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Radioactive Medical Devices

Radioactive Medical Devices, Total:314 items.

In the international standard classification, Radioactive Medical Devices involves: Rubber and plastics products, Medical equipment, Radiation protection, Vocabularies, Occupational safety. Industrial hygiene, Pharmaceutics, Radiation measurements, HEALTH CARE TECHNOLOGY, Dentistry, Sterilization and disinfection, Aircraft and space vehicles in general, Electromagnetic compatibility (EMC), Fibre optic communications, Environmental testing, Metrology and measurement in general, Laboratory medicine, Radiocommunications, Safety of machinery, Optoelectronics. Laser equipment, Microbiology.

Association Francaise de Normalisation, Radioactive Medical Devices

NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF EN 45502-2-1:2004 Dispositifs médicaux implantables actifs - Partie 2-1 : règles particulières pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)
NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
NF EN ISO 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques
NF C99-130-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1 : general.
NF EN 50103:2003 Guide pour l'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 à l'industrie des dispositifs médicaux actifs (comprenant les dispositifs actifs implantables)
NF EN ISO 14708-6:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6 : Exigences particulières pour les dispositifs médicaux implantables actifs conçus pour traiter la tachyarythmie (y compris les défibrillateurs implantables)
NF EN ISO 14708-5:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5 : Dispositifs d'assistance circulatoire
NF C74-213:1999 Medical electrical equipment - Part 2-29 : particular requirements for the safety of radiotherapy simulators.
NF EN 61303:1995 Appareils électromédicaux calibrateurs de radionucleides - Méthodes particulières pour décrire les performances
NF C74-214*NF EN 61303:1995 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance.
NF EN ISO 14708-4:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4 : Systèmes de pompe à perfusion implantables
NF S99-110:1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices.
NF C74-207*NF EN 60601-2-9:1997 Medical electrical equipment. Part 2 : particular requiremet for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors.
NF C74-213/A11*NF EN 60601-2-29/A11:2012 Medical electrical equipment - Part 2-29 : particular requirements for the basic safety and essential performance of radiotherapy simulators
NF C74-213*NF EN 60601-2-29:2009 Medical electrical equipment - Part 2-29 : particular requirements for basic safety and essential performance of radiotherapy simulators
NF EN 60601-2-17:2015 Appareils électromédicaux - Partie 2-17 : exigences particulières pour la sécurité de base et les performances essentielles des appareils projecteurs de sources radioactives à chargement différé automatique utilisés en brachythérapie
NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang
NF EN ISO 16637:2019 Radioprotection - Surveillance et dosimétrie interne des travailleurs exposés lors des utilisations médicales des radioéléments en sources non scellées
NF EN 61262-2:1994 Appareils électromédicaux - Caractéristiques des intensificateurs électro-optiques d'image radiologique partie 2 : détermination du facteur de conversion
NF EN 14079:2004 Dispositifs médicaux non actifs - Exigences de performance et méthodes d'essais pour la gaze de coton absorbante et la gaze de coton et viscose absorbante
NF EN 62149-8:2014 Composants et dispositifs actifs à fibres optiques - Norme de performances - Partie 8 : dispositifs amplificateurs optiques à semiconducteur réfléchissants répartis
NF C93-884-8*NF EN 62149-8:2014 Fibre optic active components and devices - Performance standard - Part 8 : seeded reflective semiconductor optical amplifier devices
NF EN 61262-1:1994 Appareils électromédicaux - Caractéristiques des intensificateurs électro-optiques d'image radiologique partie 1 : détermination de la dimension du champ d'entrée
NF EN 13726-3:2003 Dispositifs médicaux non-actifs - Méthodes d'essai pour les pansements primaires en contact avec la plaie - Partie 3 : résistance à la pénétration de l'eau
NF C93-884-9*NF EN 62149-9:2014 Fibre optic active components and devices - Performance standards - Part 9 : seeded reflective semiconductor optical amplifier transceivers
NF EN 61262-5:1994 Appareils électromédicaux - Caractéristiques des intensificateurs électro-optiques d'image radiologique partie 5 : détermination de l'efficacité quantique de détection
NF EN 45502-1:2016 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 1 : exigences générales de sécurité, marquage et informations fournies par le fabricant
NF EN 62149-9:2014 Composants et dispositifs actifs à fibres optiques - Normes de performances - Partie 9 : émetteurs-récepteurs amplificateurs optiques à semiconducteur réfléchissants répartis
NF EN 60601-2-29:2009 Appareils électromédicaux - Partie 2-29 : exigences particulières pour la sécurité de base et les performances essentielles des simulateurs de radiothérapie
NF EN 60601-2-29/A11:2012 Appareils électromédicaux - Partie 2-29 : exigences particulières pour la sécurité de base et les performances essentielles des simulateurs de radiothérapie
NF EN 45502-2-3:2010 Dispositifs médicaux implantables actifs - Partie 2-3 : exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral
NF EN ISO 14708-7:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7 : Exigences particulières pour les systèmes d'implant cochléaire et d'implant auditif du tronc cérébral
NF EN 61262-6:1994 Appareils électromédicaux - Caractéristiques des intensificateurs électro-optiques d'image radiologique partie 6 : détermination du rapport de contraste et du voile lumineux
NF EN 61262-3:1994 Appareils électromédicaux - Caractéristiques des intensificateurs électro-optiques d'image radiologique partie 3 : détermination de la distribution de luminance et de la non-uniformité de luminance
NF S92-021*NF EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
NF EN ISO 15193:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence
NF C74-068*NF EN 60601-2-68:2015 Medical electrical equipment - Part 2-68 : particular requirements for basic safety and essential performance of X-ray based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam the
NF EN ISO 15194:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les échantillons d'origine biologique - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée
NF C99-130-2-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1 : specific assessment for workers with cardiac pacemakers.

