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DIN EN ISO 22442-3:2008-03

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

01-01-2008

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen
  4.1 Risikomanagement
  4.2 Verfahren der Beschaffung und Herstellung
  4.3 Allgemeine Anforderungen in Bezug auf
      die Validierung
      4.3.1 Dokumentierte Verfahren
      4.3.2 Personal
      4.3.3 Kalibrierung
      4.3.4 Ausrüstung
      4.3.5 Experimentelle Systeme
5 Literaturrecherche
  5.1 Durchführung der Literaturrecherche
  5.2 Anwendung der Ergebnisse der Literaturrecherche
  5.3 Viren
  5.4 Infektiöse TSE-Materialien
6 Eliminierungs- und/oder Inaktivierungsstudie für
  Viren und infektiöses TSE-Material
  6.1 Allgemeines
  6.2 Prüfplan
  6.3 Durchführung der Studie
  6.4 Auswertung der Daten
7 Abschlussbericht
8 Überprüfung des Abschlussberichtes
9 Routineüberwachung und Kontrolle von
  kritischen Prozessparametern
Anhang A (normativ) Anforderungen an die Literaturrecherche
                      und -bewertung
      A.1 Allgemeines
          A.1.1 Methodik
          A.1.2 Kritische Bewer
      A.2 Schlussfolgerungen
      A.3 Bericht
Anhang B (informativ) Anleitung zur Eliminierungs- und/oder
                       Inaktivierungsstudie für Viren
      B.1 Allgemeines
      B.2 Auswahl der Viren
      B.3 Design und Umsetzung von Eliminierungs- und/oder
          Inaktivierungsstudien
          B.3.1 Allgemeines
          B.3.2 Design der Studie
          B.3.3 Kultivierung von Modellviren
          B.3.4 Durchführung von Prüfungen mit Zellkulturen
          B.3.5 Reduktionsfaktoren
      B.4 Grenzen der Eliminierungs- und/oder
          Inaktivierungsstudien
Anhang C (informativ) Anleitung zur Eliminierungs- und/oder
                       Inaktivierungsstudie für
                       infektiöse TSE-Materialien
      C.1 Allgemeines
      C.2 Infektiöse TSE-Materialien, die nicht vom
          Inaktivierungsschritt erfasst wurden
Anhang D (informativ) Anleitung zur Einrichtung eines
                       Verfahrens in massstabsgerechter
                       Verkleinerung (scaling down)
Anhang E (informativ) Statistische Auswertung der Virustiter
                       und Reduktionsfaktoren und Bewertung
                       von deren Validität
Anhang F (informativ) Berechnung von Reduktionsfaktoren
Anhang G (informativ) Nachweiswahrscheinlichkeit von
                       Erregern bei geringen Konzentrationen
Anhang ZA (informativ) Zusammenhang zwischen dieser
                       Europäischen Norm und den
                       grundlegenden Anforderungen der
                       durch die Richtlinie der Kommission
                       2003/32/EG geänderten EG-Richtlinie
                       93/42/EWG über Medizinprodukte
Literaturhinweise

This standard is included in DIN Handbook 406. Describes 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.

DevelopmentNote
Supersedes DIN EN 12442-3. (03/2008)
DocumentType
Standard
Pages
29
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
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)
DIN HDBK 406 : 2ED 2016
DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 14160:2011-10 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 14160:2011)
DIN EN ISO 11137-1:2015-11 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)

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
DIN EN ISO 22442-2:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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
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)

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