DIN EN ISO 22442-3:2008-03
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
Hardcopy , PDF
English
01-01-2008
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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 |
| Standards | Relationship |
| ISO 22442-3:2007 | Identical |
| EN ISO 22442-3:2007 | Identical |
| SN EN ISO 22442-3:2008 | Identical |
| NS EN ISO 22442-3 : 1ED 2007 | Identical |
| NBN EN ISO 22442-3 : 2008 | Identical |
| NEN EN ISO 22442-3 : 2008 | Identical |
| NF EN ISO 22442-3 : 2008 | Identical |
| BS EN ISO 22442-3:2007 | Identical |
| I.S. EN ISO 22442-3:2007 | Identical |
| 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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