Summary

Specifies the general requirements for aseptic processing of health care products. Covers cleanroom design, environmental monitoring, personnel gowning, equipment qualification, process simulation, and other requirements for manufacturing medical devices under aseptic conditions.

Standard Details

Standard Number: ISO 13408-1:2008+AMD1:2013
Type: ISO Standard
Published by: ISO
Official Link: https://www.iso.org/standard/39395.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 13408-1:2008/AMD1:2013 — Aseptic processing of health care products — Part 1: General requirements

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