BS EN ISO 25424:2019+A1:2022
$198.66
Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 60 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | 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 ZA (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered |
| 10 | Annex ZB (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 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 |
| 15 | Foreword |
| 16 | Introduction |
| 19 | 1 Scope 1.1 Inclusions 1.2 Exclusions |
| 20 | 2 Normative references 3 Terms and definitions |
| 26 | 4 Quality management system elements 4.1 General 4.2 Documentation 4.3 Management responsibility |
| 27 | 4.4 Product realization 4.5 Control of non-conforming product 5 Sterilizing agent characterization 5.1 General 5.2 Sterilizing agent 5.3 Microbicidal effectiveness |
| 28 | 5.4 Material effects 5.5 Environmental considerations 6 Process and equipment characterization 6.1 General 6.2 Process |
| 29 | 6.3 Equipment 7 Product definition |
| 30 | 8 Process definition |
| 31 | 9 Validation 9.1 General |
| 32 | 9.2 Installation qualification 9.2.1 General 9.2.2 Installation 9.2.3 Equipment |
| 33 | 9.3 Operational qualification 9.4 Performance qualification 9.4.1 General |
| 34 | 9.4.2 Performance qualification — Physical 9.4.3 Performance qualification — Microbiological |
| 35 | 9.4.4 Performance qualification — Desorption and drying 9.5 Review and approval of validation |
| 36 | 10 Routine monitoring and control 10.1 General 10.2 Biological indicators 10.3 Chemical indicators 10.4 Records |
| 37 | 11 Product release from sterilization 12 Maintaining process effectiveness 12.1 General 12.2 Maintenance of equipment 12.3 Requalification |
| 38 | 12.4 Assessment of change |
| 39 | Annex A (normative) Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized |
| 40 | Annex B (normative) Process definition based on inactivation of reference microorganisms |
| 43 | Annex C (informative) Guidance on application of this document |
| 53 | Annex D (informative) Environmental aspects regarding development, validation and routine control of low temperature steam and formaldehyde processes |
| 58 | Bibliography |
