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AAMI ISO 22442-3:2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
Available format(s)

Hardcopy , PDF

Superseded date

08-05-2020

Language(s)

English

Published date

01-01-2011

Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of
ISO 22442-3:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Literature review
6 Elimination and/or inactivation study
  of viruses and TSE agents
7 Final report
8 Review of final report
9 Routine monitoring and control of
  critical process parameters
Annex A (normative) - Requirements related
        to literature review
Annex B (informative) - Guidance on the
        elimination and/or inactivation study
        for viruses
Annex C (informative) - Guidance on the
        elimination and/or inactivation study
        for TSE agents
Annex D (informative) - Guidance on scaling
        down
Annex E (informative) - Statistical evaluation
        of virus titres and reduction factors and
        assessment of their validity
Annex F (informative) - Calculation of reduction
        factors
Annex G (informative) - Probability of detection
        of agents at low concentrations
Bibliography

Defines requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding invitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable.

DocumentType
Standard
Pages
36
ProductNote
Reconfirmed 2007
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 22442-3:2007 Identical

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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

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