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.<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4 Risk analysis <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6.2 Processing instructions <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.3 Limitations and restrictions on processing 6.4 Preparation before processing 6.5 Cleaning 6.5.1 General 6.5.2 Manual cleaning <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6.5.3 Automated cleaning 6.6 Disinfection 6.6.1 General 6.6.2 Manual disinfection <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6.6.3 Automated disinfection 6.7 Drying 6.8 Inspection and maintenance <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6.9 Packaging 6.10 Storage 6.11 Transportation 7 Presentation of the information <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Annex A (informative) Commonly utilized processing methods <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Annex B (informative) Example processing instructions for non-critical reusable medical devices <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex C (informative) Processing classification and grouping of medical devices <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex E (informative) Examples of medical devices and their relationship to this document <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Non-critical medical devices<\/b><\/p>\n |