How to Achieve ISO 17664-2:2021 Compliance
SN EN ISO 17664-2:2024
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 2: Nicht kritische Medizinprodukte (ISO 17664-2:2021)
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 (ISO 17664-2:2021)
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). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.
About SN EN ISO 17664-2:2024 at a glance
SN EN ISO 17664-2:2024 is an essential standard published by the International Organization for Standardization (ISO) that delineates the necessary information medical device manufacturers must provide for the processing of non-critical medical devices not intended for sterilization. This document serves as a crucial guideline for ensuring safety and effectiveness in the handling of healthcare products, focusing on the processing instructions, risk analysis, and validation of procedures. The following FAQ answers provide insights into how to achieve ISO 17664-2:2021 compliance, helping manufacturers navigate the complexities of regulatory standards.
Related topics
To further enhance your understanding and implementation of ISO standards, consider exploring the following related areas:
- Other clauses of SN EN ISO 17664-2:2024
- ISO 17664-1:2021, concerning sterilization processes
- Training programs on ISO standards for medical device manufacturers
- CEN and its role in developing European standards for healthcare products
Get the standard or training
For those interested in ensuring compliance, purchasing the SN EN ISO 17664-2:2024 standard or booking training sessions can be invaluable. These resources equip manufacturers with the knowledge necessary to implement effective processing procedures for non-critical medical devices.