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AAMI 17664 1 2022

AAMI 17664 1 2022

$265.21

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

Published By Publication Date Number of Pages
AAMI 2022 38
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Specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires sterilization or disinfection 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. Applicable for medical devices that are intended for invasive or other direct patient contact or that otherwise present the risk of transmission of infectious agents. Specifies requirements to assist manufacturers of medical devices in providing detailed instructions for processing that consists of the following activities where applicable: pre-treatment at the point of use; preparation, cleaning, disinfection; drying; inspection, maintenance and testing; packaging; sterilization; storage; transportation.

PDF Catalog

PDF Pages PDF Title
1 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
3 Title page
4 AAMI Standard
5 Copyright information
Contents
6 Committee representation
9 Background of ANSI/AAMI adoption of ISO 17664-1:2021
10 Foreword
11 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
20 6.4 Initial treatment at the point of use
6.5 Preparation before cleaning
6.6 Cleaning
6.6.1 General
6.6.2 Automated cleaning
21 6.6.3 Manual cleaning
22 6.7 Disinfection
6.7.1 General
6.7.2 Automated disinfection
6.7.3 Manual disinfection
23 6.8 Drying
6.9 Inspection and maintenance
24 6.10 Packaging
6.11 Sterilization
25 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
32 Table B.1 — Processing instructions (reusable medical devices)
34 Annex C (informative) Classification of medical devices
C.1 General
C.2 Spaulding classification
C.2.1 General
C.2.2 Non-critical items
C.2.3 Semi-critical items
C.2.4 Critical items
35 C.3 Medical device design groups for processing
C.3.1 Key principles
C.3.2 Design considerations
37 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)
38 Bibliography

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AAMI 17664 1 2022
$265.21