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eLibrary > 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 >

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, 2017

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
Objectives and uses of AAMI standards and recommended practices
Title page
AAMI Standard
Copyright information
Contents
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 17664:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified in the information provided by the medical device manufacturer
5 Risk analysis
6 Information to be provided by the medical device manufacturer [Go to Page]
6.1 General
6.2 Processing instructions
6.3 Limitations and restrictions on processing
6.4 Initial treatment at the point of use
6.5 Preparation before cleaning
6.6 Cleaning [Go to Page]
6.6.1 General
6.6.2 Automated cleaning
6.6.3 Manual cleaning
6.7 Disinfection [Go to Page]
6.7.1 General
6.7.2 Automated disinfection
6.7.3 Manual disinfection
6.8 Drying
6.9 Inspection and maintenance
6.10 Packaging
6.11 Sterilization
6.12 Storage
6.13 Transportation
7 Presentation of the information
Annex A (informative) Commonly utilized processing methods [Go to Page]
Table A.1—Processing steps typically performed in a health care facility
Annex B (informative) Example of processing instructions for reusable medical devices
Annex C (informative) Classification of medical devices [Go to Page]
C.1 General
C.2 Spaulding classification
C.3 Medical device design groups for processing [Go to Page]
C.3.1 Key principles
C.3.2 Design considerations
Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer [Go to Page]
D.1 Evaluation of appropriate processing methods (see Clause 6)
D.2 Generic information versus trade names (see 6.1.5)
Bibliography [Go to Page]

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