German Institute for Standardization, Radioactive Medical Devices

DIN 6846-5:1992 Medical teletherapy systems with gamma-emitting sources; constancy testing
DIN 6846-5:1992-03 Medical teletherapy systems with gamma-emitting sources; constancy testing
DIN 58316:2008 Medical instruments - Abdominal spatulas, malleable
DIN 6855-11:2009 Constancy testing of nuclear medicine instruments - Part 11: Radionuclide calibrators (IEC/TR 61948-4:2006, modified)
DIN 6855-11:2016 Constancy testing of nuclear medicine instruments - Part 11: Radionuclide calibrators (IEC/TR 61948-4:2006, modified)
DIN EN 61303:1996 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance (IEC 61303:1994); German version EN 61303:1995
DIN EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General; German version EN 50527-1:2010
DIN EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators); German version EN 45502-2-2:2008
DIN EN 13726-3:2003-08 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness; German version EN 13726-3:2003 / Note: To be replaced by DIN EN 13726 (2021-02).
DIN EN 13726-4:2003-08 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability; German version EN 13726-4:2003 / Note: To be replaced by DIN EN 13726 (2021-02).
DIN EN 60601-2-29:2009 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008); German version EN 60601-2-29:2008
DIN EN 14079:2003-08 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze; German version EN 14079:2003 / Note: To be replaced by DIN EN 14079 (2004-07), DIN EN 14079-1 (2006-11), DIN EN 14...
DIN 6855-1:2021 Constancy testing of nuclear medical measuring systems - Part 1: Radiation counting systems for measurements in vivo and in vitro
DIN EN 50527-2-1:2012 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers; German version EN 50527-2-1:2011
DIN EN ISO 17511:2019 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019); German and English version prEN ISO 17511:2019
DIN EN 301839-1:2007 Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 1: Technical characterist

Danish Standards Foundation, Radioactive Medical Devices

DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
DS/EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
DS/EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
DS/EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Comformability
DS/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
DS/EN 45502-1:1998 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
DS/EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
DS/EN 60601-2-29/A11:2011 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
DS/EN 60601-2-29:2009 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
DS/EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
DS/ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Lithuanian Standards Office , Radioactive Medical Devices

LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
LST EN 45502-2-2-2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
LST EN 45502-2-2-2008/AC-2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
LST EN 61303-2002 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance (IEC 61303:1994)
LST EN 13726-4-2004 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
LST EN 13726-3-2004 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
LST EN 45502-1-2000 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
LST EN 50527-1-2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General
LST EN 14079-2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
LST EN 60601-2-29-2009/A11-2012 Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
LST EN 60601-2-68-2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam
LST EN 60601-2-29-2009 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)

