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DIN EN ISO 11140-3:2009-09

DIN EN ISO 11140-3:2009-09

Current

Current

The latest, up-to-date edition.

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen
5 Aufbau des Indikatorsystems
6 Leistungsanforderungen
7 Verpackung und Kennzeichnung
8 Qualitätssicherung
Anhang A (normativ) Bestimmung der Festigkeit
          nach der Dampfsterilisation
Anhang B (normativ) Abschätzung des optischen
          Unterschieds zwischen der Farbe des Substrats
          und der des veränderten (oder unveränderten)
          Indikatorsystems durch Bestimmung der relativen
          Reflexionsdichte
Anhang C (normativ) Bestimmung der Farbänderung
          des Indikators bei Einwirkung von trockenem
          gesättigtem Dampf
Anhang D (normativ) Bestimmung der Farbänderung
          des Indikators bei Einwirkung von trockener Hitze
Anhang E (normativ) Alterung von Untersuchungsproben
Anhang F (normativ) Bewertung der Übertragung von
          Indikatorsubstanz auf das Norm-Prüfpaket
          während des Verfahrens
Anhang G (normativ) Bestimmung der Lagerbeständigkeit
          des Produkts
Anhang H (normativ) Dampfsterilisator für Prüfzwecke
Anhang I (normativ) Bestimmung der Empfindlichkeit des
          Indikators gegen die Anwesenheit von Luft
Anhang J (normativ) Luftinjektionssystem
Anhang K (normativ) Norm-Prüfpaket
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG über
          Medizinprodukte

This standard is included in DIN Handbook 265.

DevelopmentNote
Supersedes DIN EN 867-3. (07/2007)
DocumentType
Standard
Pages
30
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
DIN EN ISO 11140-4:2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN HDBK 265 : 2ED 2012 STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE

ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
DIN EN ISO 17665-1:2006-11 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 17665-1:2006)
ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets
ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015 Quality management systems — Requirements
ISO/CIE 10526:1999 CIE standard illuminants for colorimetry
DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
DIN EN 20187:1993-11 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990); German version EN 20187:1993
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
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
DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

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