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eLibrary > BS EN ISO 17664-2:2023 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Non-critical medical devices >

BS EN ISO 17664-2:2023 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Non-critical medical devices, 2024

undefined [Go to Page]
Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk analysis
5 Validation of the processes identified in the information provided by the medical device manufacturer
6 Information to be provided by the medical device manufacturer
6.1 General
6.2 Processing instructions
6.3 Limitations and restrictions on processing
6.4 Preparation before processing
6.5 Cleaning
6.5.1 General
6.5.2 Manual cleaning
6.5.3 Automated cleaning
6.6 Disinfection
6.6.1 General
6.6.2 Manual disinfection
6.6.3 Automated disinfection
6.7 Drying
6.8 Inspection and maintenance
6.9 Packaging
6.10 Storage
6.11 Transportation
7 Presentation of the information
Annex A (informative) Commonly utilized processing methods
Annex B (informative) Example processing instructions for non-critical reusable medical devices
Annex C (informative) Processing classification and grouping of medical devices
Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer
Annex E (informative) Examples of medical devices and their relationship to this document
Bibliography [Go to Page]

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