11.040 : Medical equipment 11 : Health care technology ICS, Published by: AENOR

UNE-EN ISO 27427:2024

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
3/20/2024 - PDF - Spanish - AENOR
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€89.00

UNE-EN ISO 27427:2024

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
3/20/2024 - PDF - English - AENOR
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€106.80

Optics and optical instruments - Test lenses for calibration of focimeters - Part 1: Reference lenses for focimeters used for measuring spectacle lenses (ISO 9342-1:2023)
3/6/2024 - PDF - Spanish - AENOR
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€74.00

UNE-EN ISO 9342-1:2024

Optics and optical instruments - Test lenses for calibration of focimeters - Part 1: Reference lenses for focimeters used for measuring spectacle lenses (ISO 9342-1:2023)
3/6/2024 - PDF - English - AENOR
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€88.80

UNE-EN ISO 24072:2024

Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)
1/24/2024 - PDF - Spanish - AENOR
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€60.00

UNE-EN ISO 24072:2024

Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)
1/24/2024 - PDF - English - AENOR
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€72.00

UNE-EN ISO 19979:2024

Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)
1/24/2024 - PDF - Spanish - AENOR
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€60.00

UNE-EN ISO 19979:2024

Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)
1/24/2024 - PDF - English - AENOR
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€72.00

UNE-EN ISO 10651-4:2023

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
11/15/2023 - PDF - Spanish - AENOR
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€126.00

UNE-EN ISO 10651-4:2023

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
11/15/2023 - PDF - English - AENOR
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€151.20

UNE-EN IEC 60601-2-76:2019/A1:2023

Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in November of 2023.)
11/3/2023 - PDF - English - AENOR
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€35.00

UNE-EN ISO 3826-1:2020/A1:2023

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
10/25/2023 - PDF - Spanish - AENOR
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€34.00

UNE-EN ISO 3826-1:2020/A1:2023

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
10/25/2023 - PDF - English - AENOR
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€40.80

UNE-EN IEC 62220-2-1:2023

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging (Endorsed by Asociación Española de Normalización in October of 2023.)
10/6/2023 - PDF - English - AENOR
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€69.00

UNE-EN ISO 21649:2023

Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
10/4/2023 - PDF - Spanish - AENOR
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€95.00

UNE-EN ISO 21649:2023

Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
10/4/2023 - PDF - English - AENOR
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€114.00

UNE-EN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
10/4/2023 - PDF - Spanish - AENOR
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€73.00

UNE-EN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
10/4/2023 - PDF - English - AENOR
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€87.60

UNE-EN IEC 61010-2-101:2023

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
9/27/2023 - PDF - Spanish - AENOR
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€68.00

UNE-EN IEC 61010-2-101:2023

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
9/27/2023 - PDF - English - AENOR
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€81.60

UNE-EN IEC 61010-2-101:2023/A11:2023

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
9/27/2023 - PDF - Spanish - AENOR
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€68.00

UNE-EN IEC 61010-2-101:2023/A11:2023

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
9/27/2023 - PDF - English - AENOR
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€81.60

UNE-EN ISO 5361:2023

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)
9/20/2023 - PDF - Spanish - AENOR
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€101.00

UNE-EN ISO 5361:2023

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)
9/20/2023 - PDF - English - AENOR
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€121.20

UNE-EN ISO 21917:2023

Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
9/20/2023 - PDF - Spanish - AENOR
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€68.00

UNE-EN ISO 21917:2023

Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
9/20/2023 - PDF - English - AENOR
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€81.60

UNE-EN ISO 81060-3:2023

Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
9/20/2023 - PDF - Spanish - AENOR
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€96.00

UNE-EN ISO 81060-3:2023

Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
9/20/2023 - PDF - English - AENOR
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€115.20

UNE-EN ISO 80601-2-72:2023

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023) (Endorsed by Asociación Española de Normalización in August of 2023.)
8/2/2023 - PDF - English - AENOR
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€167.00

UNE-EN ISO 80369-3:2017/A1:2023

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
7/19/2023 - PDF - Spanish - AENOR
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€52.00

UNE-EN ISO 80369-3:2017/A1:2023

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
7/19/2023 - PDF - English - AENOR
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€62.40