AENOR, Radioactive Medical Devices

UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE-EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
UNE-EN 61303:1997 MEDICAL ELECTRICAL EQUIPMENT. RADIONUCLEIDE CALIBATORS. PARTICULAR METHODS FOR DESCRIBING PERFORMANCE.
UNE-EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
UNE-EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
UNE-EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General
UNE-EN 14079:2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
UNE-EN 60601-2-29:2009 Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
UNE-EN 60601-2-29:2009/A11:2012 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

European Committee for Standardization (CEN), Radioactive Medical Devices

prEN 724-1992 Guidance on the application of quality systems for the non-active medical device industry
EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
prEN 50103-1992 Guidance on the application of ISO 9001/EN 46001 and ISO 9002/EN 46002 for the active (including active implantable) medical device industry
EN ISO 16637:2019 Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources (ISO 16637:2016)
EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
CEN EN 13726-3-2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
CEN EN 13726-4-2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
EN ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998

国家食品药品监督管理局, Radioactive Medical Devices

YY 0989.6-2016 Surgical implants Active implantable medical devices Part 6: Specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias
YY/T 1465.5-2016 Methods for evaluating the immunogenicity of medical devices Part 5: Determination of α-Gal antigen clearance rate in animal-derived medical devices using M86 antibody
YY/T 1486-2016 Surgical Implants Active Implantable Medical Devices Part 3: Implantable Neurostimulators
YY/T 1623-2018 Test method for effectiveness of sterilization processes for reusable medical devices
YY/T 0972-2016 Dimensions and test requirements for four-pole connector systems for active implantable medical devices and implantable cardiac rhythm regulation devices
YY/T 1561-2017 Detection of residual α-Gal antigen in animal-derived scaffold materials of tissue engineering medical device products
YY 0989.7-2017 Surgical implants Active implantable medical devices Part 7: Specific requirements for cochlear implant systems
YY/T 0771.3-2009 Medical devices utilizing animal tissues and their derivatftives Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy(TSE) agents

British Standards Institution (BSI), Radioactive Medical Devices

21/30421479 DC BS IEC 63322. Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources
23/30475449 DC BS EN IEC 63322. Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources
BS EN 724:1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
BS EN 50527-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - General
BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
PD ISO/TS 10974:2018 Tracked Changes. Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS ISO 16637:2016 Radiological protection. Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources
BS EN 45502-2-2:2008 Active implantable medical devices - Part 2-2:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices
BS EN 60601-2-29:2008+A11:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of radiotherapy simulators
BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
18/30343606 DC BS EN ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BS EN 50527-2-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers
BS EN 60601-2-29:2008 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
BS ISO 16142-1:2016 Tracked Changes. Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...
BS ISO 14117:2013 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
BS EN 1707:1997 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
BS EN 61168:1994 Medical electrical equipment - Particular requirements for performance - Methods of declaring functional performance characteristics of radiotherapy simulators
BS EN 60601-2-68:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equi
BS ISO 27186:2013 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS ISO 27186:2020 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS EN 61676:2002+A1:2009 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS EN 62149-9:2014 Fibre optic active components and devices. Performance standards. Seeded reflective semiconductor optical amplifier transceivers
BS EN 60601-2-31:2008+A1:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2-31+A1:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2-31:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 62149-8:2014 Fibre optic active components and devices. Performance standards. Seeded reflective semiconductor optical amplifier devices
BS EN 61496-3:2001 Safety of machinery - Electro-sensitive protective equipment - Particular requirements for active opto-electronic protective devices responsive to diffuse reflection (AOPDDR)
BS EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS DD CLC/TS 61496-3:2008 Safety of machinery - Electro-sensitive protective equipment - Particular requirements for active opto-electronic protective devices responsive to diffuse reflection (AOPDDR)

BE-NBN, Radioactive Medical Devices

NBN EN 724-1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non- active medical devices
NBN 400-4-1969
NBN 400-3-1969
NBN-HD 395.2.15-1994 Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators

