Committee

Committee:

CTN 209/SC 62 - Electrical equipment in medical practice

Secretary:
UNE - ASOCIACIÓN ESPAÑOLA DE NORMALIZACIÓN
International Relations:

IEC/TC 62  Electrical equipment in medical practice

CLC/TC 62  Electrical equipment in medical practice

Standards developed by the committee: CTN 209/SC 62: 312

UNE-EN IEC 80601-2-26:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

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 2020.)

UNE-EN IEC 60601-2-31:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN 60601-2-43:2010/A2:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

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 May of 2020.)

UNE-EN IEC 80601-2-60:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN 60601-2-65:2013/A1:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

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 May of 2020.)

UNE-EN IEC 80601-2-78:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

Medical Electrical Equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN IEC 60601-2-83:2020 (Ratificada)

Status: VIGENTE /  2020-05-01

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 2020.)

UNE-EN IEC 63077:2019 (Ratificada)

Status: VIGENTE /  2020-02-01

Good refurbishment practices for medical imaging equipment (Endorsed by Asociación Española de Normalización in February of 2020.)

UNE-EN IEC 61223-3-5:2019 (Ratificada)

Status: VIGENTE /  2019-12-01

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment

UNE-EN IEC 62985:2019 (Ratificada)

Status: VIGENTE /  2019-12-01

Methods for calculating size specific dose estimates (SSDE) on computed tomography (Endorsed by Asociación Española de Normalización in December of 2019.)

UNE-EN 60601-2-4:2011/A1:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN IEC 60601-2-28:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN IEC 80601-2-49:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN IEC 80601-2-59:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

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 November of 2019.)

UNE-EN 60601-2-63:2015/A1:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

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 November of 2019.)

UNE-EN IEC 60601-2-75:2019 (Ratificada)

Status: VIGENTE /  2019-11-01

Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN 80601-2-58:2015/A1:2019 (Ratificada)

Status: VIGENTE /  2019-10-01

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (Endorsed by Asociación Española de Normalización in October of 2019.)

UNE-EN 60601-2-45:2011 (Ratificada)

Status: VIGENTE /  2019-08-21

Medical electrical equipment -- Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (Endorsed by AENOR in July of 2011.)

UNE-EN IEC 60601-2-16:2019 (Ratificada)

Status: VIGENTE /  2019-07-01

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in July of 2019.)

UNE-EN IEC 80601-2-30:2019 (Ratificada)

Status: VIGENTE /  2019-07-01

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Endorsed by Asociación Española de Normalización in July of 2019.)

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