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AAMI 17664 2 2022

AAMI 17664 2 2022

$265.21

ANSI/AAMI/ISO 17664-2:2022 Processing Of Health Care Products – Information To Be Provided By The Medical Device Manufacturer For The Processing Of Medical Devices – Part 2: Non-Critical Medical Devices

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AAMI 2022
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Specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 17664-2:2022; Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
3 Title page
4 AAMI Standard
5 Copyright information
Contents
6 Committee representation
9 Background of ANSI/AAMI adoption of ISO 17664-2:2021
10 Foreword
11 Introduction
13 1 Scope
14 2 Normative references
3 Terms and definitions
17 4 Risk analysis
18 5 Validation of the processes identified in the information provided by the medical device manufacturer
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 Preparation before processing
6.5 Cleaning
6.5.1 General
6.5.2 Manual cleaning
6.5.3 Automated cleaning
21 6.6 Disinfection
6.6.1 General
6.6.2 Manual disinfection
22 6.6.3 Automated disinfection
6.7 Drying
23 6.8 Inspection and maintenance
6.9 Packaging
6.10 Storage
6.11 Transportation
7 Presentation of the information
24 Annex A (informative) Commonly utilized processing methods
Table A.1 — Processing steps typically performed in a health care facility
29 Annex B (informative) Example processing instructions for non-critical reusable medical devices
30 Table B.1 — Processing instructions (non-critical reusable medical devices)
31 Annex C (informative) Processing classification and grouping of medical devices
C.1 General
C.2 The Spaulding classification
C.2.1 General
C.2.2 Non-critical items
C.2.3 Semi-critical items
C.2.4 Critical items
32 C.3 Medical device design groups for processing
C.3.1 Key principles
C.3.2 Medical device design features
33 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)
34 Annex E (informative) Examples of medical devices and their relationship to this document
35 Figure E.1 — Flow chart to assist with identifying the applicable part of the ISO 17664 series
36 Table E.1 — Examples of medical device types and suggested applicable part of the ISO 17664 series
38 Bibliography

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AAMI 17664 2 2022
$265.21