DIN EN ISO 11140-1:2015-03
Current
Current
The latest, up-to-date edition.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
Available format(s)
Hardcopy , PDF
Language(s)
German, English
Published date
01-03-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.| DevelopmentNote |
Supersedes DIN EN 867-1, DIN EN 867-2. (04/2006)
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| DocumentType |
Standard
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| Pages |
42
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| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| ISO 11140-1:2014 | Identical |
| NF EN ISO 11140-1 : 2015 | Identical |
| NBN EN ISO 11140-1 : 2014 | Identical |
| NEN EN ISO 11140-1 : 2014 | Identical |
| NS EN ISO 11140-1 : 2014 | Identical |
| I.S. EN ISO 11140-1:2014 | Identical |
| SN EN ISO 11140-1:2015 | Identical |
| UNI EN ISO 11140-1 : 2009 | Identical |
| UNE-EN ISO 11140-1:2015 | Identical |
| BS EN ISO 11140-1:2014 | Identical |
| EN ISO 11140-1:2014 | 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 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) |
| DIN EN ISO 11140-3:2009-09 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| 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 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN EN ISO 9687:2015-05 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015) |
| DIN HDBK 265 : 2ED 2012 | STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| DIN ISO 8601:2006-09 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| ISO/IEC 17050-1:2004 | Conformity assessment Supplier's declaration of conformity Part 1: General requirements |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| DIN EN ISO/IEC 17050-1:2010-08 | Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15); German and English version EN ISO/IEC 17050-1:2010 |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| 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 |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 11140-3:2007 | Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| DIN EN ISO 14161:2010-03 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 11140-4:2007 | 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 |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 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) |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| DIN EN ISO 11140-3:2009-09 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST |
| ISO 9001:2015 | Quality management systems — Requirements |
| DIN EN ISO 18472:2006-10 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| ISO 11140-5:2007 | Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 11138-4:2017 | Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN 13060:2014 | Small steam sterilizers |
| 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 |
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