ISO/TS 13004:2013
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Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
IEC 80001-1:2010
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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
ISO 14408:2016
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Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information |
ISO 9168:2009
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Dentistry Hose connectors for air driven dental handpieces |
IEC TR 80002-1:2009
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Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
IEC 61168:1993
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Radiotherapy simulators - Functional performance characteristics |
ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs |
ISO 5364:2016
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Anaesthetic and respiratory equipment — Oropharyngeal airways |
IEC 60336:2005
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Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
ISO 5360:2016
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Anaesthetic vaporizers Agent-specific filling systems |
ISO 8827:1988
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Implants for surgery Staples with parallel legs for orthopaedic use General requirements |
ISO 690:2010
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Information and documentation Guidelines for bibliographic references and citations to information resources |
ISO 7376:2009
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Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation |
ISO 21649:2006
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Needle-free injectors for medical use — Requirements and test methods |
ISO/TR 24971:2013
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Medical devices Guidance on the application of ISO 14971 |
ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
ISO 15002:2008
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Flow-metering devices for connection to terminal units of medical gas pipeline systems |
ISO 8537:2016
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Sterile single-use syringes, with or without needle, for insulin |
IEC 60731:2011+AMD1:2016 CSV
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Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
ISO 11663:2014
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Quality of dialysis fluid for haemodialysis and related therapies |
ISO 21534:2007
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Non-active surgical implants Joint replacement implants Particular requirements |
IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
ISO 22523:2006
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External limb prostheses and external orthoses — Requirements and test methods |
ISO 7198:2016
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Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
IEC 61674:2012
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Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
IEC TR 62266:2002
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Medical electrical equipment - Guidelines for implementation of DICOM in radiotherapy |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ASTM F 2212 : 2011 : REDLINE
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
IEC 61689:2013
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Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
ISO 9626:2016
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Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
IEC 61846:1998
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Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
ISO 8637:2010
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Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 23747:2015
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Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
ISO 15001:2010
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Anaesthetic and respiratory equipment Compatibility with oxygen |
IEC 60522:1999
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Determination of the permanent filtration of X-ray tube assemblies |
IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
ISO 8638:2010
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Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 19054:2005
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Rail systems for supporting medical equipment |
ISO 9713:2002
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Neurosurgical implants Self-closing intracranial aneurysm clips |
IEC 61910-1:2014
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Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
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 |
IEC 60976:2007
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Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
IEC 61847:1998
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Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
ISO 8835-7:2011
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Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
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 |
ISO 13958:2014
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Concentrates for haemodialysis and related therapies |
ISO 7405:2008
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Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
ISO 18777:2005
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Transportable liquid oxygen systems for medical use — Particular requirements |
ISO 21536:2007
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Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
ISO/TS 19218-1:2011
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Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
ISO 21969:2009
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High-pressure flexible connections for use with medical gas systems |
IEC 62083:2009
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Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
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 |
ISO 14630:2012
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Non-active surgical implants General requirements |
ISO 14457:2017
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Dentistry — Handpieces and motors |
ISO 5367:2014
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Anaesthetic and respiratory equipment — Breathing sets and connectors |
ISO 9584:1993
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Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
IEC 62563-1:2009+AMD1:2016 CSV
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Medical electrical equipment - Medical image display systems - Part1: Evaluation methods |
IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
ISO 5359:2014
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Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases |
ISO 5362:2006
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Anaesthetic reservoir bags |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
ISO 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
ISO 18778:2005
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Respiratory equipment — Infant monitors — Particular requirements |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
ISO 14602:2010
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Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
ISO 6474-1:2010
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Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
ISO 11197:2016
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Medical supply units |
ISO 3107:2011
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Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements |
ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements |
IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice |
ISO 9583:1993
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Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants |
IEC 60580:2000
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Medical electrical equipment - Dose area product meters |
ISO 7199:2016
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Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators) |
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 |
ISO 15985:2014
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Plastics — Determination of the ultimate anaerobic biodegradation under high-solids anaerobic-digestion conditions — Method by analysis of released biogas |
ISO 26722:2014
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Water treatment equipment for haemodialysis applications and related therapies |
ISO 22612:2005
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Clothing for protection against infectious agents Test method for resistance to dry microbial penetration |
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 |
IEC 60601-1-3:2008+AMD1:2013 CSV
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Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
ISO 7864:2016
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Sterile hypodermic needles for single use — Requirements and test methods |
ISO 22610:2006
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Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration |
IEC 60118-15:2012
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Electroacoustics - Hearing aids - Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal |
ISO 23500:2014
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Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
ISO 27186:2010
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Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
IEC 61223-3-4:2000
|
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
ISO 13959:2014
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Water for haemodialysis and related therapies |
IEC 61223-2-6:2006
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Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
IEC 62471:2006
|
Photobiological safety of lamps and lamp systems |
ISO 7153-1:2016
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Surgical instruments Materials Part 1: Metals |
ISO 17510:2015
|
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
IEC 60627:2013
|
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
IEC 61217:2011
|
Radiotherapy equipment - Coordinates, movements and scales |
ISO 5361:2016
|
Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
ISO 14879-1:2000
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Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays |
ISO 8828:2014
|
Implants for surgery Guidance on care and handling of orthopaedic implants |
ISO 13402:1995
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Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure |
IEC 61676:2002+AMD1:2008 CSV
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Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
ISO 23908:2011
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Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
ISO 7197:2006
|
Neurosurgical implants Sterile, single-use hydrocephalus shunts and components |
IEC 62494-1:2008
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Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO 7000:2014
|
Graphical symbols for use on equipment Registered symbols |
IEC 61303:1994
|
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance |
AAMI TIR49 : 2013
|
DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS |
IEC 62359:2010+AMD1:2017 CSV
|
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
ISO 13782:1996
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Implants for surgery Metallic materials Unalloyed tantalum for surgical implant applications |
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
IEC TR 80001-2-1:2012
|
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 23907:2012
|
Sharps injury protection Requirements and test methods Sharps containers |
IEC 60601-1-9:2007+AMD1:2013 CSV
|
Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
ISO 14607:2007
|
Non-active surgical implants Mammary implants Particular requirements |
ISO 22675:2016
|
Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods |
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
ISO 11318:2002
|
Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
ISO 21535:2007
|
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |