ANSI/AAMI/ISO 17664-2:2022
Current
The latest, up-to-date edition.
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
English
21-12-2022
This document 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 (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
| DocumentType |
Standard
|
| ISBN |
978-1-57020-864-5
|
| Pages |
38
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ISO 15883-5:2021 | Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| IEC 62366-1:2015+AMD1:2020 CSV | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO 15883-6:2011 | Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment |
| ISO 15883-3:2006 | Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers |
| ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer |
| ISO 15883-4:2018 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
| ASTM D 8179 : 2018 | Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices |
| AAMI TIR30:2011(R2016) | A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
| ISO 17664-1:2021 | 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 |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| AAMI TIR12:2020(R2023) | Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| ISO 15883-7:2016 | Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
| ISO 15883-2:2006 | Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
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