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I.S. EN ISO 22442-3:2007

I.S. EN ISO 22442-3:2007

Current

Current

The latest, up-to-date edition.

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

Language(s)

English

Published date

01-01-2007

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
  4.1 Risk management
  4.2 Sourcing and manufacturing process
  4.3 General requirements related to validation
5 Literature review
  5.1 Conduct of the literature review
  5.2 Application of literature review output
  5.3 Viruses
  5.4 TSE agents
6 Elimination and/or inactivation study of viruses and TSE
  agents
  6.1 General
  6.2 Protocol
  6.3 Conduct of the study
  6.4 Interpretation of data
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
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of Directive 93/42/EEC as amended by
                       Commission Directive 2003/32/EC
Bibliography

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

Committee
TC 194
DevelopmentNote
Supersedes I.S. EN 12442-3. (02/2008)
DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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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