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BSI PD ISO/TS 11137-4:2020

BSI PD ISO/TS 11137-4:2020

$198.66

Sterilization of health care products. Radiation – Guidance on process control

Published By Publication Date Number of Pages
BSI 2020 64
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General
11 3.2 Symbols
12 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
13 4.2.4 Dmin or Dmax as a direct measurement of dose to product
4.3 Monitoring of critical process parameters
14 5 Establishing process target doses
5.1 Inputs and steps in establishing a process target dose
5.1.1 General
15 5.1.2 Process validation inputs (installation, operational and performance qualification)
5.1.3 Additional inputs
5.1.4 Determine σprocess
16 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
17 5.2.2 Experimental design for PQ
5.2.3 Processing categories
18 5.3 Components of σprocess
5.3.1 General
19 5.3.2 Components related to measurement uncertainty
20 5.3.3 Components related to process variability
21 5.3.4 Combining components of uncertainty
5.3.5 Reducing σprocess
24 5.4 Establishing process target doses
5.4.1 Coverage factors
25 5.4.2 Process factors
5.4.3 Choice of target processing parameters
26 5.4.4 Assessing process capability
6 Routine monitoring and control
6.1 General
27 6.2 Product handling
6.2.1 Receipt of product
6.2.2 Loading
6.2.3 Unloading
28 6.2.4 Storage
6.2.5 Shipment
6.3 Processing of product
6.3.1 General
6.3.2 Processing parameters
29 6.3.3 Location of dosimeters
6.3.4 Partially filled containers
6.3.5 Process interruptions
30 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
32 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
33 6.5.4 Using an acceptance range based on process monitoring
34 6.5.5 Investigation of a dose measurement outside of expectation
35 6.6 Collection and analysis of data
6.6.1 General
6.6.2 Dosimeter data trending
36 6.6.3 Parametric data trending
37 6.6.4 Statistical process control
38 7 Release of product from the irradiation process
39 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
40 Annex A (informative) Examples of setting process target dose ranges and interpretation of process output
63 Bibliography

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BSI PD ISO/TS 11137-4:2020
$198.66