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BS EN ISO 17664-2:2023:2024 Edition

BS EN ISO 17664-2:2023:2024 Edition

$167.15

Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Non-critical medical devices

Published By Publication Date Number of Pages
BSI 2024 38
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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 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 Foreword
11 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
16 4 Risk analysis
17 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
18 6.2 Processing instructions
19 6.3 Limitations and restrictions on processing
6.4 Preparation before processing
6.5 Cleaning
6.5.1 General
6.5.2 Manual cleaning
20 6.5.3 Automated cleaning
6.6 Disinfection
6.6.1 General
6.6.2 Manual disinfection
21 6.6.3 Automated disinfection
6.7 Drying
6.8 Inspection and maintenance
22 6.9 Packaging
6.10 Storage
6.11 Transportation
7 Presentation of the information
23 Annex A (informative) Commonly utilized processing methods
27 Annex B (informative) Example processing instructions for non-critical reusable medical devices
29 Annex C (informative) Processing classification and grouping of medical devices
31 Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer
32 Annex E (informative) Examples of medical devices and their relationship to this document
36 Bibliography

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BS EN ISO 17664-2:2023
$167.15