DIN EN ISO 11137-3:2015-08 (Draft)

Superseded

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Superseded date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

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 552. (07/2006)
DocumentType	Draft
Pages	94
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
Supersedes	DIN EN 552:2001-02

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
DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] (ISO/TS 13004:2013)
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)