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eLibrary > 23/30426672 DC 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 >

23/30426672 DC 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, 2023

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23/30426672 DC 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, 2023

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

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23/30426672 DC 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, 2023

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