DIN EN ISO 11137-3:2015-08 (Draft)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
Available format(s)
Hardcopy , PDF
Superseded date
07-03-2021
Language(s)
German
Published date
01-01-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.| DevelopmentNote |
Supersedes DIN EN 552. (07/2006)
|
| DocumentType |
Draft
|
| Pages |
94
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11137-3 : 2017 | Identical |
| NBN EN ISO 11137-3 : 2006 | Identical |
| NEN EN ISO 11137-3 : 2017 | Identical |
| NS EN ISO 11137-3 : 2017 | Identical |
| I.S. EN ISO 11137-3:2017 | Identical |
| UNI EN ISO 11137-3 : 2006 | Identical |
| UNE-EN ISO 11137-3:2007 | Identical |
| BS EN ISO 11137-3:2017 | Identical |
| EN ISO 11137-3:2017 | Identical |
| ISO 11137-3:2017 | Identical |
| SN EN ISO 11137-3 : 2017 | Identical |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 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 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN HDBK 263 : 4ED 2014 | |
| DIN HDBK 268 : 3ED 2015 | NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| 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) |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| 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 |
| DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014 |
| ISO/ASTM 51401:2013 | Practice for use of a dichromate dosimetry system |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO/ASTM 51650:2013 | Practice for use of a cellulose triacetate dosimetry system |
| ISO 11462-2:2010 | Guidelines for implementation of statistical process control (SPC) — Part 2: Catalogue of tools and techniques |
| ISO/ASTM 51276:2012 | Practice for use of a polymethylmethacrylate dosimetry system |
| ISO/ASTM 52303:2015 | Guide for absorbed-dose mapping in radiation processing facilities |
| ISO/ASTM 51818:2013 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
| ISO/ASTM 51261:2013 | Practice for calibration of routine dosimetry systems for radiation processing |
| DIN EN ISO 14253-1:2013-12 | GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - INSPECTION BY MEASUREMENT OF WORKPIECES AND MEASURING EQUIPMENT - PART 1: DECISION RULES FOR PROVING CONFORMITY OR NONCONFORMITY WITH SPECIFICATIONS (ISO 14253-1:2013) |
| ISO 14253-1:2017 | Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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/ASTM 51275:2013 | Practice for use of a radiochromic film dosimetry system |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| ISO/ASTM 51608:2015 | Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV |
| ASTM E 2232 : 2016 : REDLINE | Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications |
| ISO/ASTM 52701:2013 | Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| DIN EN ISO 14253-2:2011-11 | GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - INSPECTION BY MEASUREMENT OF WORKPIECES AND MEASURING EQUIPMENT - PART 2: GUIDANCE FOR THE ESTIMATION OF UNCERTAINTY IN GPS MEASUREMENT, IN CALIBRATION OF MEASURING EQUIPMENT AND IN PRODUCT VERIFICATION (ISO 14253-2:2011) |
| ISO/ASTM 51607:2013 | Practice for use of the alanine-EPR dosimetry system |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO/ASTM 51649:2015 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
| ISO/ASTM 51707:2015 | Guide for estimation of measurement uncertainty in dosimetry for radiation processing |
| ISO/ASTM 52628:2013 | Standard practice for dosimetry in radiation processing |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO/ASTM 51631:2013 | Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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