UNE-EN ISO 8872:2023

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)
7/19/2023 - PDF - Spanish - AENOR
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€68.00

UNE-EN ISO 8872:2023

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)
7/19/2023 - PDF - English - AENOR
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€81.60

UNE-EN ISO 10943:2023

Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
7/12/2023 - PDF - Spanish - AENOR
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€57.00

UNE-EN ISO 10943:2023

Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
7/12/2023 - PDF - English - AENOR
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€68.40

UNE-EN ISO 8536-15:2022/A1:2023

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
6/21/2023 - PDF - Spanish - AENOR
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€34.00

UNE-EN ISO 8536-15:2022/A1:2023

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)
6/21/2023 - PDF - English - AENOR
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€40.80

UNE-EN IEC 61676:2023

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (Endorsed by Asociación Española de Normalización in June of 2023.)
6/3/2023 - PDF - English - AENOR
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€76.00

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)
5/17/2023 - PDF - Spanish - AENOR
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€128.00

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)
5/17/2023 - PDF - English - AENOR
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€153.60

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)
5/17/2023 - PDF - Spanish - AENOR
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€126.00

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)
5/17/2023 - PDF - English - AENOR
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€151.20

UNE-EN ISO 14708-3:2023

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
5/17/2023 - PDF - Spanish - AENOR
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€115.00

UNE-EN ISO 14708-3:2023

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
5/17/2023 - PDF - English - AENOR
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€138.00

UNE-EN ISO 14708-5:2023

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
5/3/2023 - PDF - Spanish - AENOR
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€127.00

UNE-EN ISO 14708-5:2023

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
5/3/2023 - PDF - English - AENOR
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€152.40

UNE-EN ISO 8362-2:2015/A1:2023

Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
4/26/2023 - PDF - Spanish - AENOR
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€39.00

UNE-EN ISO 8362-2:2015/A1:2023

Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
4/26/2023 - PDF - English - AENOR
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€46.80

UNE-EN ISO 8536-3:2009/A1:2023

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
4/26/2023 - PDF - Spanish - AENOR
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€34.00

UNE-EN ISO 8536-3:2009/A1:2023

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)
4/26/2023 - PDF - English - AENOR
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€40.80

UNE-EN ISO 14708-4:2023

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
4/26/2023 - PDF - Spanish - AENOR
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€118.00

UNE-EN ISO 14708-4:2023

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
4/26/2023 - PDF - English - AENOR
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€141.60

UNE-EN IEC 80601-2-59:2019/A1:2023

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)
4/21/2023 - PDF - English - AENOR
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€42.00

UNE-EN ISO 8536-2:2023

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023) (Endorsed by Asociación Española de Normalización in April of 2023.)
4/21/2023 - PDF - English - AENOR
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€62.00

UNE-EN ISO 4135:2023

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
4/19/2023 - PDF - Spanish - AENOR
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€116.00

UNE-EN ISO 4135:2023

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
4/19/2023 - PDF - English - AENOR
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€139.20

UNE-EN ISO 23368:2023

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
4/12/2023 - PDF - Spanish - AENOR
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€60.00

UNE-EN ISO 23368:2023

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
4/12/2023 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 14708-2:2023

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
4/12/2023 - PDF - Spanish - AENOR
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€128.00

UNE-EN ISO 14708-2:2023

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
4/12/2023 - PDF - English - AENOR
Learn More

€153.60

UNE-EN ISO 16628:2023

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
2/22/2023 - PDF - Spanish - AENOR
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€68.00

UNE-EN ISO 16628:2023

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
2/22/2023 - PDF - English - AENOR
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€81.60

UNE-EN ISO 80601-2-13:2023

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
2/22/2023 - PDF - Spanish - AENOR
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€150.00

UNE-EN ISO 80601-2-13:2023

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
2/22/2023 - PDF - English - AENOR
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€180.00

UNE-EN ISO 8980-3:2023

Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO 8980-3:2022)
2/22/2023 - PDF - Spanish - AENOR
Learn More

€86.00

UNE-EN ISO 8980-3:2023

Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO 8980-3:2022)
2/22/2023 - PDF - English - AENOR
Learn More

€103.20

UNE-EN ISO 23371:2023

Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)
2/1/2023 - PDF - Spanish - AENOR
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€63.00

