ISO/TS 11137-4:2020
Sterilization of health care products — Radiation — Part 4: Guidance on process control
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General
3.2 Symbols
4 Principles applied in validating and controlling an irradiation process
4.1 General
4.2 Use of the dose measurement at the monitoring location
4.2.1 General
4.2.2 Dmon as an indirect measurement of dose to product
4.2.3 Dmon as a process monitor
4.2.4 Dmin or Dmax as a direct measurement of dose to product
4.3 Monitoring of critical process parameters
5 Establishing process target doses
5.1 Inputs and steps in establishing a process target dose
5.1.1 General
5.1.2 Process validation inputs (installation, operational and performance qualification)
5.1.3 Additional inputs
5.1.4 Determine σprocess
5.1.5 Product dose specifications
5.1.6 Select coverage factor k
5.1.7 Setting process target doses
5.1.8 Analyse process output
5.1.9 Review
5.2 Performance qualification outputs
5.2.1 General
5.2.2 Experimental design for PQ
5.2.3 Processing categories
5.3 Components of σprocess
5.3.1 General
5.3.2 Components related to measurement uncertainty
5.3.3 Components related to process variability
5.3.4 Combining components of uncertainty
5.3.5 Reducing σprocess
5.4 Establishing process target doses
5.4.1 Coverage factors
5.4.2 Process factors
5.4.3 Choice of target processing parameters
5.4.4 Assessing process capability
6 Routine monitoring and control
6.1 General
6.2 Product handling
6.2.1 Receipt of product
6.2.2 Loading
6.2.3 Unloading
6.2.4 Storage
6.2.5 Shipment
6.3 Processing of product
6.3.1 General
6.3.2 Processing parameters
6.3.3 Location of dosimeters
6.3.4 Partially filled containers
6.3.5 Process interruptions
6.3.6 Transitions between densities
6.4 Special processing conditions
6.4.1 Off-carrier processing
6.4.2 Irradiation of product under modified environmental conditions
6.5 Process output interpretation
6.5.1 General
6.5.2 Using an acceptance range based on Dmonster and Dmonmax,acc
6.5.3 Using an acceptance range with alert and action levels
6.5.4 Using an acceptance range based on process monitoring
6.5.5 Investigation of a dose measurement outside of expectation
6.6 Collection and analysis of data
6.6.1 General
6.6.2 Dosimeter data trending
6.6.3 Parametric data trending
6.6.4 Statistical process control
7 Release of product from the irradiation process
8 Maintaining process effectiveness
8.1 General
8.2 Assessment of changes made to the product
8.3 Assessment of changes made to the equipment
Annex A (informative) Examples of setting process target dose ranges and interpretation of process output
Bibliography
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Related Information
Similar Standards
-
AS/NZS ISO 11137.1:2006
Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
-
AS/NZS ISO 11137.3:2006
Sterilization of health care products - Radiation - Guidance on dosimetric aspects
-
BS EN 556-1:2024
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
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BS EN 556-1:2024 - TC
Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General
3.2 Symbols
4 Principles applied in validating and controlling an irradiation process
4.1 General
4.2 Use of the dose measurement at the monitoring location
4.2.1 General
4.2.2 Dmon as an indirect measurement of dose to product
4.2.3 Dmon as a process monitor
4.2.4 Dmin or Dmax as a direct measurement of dose to product
4.3 Monitoring of critical process parameters
5 Establishing process target doses
5.1 Inputs and steps in establishing a process target dose
5.1.1 General
5.1.2 Process validation inputs (installation, operational and performance qualification)
5.1.3 Additional inputs
5.1.4 Determine σprocess
5.1.5 Product dose specifications
5.1.6 Select coverage factor k
5.1.7 Setting process target doses
5.1.8 Analyse process output
5.1.9 Review
5.2 Performance qualification outputs
5.2.1 General
5.2.2 Experimental design for PQ
5.2.3 Processing categories
5.3 Components of σprocess
5.3.1 General
5.3.2 Components related to measurement uncertainty
5.3.3 Components related to process variability
5.3.4 Combining components of uncertainty
5.3.5 Reducing σprocess
5.4 Establishing process target doses
5.4.1 Coverage factors
5.4.2 Process factors
5.4.3 Choice of target processing parameters
5.4.4 Assessing process capability
6 Routine monitoring and control
6.1 General
6.2 Product handling
6.2.1 Receipt of product
6.2.2 Loading
6.2.3 Unloading
6.2.4 Storage
6.2.5 Shipment
6.3 Processing of product
6.3.1 General
6.3.2 Processing parameters
6.3.3 Location of dosimeters
6.3.4 Partially filled containers
6.3.5 Process interruptions
6.3.6 Transitions between densities
6.4 Special processing conditions
6.4.1 Off-carrier processing
6.4.2 Irradiation of product under modified environmental conditions
6.5 Process output interpretation
6.5.1 General
6.5.2 Using an acceptance range based on Dmonster and Dmonmax,acc
6.5.3 Using an acceptance range with alert and action levels
6.5.4 Using an acceptance range based on process monitoring
6.5.5 Investigation of a dose measurement outside of expectation
6.6 Collection and analysis of data
6.6.1 General
6.6.2 Dosimeter data trending
6.6.3 Parametric data trending
6.6.4 Statistical process control
7 Release of product from the irradiation process
8 Maintaining process effectiveness
8.1 General
8.2 Assessment of changes made to the product
8.3 Assessment of changes made to the equipment
Annex A (informative) Examples of setting process target dose ranges and interpretation of process output
Bibliography