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)
|