UNE-EN ISO 23371:2023

Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)
2/1/2023 - PDF - English - AENOR
Learn More

€75.60

UNE-EN ISO 26825:2023

Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
2/1/2023 - PDF - Spanish - AENOR
Learn More

€60.00

UNE-EN ISO 26825:2023

Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
2/1/2023 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 10079-2:2022

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
12/21/2022 - PDF - Spanish - AENOR
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€46.00

UNE-EN ISO 10079-2:2022

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
12/21/2022 - PDF - English - AENOR
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€55.20

UNE-EN ISO 10079-3:2022

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
12/21/2022 - PDF - Spanish - AENOR
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€49.00

UNE-EN ISO 10079-3:2022

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
12/21/2022 - PDF - English - AENOR
Learn More

€58.80

UNE-EN ISO 23372:2022

Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
12/21/2022 - PDF - Spanish - AENOR
Learn More

€60.00

UNE-EN ISO 23372:2022

Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
12/21/2022 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 10079-1:2022

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
11/23/2022 - PDF - Spanish - AENOR
Learn More

€49.00

UNE-EN ISO 10079-1:2022

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
11/23/2022 - PDF - English - AENOR
Learn More

€58.80

UNE-EN ISO 8536-15:2022

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)
11/2/2022 - PDF - Spanish - AENOR
Learn More

€60.00

UNE-EN ISO 8536-15:2022

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)
11/2/2022 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 5832-6:2022

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)
11/2/2022 - PDF - Spanish - AENOR
Learn More

€49.00

UNE-EN ISO 5832-6:2022

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)
11/2/2022 - PDF - English - AENOR
Learn More

€58.80

UNE-EN ISO 18778:2022

Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)
10/12/2022 - PDF - English - AENOR
Learn More

€98.00

UNE-EN ISO 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€110.00

UNE-EN ISO 11608-2:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€74.00

UNE-EN ISO 11608-3:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
10/12/2022 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€101.00

UNE-EN IEC 61223-3-5:2019/AC:2022-07

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€0.00

UNE-EN IEC 60336:2021/AC:2022-07

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in August of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€0.00

UNE-EN IEC 62985:2019/AC:2022-07

Methods for calculating size specific dose estimates (SSDE) for computed tomography (Endorsed by Asociación Española de Normalización in August of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€0.00

UNE-EN 60731:2012/A1:2022

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (Endorsed by Asociación Española de Normalización in September of 2022.)
10/12/2022 - PDF - English - AENOR
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€24.00

UNE-EN IEC 60806:2023

Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis (Endorsed by Asociación Española de Normalización in February of 2023.)
10/12/2022 - PDF - English - AENOR
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€60.00

UNE-EN IEC 60601-2-43:2023

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Endorsed by Asociación Española de Normalización in March of 2023.)
10/12/2022 - PDF - English - AENOR
Learn More

€104.00

UNE-EN ISO 12312-1:2022

Eye and face protection - Sunglasses and related eyewear - Part 1: Sunglasses for general use (ISO 12312-1:2022) (Endorsed by Asociación Española de Normalización in September of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€75.00

UNE-EN 60601-1:2006/A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)
10/12/2022 - PDF - English - AENOR
Learn More

€98.00

UNE-EN ISO 10942:2022

Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
10/5/2022 - PDF - Spanish - AENOR
Learn More

€58.00

UNE-EN ISO 10942:2022

Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
10/5/2022 - PDF - English - AENOR
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€69.60

UNE-EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
9/21/2022 - PDF - Spanish - AENOR
Learn More

€74.00

UNE-EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
9/21/2022 - PDF - English - AENOR
Learn More

€88.80

UNE-EN ISO 5832-3:2022

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
9/21/2022 - PDF - Spanish - AENOR
Learn More

€60.00

UNE-EN ISO 5832-3:2022

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
9/21/2022 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 15798:2022

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
9/21/2022 - PDF - Spanish - AENOR
Learn More

€74.00

UNE-EN ISO 15798:2022

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
9/21/2022 - PDF - English - AENOR
Learn More

€88.80

UNE-EN ISO 14971:2020/A11:2022

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
6/22/2022 - PDF - Spanish - AENOR
Learn More

