AAMI 17664 2017
$115.49
ANSI/AAMI/ISO 17664:2017 – Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 37 |
Specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this standard are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this standard. Rather, this standard specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities where applicable: a) Pre-treatment at the point of use before processing; b) Preparation before cleaning; c) Cleaning; d) Disinfection; e) Drying; f) Inspection, maintenance and functionality testing; g) Packaging; h) Sterilization; i) Storage; j) Transportation
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 17664:2017; Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 17664:2017 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope |
| 14 | 2 Normative references 3 Terms and definitions |
| 17 | 4 Validation of the processes identified in the information provided by the medical device manufacturer |
| 18 | 5 Risk analysis 6 Information to be provided by the medical device manufacturer 6.1 General |
| 19 | 6.2 Processing instructions 6.3 Limitations and restrictions on processing 6.4 Initial treatment at the point of use |
| 20 | 6.5 Preparation before cleaning 6.6 Cleaning 6.6.1 General 6.6.2 Automated cleaning |
| 21 | 6.6.3 Manual cleaning 6.7 Disinfection 6.7.1 General 6.7.2 Automated disinfection |
| 22 | 6.7.3 Manual disinfection |
| 23 | 6.8 Drying 6.9 Inspection and maintenance 6.10 Packaging 6.11 Sterilization |
| 24 | 6.12 Storage 6.13 Transportation 7 Presentation of the information |
| 26 | Annex A (informative) Commonly utilized processing methods |
| 27 | Table A.1—Processing steps typically performed in a health care facility |
| 31 | Annex B (informative) Example of processing instructions for reusable medical devices |
| 33 | Annex C (informative) Classification of medical devices C.1 General C.2 Spaulding classification |
| 34 | C.3 Medical device design groups for processing C.3.1 Key principles C.3.2 Design considerations |
| 36 | Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer D.1 Evaluation of appropriate processing methods (see Clause 6) D.2 Generic information versus trade names (see 6.1.5) |
| 37 | Bibliography |
