AAMI/ISO 17664-1:2022 PDF

AAMI/ISO 17664-1:2022 PDF

Name:
AAMI/ISO 17664-1:2022 PDF

Published Date:
12/21/2022

Status:
Active

Description:

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

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$72
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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.


ANSI : ANSI Approved
File Size : 1 file , 400 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 38
Published : 12/21/2022

History

AAMI/ISO 17664-1:2022
Published Date: 12/21/2022
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
$72
AAMI/ISO 17664:2017
Published Date: 08/18/2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
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