€52.00

UNE-EN ISO 14971:2020/A11:2022

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
6/22/2022 - PDF - English - AENOR
Learn More

€62.40

UNE-EN ISO 10079-4:2022

Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
6/22/2022 - PDF - Spanish - AENOR
Learn More

€88.00

UNE-EN ISO 10079-4:2022

Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
6/22/2022 - PDF - English - AENOR
Learn More

€105.60

UNE-EN IEC 61675-1:2022

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (Endorsed by Asociación Española de Normalización in June of 2022.)
6/1/2022 - PDF - English - AENOR
Learn More

€84.00

UNE-EN IEC 62127-1:2022

Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields (Endorsed by Asociación Española de Normalización in June of 2022.)
6/1/2022 - PDF - English - AENOR
Learn More

€140.00

UNE-EN IEC 61689:2022

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz (Endorsed by Asociación Española de Normalización in June of 2022.)
6/1/2022 - PDF - English - AENOR
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€105.00

UNE-EN ISO 10651-5:2022

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
5/25/2022 - PDF - Spanish - AENOR
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€100.00

UNE-EN ISO 10651-5:2022

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
5/25/2022 - PDF - English - AENOR
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€120.00

UNE-EN ISO 80369-7:2022

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
5/25/2022 - PDF - Spanish - AENOR
Learn More

€102.00

UNE-EN ISO 80369-7:2022

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
5/25/2022 - PDF - English - AENOR
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€122.40

UNE-EN ISO 407:2022

Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021)
4/13/2022 - PDF - Spanish - AENOR
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€70.00

UNE-EN ISO 407:2022

Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021)
4/13/2022 - PDF - English - AENOR
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€84.00

UNE-EN ISO 15223-1:2022

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
3/16/2022 - PDF - Spanish - AENOR
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€111.00

UNE-EN ISO 15223-1:2022

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
3/16/2022 - PDF - English - AENOR
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€133.20

UNE-EN ISO 22413:2022

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
3/16/2022 - PDF - Spanish - AENOR
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€68.00

UNE-EN ISO 22413:2022

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
3/16/2022 - PDF - English - AENOR
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€81.60

UNE-EN ISO 19980:2022

Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
3/9/2022 - PDF - Spanish - AENOR
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€74.00

UNE-EN ISO 19980:2022

Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
3/9/2022 - PDF - English - AENOR
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€88.80

UNE-EN ISO 19223:2022

Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)
3/2/2022 - PDF - Spanish - AENOR
Learn More

€165.00

UNE-EN ISO 19223:2022

Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)
3/2/2022 - PDF - English - AENOR
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€198.00

UNE-EN IEC 81001-5-1:2022

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)
3/1/2022 - PDF - English - AENOR
Learn More

€95.00

UNE-EN ISO 9713:2022

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022) (Endorsed by Asociación Española de Normalización in March of 2022.)
3/1/2022 - PDF - English - AENOR
Learn More

€58.00

UNE-EN IEC 61223-3-7:2022

Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography (Endorsed by Asociación Española de Normalización in March of 2022.)
3/1/2022 - PDF - English - AENOR
Learn More

€84.00

UNE-EN IEC 60601-2-41:2021

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Endorsed by Asociación Española de Normalización in February of 2022.)
2/1/2022 - PDF - English - AENOR
Learn More

€101.00

UNE-EN IEC 62563-2:2021

Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays (Endorsed by Asociación Española de Normalización in February of 2022.)
2/1/2022 - PDF - English - AENOR
Learn More

€78.00

UNE-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
12/7/2021 - PDF - Spanish - AENOR
Learn More

€127.00

UNE-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
12/7/2021 - PDF - English - AENOR
Learn More

€152.40

UNE-EN IEC 80001-1:2021

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
Learn More

€78.00

UNE-EN IEC 80601-2-26:2020/AC:2021-10

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
Learn More

€0.00

UNE-EN 50527-2-3:2021

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
Learn More

€138.00

UNE-EN ISO 80601-2-85:2021

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
11/24/2021 - PDF - Spanish - AENOR
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€150.00

UNE-EN ISO 80601-2-85:2021

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
11/24/2021 - PDF - English - AENOR
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€180.00