RU-GOST R, Radioactive Medical Devices

GOST 25273-1982 X-ray image intensifier for medical apparatus. Terms and definitions
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 57493-2017 Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases
GOST R 57503-2017 Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases
GOST 30324.2.9-2012 Medical electrical equipment. Part 2-9. Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
GOST R ISO 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
GOST IEC 61303-2011 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
GOST R IEC 61303-1999 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
GOST R 50267.29-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of radiotherapy simulators (imitators)
GOST 30324.2.29-2012 Medical electrical equipment. Part 2-29. Particular requirements for the safety of radiotherapy simulators (imitators)
GOST R 50267.29-1996 Medical electrical equipment. Part 2. Particular requirements for the safety of radiotherapy simulators
GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements
GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems
GOST R 50267.15-1993 Medical electrical equipment. Part 2. Particular requirements for the safaty of capasitor discharge X- ray generators
GOST R 56313-2014 Medical electrical equipment. Generators of radionuclides for production radiopharmpreparations. Technical requirements for governmental purchases
GOST IEC 61676-2011 Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
GOST R 56321-2014 Medical electrical equipment. Medical cyclotrons with energy to 20 MeV for radioactive isotopes. Technical requirements for governmental purchases
GOST R ISO 14708-1-2012 Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be provided by the manufacturer
GOST R 50267.9-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
GOST R 50267.31-1999 Medical electrical equipment. Part 2. Particular requirement for the safety of external cardiac pacemakers with internal power source
GOST R 8.901-2015 State system for ensuring the uniformity of measurements. Instruments of measurement of characteristic of ultraviolet radiation for medical sources. Verification procedure

未注明发布机构, Radioactive Medical Devices

BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN 50103:1996(2000) Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN ISO 15194:2009(2016) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
BS EN 60601-2-9:1997(1999)*BS 5724-2.9:1997 Medical electrical equipment — Part 2 : Particular requirements for safety — Section 2.9 Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors

ES-UNE, Radioactive Medical Devices

UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
UNE-EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
UNE-EN ISO 14708-5:2023 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
UNE-EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
UNE-EN 45502-1:2015 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)
UNE-EN 62149-8:2014 Fibre optic active components and devices - Performance standards - Part 8: Seeded reflective semiconductor optical amplifier devices (Endorsed by AENOR in August of 2014.)
UNE-EN ISO 14708-7:2023 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
UNE-EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide be...
UNE-EN 62149-9:2014 Fibre optic active components and devices - Performance standards - Part 9: Seeded reflective semiconductor optical amplifier transceivers (Endorsed by AENOR in October of 2014.)

International Organization for Standardization (ISO), Radioactive Medical Devices

ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
ISO/CD 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 16637:2016 Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources
ISO 16142-1:2016 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 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
ISO/CD 27186 Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
ISO 27186:2010 Space systems - Programme management - Quality assurance requirements
ISO 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 14708-7:2019 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

US-AAMI, Radioactive Medical Devices

ANSI/AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ANSI/AAMI PC69-2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators

International Electrotechnical Commission (IEC), Radioactive Medical Devices

ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
IEC TR 61948-4:2006 Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
IEC 62467-1:2009 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
IEC 61676:2009 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam
IEC 62149-9:2014 Fibre optic active components and devices - Performance standards - Part 9: Seeded reflective semiconductor optical amplifier transceivers
IEC 62149-8:2014 Fibre optic active components and devices - Performance standard - Part 8: Seeded reflective semiconductor optical amplifier devices
IEC 60601-2-31:2011 Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source

国家药监局, Radioactive Medical Devices

YY/T 0989.5-2022 Surgical implants Active implantable medical devices Part 5: Circulatory support devices
YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

IX-EU/EC, Radioactive Medical Devices

MEDDEV 2.1/1-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)
90/385/EEC-1990 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
NO 722/2012-2012 COMMISSION REGULATION concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal o
95/C 307/09-1995 Commission Communication in the Framework of the Implementation of Council Directive 90/ 385/EEC of 20 June 1990 Concerning Active Implantable Medical Devices and Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices
97/C 149/04-1997 Commission Communication in the Framework of the Implementation of Council Directive 90/385/EEC of 20 June 1990 in Relation to Active Implantable Medical Devices and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices

PL-PKN, Radioactive Medical Devices

PN Z55114-1988 Medical instruments Needles and syringes for injections Rigid conical fittings dimensions
PN-EN ISO 17511-2021-09 E In vitro diagnostic medical devices -- Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2021)

