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UNE-EN ISO 16061:2021 UNE
Status: Vigente/ 2021-10-13
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
UNE-EN ISO 23907-1:2019 UNE
Status: Vigente/ 2019-10-09
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)
UNE-EN ISO 19054:2007/A1:2017 UNE
Status: Vigente/ 2017-03-29
Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
UNE-EN 60601-2-25:2016 UNE
Status: Vigente/ 2016-09-28
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
UNE-EN 60601-2-66:2016 UNE
Status: Anulada/ 2023-02-20
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
UNE-EN 60601-2-41:2010/A1:2015 UNE
Status: Anulada/ 2024-10-09
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
UNE-EN ISO 16061:2015 UNE
Status: Anulada/ 2021-10-13
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
UNE-EN ISO 23908:2013 UNE
Status: Vigente/ 2013-04-03
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
UNE-EN ISO 23907:2013 UNE
Status: Anulada/ 2020-03-01
Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012)
UNE-EN ISO 11990-1:2012 UNE
Status: Anulada/ 2014-12-01
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
UNE-EN 60601-2-41:2010/A11:2012 UNE
UNE-EN ISO 23908:2011 UNE
Status: Anulada/ 2013-04-03
UNE-EN 60601-2-41:2010 UNE
UNE-EN ISO 16061:2010 UNE
Status: Anulada/ 2015-09-16
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
UNE-EN ISO 16061:2009 UNE
Status: Anulada/ 2010-01-13
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
UNE-EN ISO 18777:2009 UNE
Status: Vigente/ 2009-06-10
Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
UNE-EN ISO 19054:2007 UNE
Status: Vigente/ 2007-05-16
Rail systems for supporting medical equipment (ISO 19054:2005)
UNE-EN ISO 18777:2005 UNE
Status: Anulada/ 2010-03-22
UNE-EN 60601-2-26:2004 UNE
Status: Anulada/ 2018-04-15
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
UNE-EN ISO 11990:2004 UNE
Status: Anulada/ 2012-07-25
Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)
UNE-EN 12218/A1:2002 UNE
Status: Anulada/ 2008-07-01
Rail systems for supporting medical equipment.
UNE-EN ISO 11990:2001 UNE
Status: Anulada/ 2004-06-11
Optics and optical instruments -- Lasers and laser-related equipment -- Determination of laser resistance of tracheal tube shafts. (ISO 11990:1999)
UNE-EN 60601-2-41:2001 UNE
Status: Anulada/ 2012-11-01
Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis.
UNE-EN 12218:1999 UNE
RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT
UNE 20613-2-10:1992 UNE
Status: Anulada/ 2001-09-21
MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF NERVE AND MUSCLE STIMULATORS
UNE 20613-2-4:1989 UNE
Status: Anulada/ 2005-10-01
MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS AND CARDIAC DEFIBRILLATOR-MONITORS
UNE 20613-2-1:1985 UNE
Status: Anulada/ 2001-11-08
SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR MEDICAL ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV. SECTION ONE: GENERAL. SECTION TWO: RADIATION SAFETY FOR EQUIPMENT
UNE-EN IEC 80601-2-26:2020/A1:2024 UNE
Status: Vigente/ 2024-05-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2024.)
UNE-EN ISO 11990:1999 UNE
Status: Anulada/ 2001-05-24
Optics and optical instruments -- Lasers and laser-related equipment -- Determination of laser resistance of tracheal tube shafts (ISO 11990:1999). (Endorsed by AENOR in December of 2000.)
UNE-EN ISO 11990-2:2010 UNE
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010) (Endorsed by AENOR in April of 2011.)
UNE-EN 60601-2-26:2015 UNE
Status: Anulada/ 2023-04-04
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by AENOR in July of 2015.)
UNE-EN ISO 11990:2018 UNE
Status: Vigente/ 2018-12-01
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018) (Endorsed by Asociación Española de Normalización in December of 2018.)
UNE-EN ISO 11990-1:2014 UNE
Status: Anulada/ 2018-12-01
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) (Endorsed by AENOR in December of 2014.)
UNE-EN ISO 11990-2:2014 UNE
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010) (Endorsed by AENOR in December of 2014.)
UNE-EN IEC 60601-2-66:2020 UNE
Status: Vigente/ 2020-05-01
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 80601-2-26:2020 UNE
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 60601-2-39:2019 UNE
Status: Vigente/ 2019-07-01
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (Endorsed by Asociación Española de Normalización in July of 2019.)
UNE-EN 60601-2-40:2019 UNE
Status: Vigente/ 2019-02-01
Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in February of 2019.)
UNE-EN IEC 80601-2-26:2020/AC:2021-10 UNE
Status: Vigente/ 2021-12-01
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.)
UNE-EN IEC 60601-2-41:2021 UNE
Status: Vigente/ 2022-02-01
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.)
UNE-EN IEC 60601-2-40:2025 UNE
Status: Vigente/ 2025-03-01
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in March of 2025.)
UNE-EN IEC 60601-2-39:2025 UNE
Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment (Endorsed by Asociación Española de Normalización in March of 2025.)
PNE-prEN ISO 21762 PROY
Status: Procedure
Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)
PNE-prEN ISO 12487 PROY
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)
PNE-prEN ISO 18777-1 PROY
Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO/FDIS 18777-1:2025)
PNE-prEN IEC 60601-2-91:2024 PROY
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment
PNE-EN ISO 23908 PROY
Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO 23908:2024)
ISO 18665:2022 ISO
Status: Published/ 2022-02-15
Traditional Chinese medicine — Herbal decoction apparatus
ISO 18666:2021 ISO
Status: Published/ 2021-11-16
Traditional Chinese medicine — General requirements of moxibustion devices
ISO 16061:2021 ISO
Status: Published/ 2021-03-15
Instruments for use in association with non-active surgical implants — General requirements