UNE-EN ISO 80601-2-67:2021

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
11/10/2021 - PDF - Spanish - AENOR
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€112.00

UNE-EN ISO 80601-2-67:2021

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
11/10/2021 - PDF - English - AENOR
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€134.40

UNE-EN ISO 80601-2-69:2021

Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
11/10/2021 - PDF - Spanish - AENOR
Learn More

€124.00

UNE-EN ISO 80601-2-69:2021

Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
11/10/2021 - PDF - English - AENOR
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€148.80

UNE-EN ISO 80601-2-90:2021

Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)
11/1/2021 - PDF - English - AENOR
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€136.00

UNE-EN IEC 80601-2-77:2021

Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in November of 2021.)
11/1/2021 - PDF - English - AENOR
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€98.00

UNE-EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020) (Endorsed by Asociación Española de Normalización in November of 2021.)
11/1/2021 - PDF - English - AENOR
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€69.00

UNE-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
10/13/2021 - PDF - Spanish - AENOR
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€71.00

UNE-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
10/13/2021 - PDF - English - AENOR
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€85.20

UNE-EN ISO 8536-12:2021

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)
10/6/2021 - PDF - Spanish - AENOR
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€68.00

UNE-EN ISO 8536-12:2021

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)
10/6/2021 - PDF - English - AENOR
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€81.60

UNE-EN ISO 80601-2-74:2021

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021) (Endorsed by Asociación Española de Normalización in October of 2021.)
10/1/2021 - PDF - English - AENOR
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€140.00

UNE-EN 62563-1:2010/A2:2021

Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (Endorsed by Asociación Española de Normalización in October of 2021.)
10/1/2021 - PDF - English - AENOR
Learn More

€63.00

UNE-EN ISO 14155:2021

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/22/2021 - PDF - Spanish - AENOR
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€138.00

UNE-EN ISO 14155:2021

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/22/2021 - PDF - English - AENOR
Learn More

€165.60

UNE-EN ISO 15004-1:2021

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
9/22/2021 - PDF - Spanish - AENOR
Learn More

€60.00

UNE-EN ISO 15004-1:2021

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
9/22/2021 - PDF - English - AENOR
Learn More

€72.00

UNE-EN 60601-1-8:2007/A2:2021

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€100.00

UNE-EN 60601-1-11:2015/A1:2021

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€63.00

UNE-EN IEC 60601-2-35:2021

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€112.00

UNE-EN IEC 60601-2-19:2021

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
Learn More

€81.00

UNE-EN IEC 60601-2-21:2021

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
Learn More

€80.00

UNE-EN 80369-5:2017/AC:2021-06

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
9/1/2021 - PDF - Spanish - AENOR
Learn More

€0.00

UNE-EN 80369-5:2017/AC:2021-06

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
9/1/2021 - PDF - English - AENOR
Learn More

€0.00

UNE-EN IEC 60601-2-1:2021

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€147.00

UNE-EN IEC 60601-2-50:2021

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
Learn More

€75.00

UNE-EN ISO 15253:2021

Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021) (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
Learn More

€75.00

UNE-EN 60601-1-6:2010/A2:2021

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€60.00

UNE-EN 60601-1-10:2008/A2:2021

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Endorsed by Asociación Española de Normalización in September of 2021.)
9/1/2021 - PDF - English - AENOR
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€63.00

UNE-EN 60601-2-63:2015/A2:2021

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2021.)
8/1/2021 - PDF - English - AENOR
Learn More

€62.00

UNE-EN 60601-2-65:2013/A2:2021

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in July of 2021.)
7/1/2021 - PDF - English - AENOR
Learn More

€46.00

UNE-EN IEC 61010-2-130:2021

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-130: Particular requirements for equipment intended to be used in educational establishments by children
7/1/2021 - PDF - English - AENOR
Learn More

€72.00

UNE-EN ISO 80601-2-87:2021

Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021) (Endorsed by Asociación Española de Normalización in June of 2021.)
6/1/2021 - PDF - English - AENOR
Learn More

€167.00

UNE-EN IEC 61010-2-091:2021

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems (Endorsed by Asociación Española de Normalización in June of 2021.)
6/1/2021 - PDF - English - AENOR
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€74.00

