ISO/TS 13004:2013
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Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
ISO/IEC 17000:2004
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Conformity assessment Vocabulary and general principles |
CLSI MM3 A3 : 3ED 2015
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MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
ISO 15195:2003
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Laboratory medicine Requirements for reference measurement laboratories |
ISO 15194:2009
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In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
ISO 22870:2016
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Point-of-care testing (POCT) — Requirements for quality and competence |
ISO/TR 24971:2013
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Medical devices Guidance on the application of ISO 14971 |
IEC TR 80001-2-5:2014
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Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
EN 13641:2002
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Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
IEC 61326-2-6:2012
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
CLSI POCT4 A2 : 2ED 2006
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POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING |
EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES |
IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
CLSI MM16 A : 1ED 2006
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USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS |
ISO 15193:2009
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In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
CLSI MM6 A2 : 2ED 2010
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QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
CLSI EP5 A3 : 3ED 2014
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Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
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CLSI MM9 A2 : 2ED 2014
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NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
CLSI MM17 A : 1ED 2008
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VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
ISO 31000:2009
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Risk management Principles and guidelines |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
CLSI EP26 A : 1ED 2013
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USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION |
EN 14136:2004
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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
ISO 16142-1:2016
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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
CLSI EP12 A2 : 2ED 2008
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USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
ISO 25424:2009
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Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
CLSI EP6 A : 1ED 2003
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EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
ISO/TS 19218-1:2011
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Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
ISO 18153:2003
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In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
ISO/IEC Guide 63:2012
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Guide to the development and inclusion of safety aspects in International Standards for medical devices |
ASTM F 2027 : 2016 : REDLINE
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Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
CLSI I/LA18 A2 : 2ED 2001
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SPECIFICATIONS FOR IMMUNOLOGICAL TESTING FOR INFECTIOUS DISEASES |
CLSI MM22 A : 1ED 2014
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MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
ISO 23640:2011
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In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
ISO 17511:2003
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In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice |
ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
ASTM F 2761 : 2009 : R2013
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Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
ISO 16256:2012
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Clinical laboratory testing and in vitro diagnostic test systems Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases |
ISO 14001:2015
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Environmental management systems — Requirements with guidance for use |
EN 13532:2002
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General requirements for in vitro diagnostic medical devices for self-testing |
CLSI POCT12 A3 : 3ED 2013
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Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition
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ISO 9001:2015
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Quality management systems — Requirements |
IEC 62471:2006
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Photobiological safety of lamps and lamp systems |
ISO 17593:2007
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Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
ISO/IEC Guide 2:2004
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Standardization and related activities General vocabulary |
CLSI MM12 A : 1ED 2006
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DIAGNOSTIC NUCLEIC ACID MICROARRAYS |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
IEC TR 80001-2-1:2012
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Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
ISO 15197:2013
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In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
IEC 60601-1-9:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
CLSI M53 A : 1ED 2011
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CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION |
IEC 60799:1998
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Electrical accessories - Cord sets and interconnection cord sets |