Standard Association of Australia （SAA）, Radioactive Medical Devices

AS/NZS 3200.2.29:2000 Medical electrical equipment - Particular requirements for safety - Radiotherapy simulators
AS/NZS 4354:1995 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
AS EN 45502.1:2002(R2014)
AS/NZS IEC 60601.2.29:2015
AS ISO 14708.1:2015 Implants for surgery — Active implantable medical devices, Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Radioactive Medical Devices

GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

Korean Agency for Technology and Standards (KATS), Radioactive Medical Devices

KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-3-2010(2016) Implants for surgery－Active implantable medical devices－Part 3：Implantable neurostimulators
KS P ISO 14708-3:2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-4-2010(2016) Implants for surgery－Active implantable medical devices－Part 4：Implantable infusion pumps
KS P ISO 14708-5-2012(2017) Implants for surgery－Active implantable medical devices－Part 5：Circulatory support devices
KS C IEC 61303:2018 Medical electrical equipment — Radionuclide calibrators — Particular methods for describing performance
KS P ISO 16142-2:2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 16142-1:2019 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 medic
KS C IEC 60601-2-29:2008 Radiotherapy simulators
KS C IEC 60601-2-29:2017 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
KS P ISO 14708-1:2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
KS C IEC 60601-2-29:2021 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
KS P ISO 17511-2010(2016) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values assigned to calibrators and control materials
KS P ISO 17511:2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
KS C IEC 60601-2-68:2018 Medical electrical equipment ─ Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators,
KS P ISO 18153-2010(2016) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater
KS C IEC 62220-1-1:2020 Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-1: Determination of the detective quantum efficiency — Detectors used in radiographic imaging
KS P ISO 18153-2010(2021) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater
KS C IEC 60601-2-31:2017 Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
KS P ISO 11737-2:2012 Sterilization of medical devices－Microbiological methods－Part 2：Tests of sterility performed in the validation of a sterilization process

KR-KS, Radioactive Medical Devices

KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-3-2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS C IEC 61303-2018 Medical electrical equipment — Radionuclide calibrators — Particular methods for describing performance
KS P ISO 16142-1-2019 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 medic
KS P ISO 16142-2-2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS C IEC 60601-2-29-2017 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
KS P ISO 14708-1-2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
KS C IEC 60601-2-29-2021 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
KS P ISO 17511-2021 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
KS C IEC 60601-2-68-2018 Medical electrical equipment ─ Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators,
KS C IEC 62220-1-1-2020 Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-1: Determination of the detective quantum efficiency — Detectors used in radiographic imaging
KS C IEC 60601-2-31-2017 Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

NZ-SNZ, Radioactive Medical Devices

AS/NZS 4543.1:1999 Protective Medical Devices Against Diagnostic Medical X-Radiation Part 1: Determination of Attenuation Properties of Materials

EU/EC - European Union/Commission Legislative Documents, Radioactive Medical Devices

90/385/EEC CORR-2009 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
MEDDEV 2.1/3-1998 GUIDELINES RELATING TO THE DEMARCATION BETWEEN - DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES - DIRECTIVE 93/42/EEC ON MEDICAL DEVICES AND -DIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTS AND RELATED DIRECTIVES (Rev 5.1)

American National Standards Institute （ANSI), Radioactive Medical Devices

ANSI/AAMI/ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI/AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI N42.17B-1989 Performance Specifications for Health Physics Instrumentation – Occupational Airborne Radioactivity Monitoring Instrumentation

Professional Standard - Medicine, Radioactive Medical Devices

YY 0989.3-2023 Surgical Implants Active Implantable Medical Devices Part 3: Implantable Neurostimulators
YY/T 0879.1-2013 Test for sensitization of medical devices.Part 1:Murine local lymph node assay (LLNA) : Radioisotope incorporation method
YY 9706.268-2022 Medical electrical equipment Part 2-68: X-ray image guides for electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
YY/T 0970-2013 Validation and routine control of sterilization of liquid sterilants for sterilization of single-use medical devices containing materials of animal origin

CENELEC - European Committee for Electrotechnical Standardization, Radioactive Medical Devices

