosimetrists and process engineers implementing calibration, uncertainty analysis and dose-monitoring programs.

Practical uses include selecting and calibrating dosimeters, designing dose-mapping studies, setting process target doses, performing IQ/OQ/PQ activities, and defining routine dose-monitoring frequency to maintain validated sterilization performance.

Related standards

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

ISO 11137‑2 (Establishing sterilization dose)

ISO/TS 13004 (Guidance on developing sterilization dose substantiation)

Guide to the expression of uncertainty in measurement (GUM) - referenced for uncertainty evaluation

EN ISO 11137‑3:2017 is essential for anyone responsible for radiation sterilization dosimetry, ensuring traceable, reproducible dose measurements and compliant validation and control of sterile healthcare products.

SIST EN ISO 11137-3:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses this standard

Related standards

Технические детали

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…