This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.<\/p>\n
The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.<\/p>\n<\/div>\n
This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.<\/p>\n<\/div>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 4 Performance requirements 4.1 General 4.2 Test soil considerations <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4.3 Load considerations <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.4 Cleaning efficacy test criteria 4.4.1 General 4.4.2 Visual examination 4.4.3 Assay criteria <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.4.4 Process residuals 5 Testing for conformity 5.1 Cleaning test method validation 5.1.1 General 5.1.2 Load soiling method 5.1.3 Detection method(s) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.1.4 Analyte assay method 5.2 Washer-disinfector requirements 5.3 Cleaning type test 5.3.1 Principle 5.3.2 Reagents\/materials 5.3.3 Procedure 5.3.4 Acceptance criteria <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.4 Cleaning performance qualification test 5.4.1 Principle 5.4.2 Reagents\/materials 5.4.3 Procedure 5.4.4 Acceptance criteria 5.5 Process residuals 5.5.1 General <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.5.2 Risk analysis 5.5.3 Cytotoxicity 5.5.4 Sampling methods 5.5.5 Acceptance criteria <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | Annex A (informative) Examples of test soils <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex B (normative) Protein-based test soil performance assessment <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Annex C (informative) Examples of test methods for the detection and assessment of residual proteinaceous contamination <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Annex D (informative) Examples of test methods for the detection of haemoglobin for the assessment of cleaning efficacy <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Annex E (informative) Test soil performance assessment \u2013 Sample results sheets <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Washer-disinfectors – Performance requirements and test method criteria for demonstrating cleaning efficacy<\/b><\/p>\n |