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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: 314

UNE-EN 60601-1-9:2008/A2:2020 (Ratificada)

Status: VIGENTE / 2020-10-01

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (Endorsed by Asociación Española de Normalización in October of 2020.)

UNE-EN 62366-1:2015/A1:2020 (Ratificada)

Status: VIGENTE / 2020-09-01

Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)

UNE-EN IEC 61223-3-6:2020 (Ratificada)

Status: VIGENTE / 2020-05-01

Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN IEC 60580:2020 (Ratificada)

Status: VIGENTE / 2020-05-01

Medical electrical equipment - Dose area product meters (Endorsed by Asociación Española de Normalización in May of 2020.)

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 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 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 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 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 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 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.)

UNE-EN IEC 60601-2-39:2019 (Ratificada)

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 IEC 60601-2-76:2019 (Ratificada)

Status: VIGENTE / 2019-07-01

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 July of 2019.)

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