Environmental monitoring for terminally sterilized healthcare products

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-31-2022

Publisher

Association for the Advancement of Medical Instrumentation

This technical report addresses routine monitoring for viable (i.e. microorganisms) and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.

DocumentType	Standard
ISBN	978-1-57020-515-6
Pages	23
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI TIR52 : 2014(R2017)

ISO 14971:2019	Medical devices Application of risk management to medical devices
ISO 14644-6:2007	Cleanrooms and associated controlled environments Part 6: Vocabulary
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 8573-1:2010	Compressed air Part 1: Contaminants and purity classes
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 14644-7:2004	Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-3:2019	Cleanrooms and associated controlled environments Part 3: Test methods
ISO 14644-4:2022	Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 11737-1:2018	Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products