11.040 : Medical equipment
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DIN EN IEC 62985 Berichtigung 1:2023-10
Methods for calculating size specific dose estimate (SSDE) on computed tomography (IEC 62985:2019/COR1:2022), German version EN IEC 62985:2019/AC:2022
10/1/2023 - PDF - German -
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DIN EN ISO 80601-2-74 Berichtigung 1:2023-09
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021), German version EN ISO 80601-2-74:2021, Corrigendum 1
9/1/2023 - PDF - German -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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DIN EN 61303 Berichtigung 1:2017-03
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance (IEC 61303:1994), German version EN 61303:1995, Corrigendum to DIN EN 61303:1996-03, (IEC 61303:1994/COR1:2016), German version EN 61303:1995/AC:2016
3/1/2017 - PDF - German -
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UNE-EN 61303:1997/AC:2016-07
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
9/28/2016 - PDF - English -
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UNE-EN 61303:1997/AC:2016-07
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
9/28/2016 - PDF - Spanish -
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UNE-EN 60601-2-33:2010/AC:2016-03
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Endorsed by AENOR in April of 2016.)
4/1/2016 - PDF - English -
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UNE-EN 62366-1:2015/AC:2015
Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in February of 2016.)
2/1/2016 - PDF - English -
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DIN 6847-5 Berichtigung 1:2015-04
Medical electron accelerators - Part 5: Constancy tests of functional performance characteristics, Corrigendum to DIN 6847-5:2013-10
4/1/2015 - PDF - German -
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UNE-EN 60601-2-43:2010/AC:2014
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (Endorsed by AENOR in September of 2014.)
9/1/2014 - PDF - English -
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UNE-EN 60601-1-8:2008/A1:2013/AC:2014
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
6/25/2014 - PDF - Spanish -
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UNE-EN 60601-1-3:2008/A1:2013/AC:2014
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
6/25/2014 - PDF - Spanish -
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UNE-EN 60601-1-8:2008/A1:2013/AC:2014
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
6/25/2014 - PDF - English -
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UNE-EN 60601-1-3:2008/A1:2013/AC:2014
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
6/25/2014 - PDF - English -
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UNE-EN 60601-1:2008 CORR:2010
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
6/16/2010 - PDF - English -
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UNE-EN 60601-1-3:2008 CORR:2010
Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
6/16/2010 - PDF - English -
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UNE-EN 60601-1-8:2008 CORR:2010
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
6/16/2010 - PDF - Spanish -
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UNE-EN 60601-1:2008 CORR:2010
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
6/16/2010 - PDF - Spanish -
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UNE-EN 60601-1-3:2008 CORR:2010
Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
6/16/2010 - PDF - Spanish -
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UNE-EN 60601-1-8:2008 CORR:2010
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
6/16/2010 - PDF - English -
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UNE-EN 15333-1:2008/AC:2010
Respiratory equipment - Open-circuit umbilical supplied compressed gas diving apparatus - Part 1: Demand apparatus
4/28/2010 - PDF - English -
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UNE-EN 15333-1:2008/AC:2010
Respiratory equipment - Open-circuit umbilical supplied compressed gas diving apparatus - Part 1: Demand apparatus
4/28/2010 - PDF - Spanish -
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ISO 26782:2009/Cor 1:2009
Anaesthetic and respiratory equipment
Spirometers intended for the measurement of time forced expired volumes in humans
11/5/2009 - Paper - French -
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ISO 26782:2009/Cor 1:2009
Anaesthetic and respiratory equipment
Spirometers intended for the measurement of time forced expired volumes in humans
11/5/2009 - Paper - English -
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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)
9/2/2009 - PDF - English -
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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)
9/2/2009 - PDF - Spanish -
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UNE-EN 60601-1:2008 ERRATUM:2008
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
11/26/2008 - PDF - Spanish -
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UNE-EN 60601-1:2008 ERRATUM:2008
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
11/26/2008 - PDF - English -
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ISO 7197:2006/Cor 1:2007
Neurosurgical implants
Sterile, single-use hydrocephalus shunts and components
7/2/2007 - Paper - French -
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ISO 7197:2006/Cor 1:2007
Neurosurgical implants
Sterile, single-use hydrocephalus shunts and components
7/2/2007 - Paper - English -
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ISO 16034:2002/Cor 1:2006
Ophthalmic optics
Specifications for single-vision ready-to-wear near- vision spectacles
7/24/2006 - Paper - French -
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UNE-EN 61676:2003 ERRATUM
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology.
10/24/2003 - PDF - Spanish -
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UNE-EN 13726-1:2003 ERRATUM (R2012)
Test methods for primary wound dressings. Part 1: Aspects of absorbency.
9/19/2003 - PDF - Spanish -
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UNE-EN 61847:2003 ERRATUM
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics.
2/21/2003 - PDF - Spanish -
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UNE-EN ISO 9703-3:2000 ERRATUM
Anaesthetic and respiratory care alamr signals. Part 3: Guidance on application of alarms. (ISO 9703-3:1998).
1/28/2000 - PDF - Spanish -
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UNE-EN 27740/AC:1996
INSTRUMENTS FOR SURGERY. SCALPES WITH DETACHABLE BLADES. FITTING DIMENSIONS. (ISO 7740:1985).
10/23/1996 - PDF - Spanish -
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UNE-EN 27740/AC:1996
INSTRUMENTS FOR SURGERY. SCALPES WITH DETACHABLE BLADES. FITTING DIMENSIONS. (ISO 7740:1985).
10/23/1996 - PDF - English -
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UNE-EN IEC 61676:2023/AC:2024-02
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 March of 2024.)
4/25/2024 - PDF - English -
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