DIN EN ISO 11140-3:2009-09
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
Hardcopy , PDF
English
01-01-2009
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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 |
| Standards | Relationship |
| ISO 11140-3:2007 | Identical |
| NF EN ISO 11140-3 : 2009 | Identical |
| NBN EN ISO 11140-3 : 2009 | Identical |
| NEN EN ISO 11140-3 : 2009 | Identical |
| NS EN ISO 11140-3 : 2009 | Identical |
| I.S. EN ISO 11140-3:2009 | Identical |
| SN EN ISO 11140-3:2009 | Identical |
| UNI EN ISO 11140-3 : 2009 | Identical |
| UNE-EN ISO 11140-3:2009 | Identical |
| BS EN ISO 11140-3:2009 | Identical |
| EN ISO 11140-3:2009 | Identical |
| 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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