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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 (ISO 22442-3:2007)
Published date

12-15-2007

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

ISO 22442-3:2007 specifies 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. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

Committee
CEN/TC 206
DevelopmentNote
Supersedes EN 12442-3. (02/2008)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Application of risk management
I.S. EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)

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
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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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