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BSI 23/30426672 DC 2023

BSI 23/30426672 DC 2023

$13.70

BS EN ISO 11137-1. Sterilization of health care products. Radiation – Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

Published By Publication Date Number of Pages
BSI 2023 55
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PDF Catalog

PDF Pages PDF Title
1 3042667-NC.pdf
3 ISO_DIS 11137-1 ed.2 – id.81721 Enquiry PDF (en).pdf
6 Foreword
8 Introduction
11 1 Scope
12 2 Normative references
3 Terms and definitions
19 4 General
20 5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process
6.2 Equipment
22 7 Product definition
8 Process definition
8.1 Establishing the maximum acceptable dose, Dmax,acc
23 8.2 Establishing the sterilization dose, Dster
8.3 Specifying the maximum acceptable dose and the sterilization dose
8.4 Transference of maximum acceptable, verification or sterilization dose between radiation sources
8.4.1 Transference of maximum acceptable dose
24 8.4.2 Transference of verification dose or sterilization dose
9 Validation
9.1 Installation qualification
9.2 Operational qualification
25 9.3 Performance qualification
26 9.4 Review and approval of validation
27 10 Routine monitoring and control
11 Product release from sterilization
28 12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.1.1 General
12.1.2 Frequency of determinations of bioburden
12.1.3 Frequency of sterilization dose audits
30 12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change
31 Annex€A (informative) Guidance
46 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
50 Annex ZB (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
53 Bibliography

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BSI 23/30426672 DC 2023
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