UNE-EN IEC 61010-2-091:2021/A11:2021

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems (Endorsed by Asociación Española de Normalización in June of 2021.)
6/1/2021 - PDF - English - AENOR
Learn More

€28.00

UNE-EN 60601-1-2:2015/A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)
5/1/2021 - PDF - English - AENOR
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€76.00

UNE-EN IEC 60601-2-83:2020/A11:2021

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2021.)
5/1/2021 - PDF - English - AENOR
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€46.00

UNE-EN ISO 7376:2021

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
4/28/2021 - PDF - Spanish - AENOR
Learn More

€70.00

UNE-EN ISO 7376:2021

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
4/28/2021 - PDF - English - AENOR
Learn More

€84.00

UNE-EN ISO 8836:2021

Suction catheters for use in the respiratory tract (ISO 8836:2019)
4/28/2021 - PDF - Spanish - AENOR
Learn More

€74.00

UNE-EN ISO 8836:2021

Suction catheters for use in the respiratory tract (ISO 8836:2019)
4/28/2021 - PDF - English - AENOR
Learn More

€88.80

UNE-EN ISO 81060-2:2020/A1:2021

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
4/28/2021 - PDF - Spanish - AENOR
Learn More

€46.00

UNE-EN ISO 81060-2:2020/A1:2021

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
4/28/2021 - PDF - English - AENOR
Learn More

€55.20

UNE-EN ISO 25539-2:2021

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
4/28/2021 - PDF - Spanish - AENOR
Learn More

€157.00

UNE-EN ISO 25539-2:2021

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
4/28/2021 - PDF - English - AENOR
Learn More

€188.40

UNE-EN ISO 11978:2018/A1:2021

Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
4/28/2021 - PDF - Spanish - AENOR
Learn More

€52.00

UNE-EN ISO 11978:2018/A1:2021

Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
4/28/2021 - PDF - English - AENOR
Learn More

€62.40

UNE-EN ISO 11979-5:2021

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
4/28/2021 - PDF - Spanish - AENOR
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€83.00

UNE-EN ISO 11979-5:2021

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
4/28/2021 - PDF - English - AENOR
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€99.60

UNE-EN ISO 17510:2021

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
4/7/2021 - PDF - Spanish - AENOR
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€82.00

UNE-EN ISO 17510:2021

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
4/7/2021 - PDF - English - AENOR
Learn More

€98.40

UNE-EN IEC 60522-1:2021

Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration (Endorsed by Asociación Española de Normalización in April of 2021.)
4/1/2021 - PDF - English - AENOR
Learn More

€69.00

UNE-EN 60601-1-3:2008/A2:2021

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Endorsed by Asociación Española de Normalización in April of 2021.)
4/1/2021 - PDF - English - AENOR
Learn More

€42.00

UNE-EN ISO 5840-1:2021

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
3/1/2021 - PDF - English - AENOR
Learn More

€124.00

UNE-EN ISO 5840-2:2021

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
3/1/2021 - PDF - English - AENOR
Learn More

€98.00

UNE-EN ISO 5840-3:2021

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
3/1/2021 - PDF - English - AENOR
Learn More

€104.00

UNE-EN IEC 60336:2021

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in March of 2021.)
3/1/2021 - PDF - English - AENOR
Learn More

€88.00

UNE-EN ISO 8624:2021

Ophthalmic optics - Spectacle frames - Measuring system and vocabulary (ISO 8624:2020)
2/10/2021 - PDF - Spanish - AENOR
Learn More

€68.00

UNE-EN ISO 8624:2021

Ophthalmic optics - Spectacle frames - Measuring system and vocabulary (ISO 8624:2020)
2/10/2021 - PDF - English - AENOR
Learn More

€81.60

UNE-EN ISO 8624:2021

Ophthalmic optics - Spectacle frames - Measuring system and vocabulary (ISO 8624:2020)
2/10/2021 - PDF - Galician - AENOR
Learn More

€68.00

UNE-EN IEC 61010-2-202:2021

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-202: Particular requirements for electrically operated valve actuators (Endorsed by Asociación Española de Normalización in February of 2021.)
2/1/2021 - PDF - English - AENOR
Learn More

€65.00