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ANSI/AAMI/ISO 17664-1:2022 Processing Of Health Care Products -Information To Be Provided By The Medical Device Manufacturer For The Processing Of Medical Devices - Part 1: Critical And Semi-Critical Medical Devices >
ANSI/AAMI/ISO 17664-1:2022 Processing Of Health Care Products -Information To Be Provided By The Medical Device Manufacturer For The Processing Of Medical Devices - Part 1: Critical And Semi-Critical Medical Devices, 2022
- ANSI/AAMI/ISO 17664-1:2022; Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Background of ANSI/AAMI adoption of ISO 17664-1:2021
- 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]
- 7 Presentation of the information
- Annex A (informative) Commonly utilized processing methods [Go to Page]
- Annex B (informative) Example of processing instructions for reusable medical devices [Go to Page]
- Annex C (informative) Classification of medical devices
- C.1 General
- C.2 Spaulding classification [Go to Page]
- C.3 Medical device design groups for processing [Go to Page]
- Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer [Go to Page]
- Bibliography [Go to Page]
