Name: AAMI ISO 13408-2 : 2003 : R2013
Brand: AAMI

AAMI ISO 13408-2 : 2003 : R2013

Superseded

View Superseded by

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION

Available format(s)

Hardcopy , PDF

Superseded date

01-25-2020

Language(s)

English

Published date

01-01-2013

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 13408-2:2018
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Sterilizing filter characterization
6 Process and equipment characterization
7 Fluid definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilizing filtration
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the
application Annex A of this document
Bibliography

Describes requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1.

DocumentType	Standard
Pages	25
ProductNote	Reconfirmed 2013
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI/ISO 13408-2:2018
Supersedes	AAMI ISO 13408-2 : 2003

Standards	Relationship
ISO 13408-2:2003	Identical

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 13408-7:2012	Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 13408-3:2006	Aseptic processing of health care products Part 3: Lyophilization
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-6:2005	Aseptic processing of health care products Part 6: Isolator systems
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 13408-5:2006	Aseptic processing of health care products Part 5: Sterilization in place