EN 50103:1995 Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the Active (Including Active Implantable) Medical Device Industry

European Committee for Electrotechnical Standardization（CENELEC）, Radioactive Medical Devices

EN 50527-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
HD 395.2.9 S1-1989 Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Dosimeters Used in Radiotherapy with Electrically-Connected Radiation Detectors
EN 62149-8:2014 Fibre optic active components and devices - Performance standards - Part 8: Seeded reflective semiconductor optical amplifier devices
EN 62149-9:2014 Fibre optic active components and devices - Performance standards - Part 9: Seeded reflective semiconductor optical amplifier transceivers
EN 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam
EN 50527-2-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
EN 50527-2-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers

国家质量监督检验检疫总局, Radioactive Medical Devices

SN/T 4508.2-2016 Technical requirements for export medical device inspection Part 2: Disposable syringes (with needle)

CZ-CSN, Radioactive Medical Devices

CSN 40 4318 Za-1987

Professional Standard - Commodity Inspection, Radioactive Medical Devices

SN/T 0323.2-2007 Rules for the inspection of medical equipment for import and export.Part 2:Sterile hypodermic syringes for single use

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Radioactive Medical Devices

GB/T 29083-2012 Safety requirement for flammable material,explosive device,toxic gas and radioactive sources in spacecraft
GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures
GB 16174.1-2015 Implants for surgery.Active implantable medical devices.Part 1:General requirements for safety,marking and for information to be provided by the manufacturer
GB 9706.21-2003 Medical electrical equipment--Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials

国家市场监督管理总局、中国国家标准化管理委员会, Radioactive Medical Devices

GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures

Hebei Provincial Standard of the People's Republic of China, Radioactive Medical Devices

DB13/T 5127.16-2019 Determination of Toxic and Hazardous Substances in Implantable Medical Device Polymer Materials Extraction Bioburden Membrane Filtration Method
DB13/T 5127.9-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices by Ethanol Migration by Gas Chromatography
DB13/T 5127.6-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices by Acetone Migration by Gas Chromatography
DB13/T 5127.7-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices - Lactide Migration by Gas Chromatography
DB13/T 5127.10-2019 Determination of Toxic and Hazardous Substances in Implantable Medical Device Polymer Material Extracts by Gas Chromatography for Migration of Ethylene Oxide
DB13/T 5127.5-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices - Spectrophotometric Method for Migration of Guanidinium Thiocyanate
DB13/T 5127.11-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices with High-performance Liquid Chromatography for Glutaraldehyde Migration
DB13/T 5127.3-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices’ Polymer Materials Part 3: Glucose Migration Iodometric Method
DB13/T 5127.4-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices - Citric Acid Migration Acid-base Neutralization Titration
DB13/T 5127.12-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices - High Performance Liquid Chromatography for Isocyanate Migration
DB13/T 5127.13-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices by Gas Chromatography-Mass Spectrometry
DB13/T 5127.2-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices’ Polymer Materials Part 2: Dimercaptopropanol Migration Iodometric Method
DB13/T 5127.8-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Device Polymer Materials by High Performance Liquid Chromatography for Migration of Terephthalic Acid
DB13/T 5127.14-2019 Determination of Toxic and Hazardous Substances in Extracts of Implantable Medical Devices - Visible-UV Spectrophotometry for Protein Migration

IT-UNI, Radioactive Medical Devices

UNI ISO 21151:2021 In vitro diagnostic medical devices -- Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
UNI EN ISO 17511:2021 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Canadian Standards Association (CSA), Radioactive Medical Devices

CAN/CSA-C22.2 NO.60601-2-29-2010 Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (Third Edition)
CAN/CSA-C22.2 NO.60601-2-68-2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam

Group Standards of the People's Republic of China, Radioactive Medical Devices

T/CSBME 006-2019 Safety Assessment of the Magnetic Resonance Imaging for Active Implantable Medical Device: Method of the Equivalent Tissue-Simulating Medium

CEN - European Committee for Standardization, Radioactive Medical Devices

PREN 14079-2-2006 Non-active medical devices - Properties for compresses and wound packing products for medical use - Part 2: Test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

American Society for Testing and Materials (ASTM), Radioactive Medical Devices

ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)