Laboratorio de equipos medicos
El laboratorio NO RISK STE realiza pruebas
de seguridad y rendimiento en equipos medicos de acuerdo
con las siguientes normas técnicas:
- IEC 60601-1 - Medical
electrical equipment - Part 1: General requirements for basic
safety and essential performance.
- IEC 60601-1-6 - Medical
electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral Standard:
Usability.
- IEC 60601-1-8 - 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.
- IEC 60601-1-9 - Medical
electrical equipment - Part 1-9: General requirements for
basic safety and essential performance - Collateral Standard:
Requirements for environmentally conscious design.
- IEC 60601-1-10 - 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.
- IEC 60601-1-11 - Medical
electrical equipment - Part 1-11 - Requirements for medical
electrical equipment and medical electrical systems used in
the home healthcare environment.
- IEC 60601-1-12 - Medical
electrical equipment - Part 1-12 - Requirements for medical
electrical equipment and medical electrical systems intended
for use in the emergency medical services environment.
- IEC 60601-2-3 –
Particular requirements for basic safety and essential
performance of short-wave therapy equipment.
- IEC 60601-2-5 –
Particular requirements for basic safety and essential
performance of ultrassonic physiotherapy equipment.
- IEC 60601-2-10 –
Particular requirements for basic safety and essential
performance of nerve and muscle stimulators.
- ISO 80601-2-12 –
Particular requirements for basic safety and essential
performance of critical care ventilators.
- ISO 80601-2-13 –
Particular requirements for basic safety and essential
performance of an anaesthetic workstation.
- IEC 60601-2-18–
Particular requirements for basic safety and essential
performance of endoscopic equipment.
- IEC 60601-2-19 –
Particular requirements for basic safety and essential
performance of infant incubators.
- IEC 60601-2-20 –
Particular requirements for basic safety and essential
performance of infant transport incubators.
- IEC 60601-2-21 –
Particular requirements for basic safety and essential
performance of infant radiant warmers.
- IEC 60601-2-22 –
Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic
laser equipment.
- IEC 60601-2-23 –
Particular requirements for basic safety and essential
performance of transcutaneous partial pressure monitoring
equipment.
- IEC 60601-2-24 –
Particular requirements for basic safety and essential
performance of infusion pumps and controllers.
- IEC 60601-2-25 –
Particular requirements for basic safety and essential
performance of electrocardiographs.
- IEC 60601-2-26 –
Particular requirements for basic safety and essential
performance of electroencephalographs.
- IEC 60601-2-27 –
Particular requirements for basic safety and essential
performance of electrocardiographic monitoring equipment.
- IEC 80601-2-30 –
Particular requirements for basic safety and essential
performance of automated non-invasive sphygmomanometers.
- IEC 60601-2-31 –
Particular requirements for basic safety and essential
performance of external cardiac pacemaker.
- IEC 60601-2-34 –
Particular requirements for basic safety and essential
performance of invasive blood pressure monitoring equipment.
- IEC 80601-2-35 -
Particular requirements for basic safety and essential
performance of heating devices using blankets, pads or
mattresses and intended for heating in medical use.
- IEC 60601-2-37 –
Particular requirements for basic safety and essential
performance of ultrasonic medical diagnostic and monitoring
equipment.
- IEC 60601-2-39 –
Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment.
- IEC 60601-2-40 –
Particular requirements for basic safety and essential
performance of electromyographs and evoke response equipment.
- IEC 60601-2-41 –
Particular requirements for basic safety and essential
performance of surgical luminaries and luminaries for
diagnosis.
- IEC 60601-2-46 –
Particular requirements for basic safety and essential
performance of operating tables.
- IEC 60601-2-47 –
Particular requirements for basic safety and essential
performance of ambulatory electrocardiographic systems.
- IEC 60601-2-49 –
Particular requirements for basic safety and essential
performance of multi function monitoring equipment.
- IEC 60601-2-50 –
Particular requirements for basic safety and essential
performance of infant phototherapy equipment.
- ISO 80601-2-55 –
Particular requirements for basic safety and essential
performance of respiratory gas monitors.
- ISO 80601-2-56 –
Particular requirements for basic safety and essential
performance of clinical thermometers for body temperature
measurement.
- IEC 60601-2-57 –
Particular requirements for basic safety and essential
performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic
use.
- IEC 80601-2-58 –
Particular requirements for basic safety and essential
performance of lens removal devices and vitrectomy devices for
ophthalmic surgery.
- IEC 80601-2-60: –
Particular requirements for basic safety and essential
performance of dental equipment.
- IEC 80601-2-61 –
Particular requirements for basic safety and essential
performance of pulse oximeter equipment.
- IEC 60601-2-62 –
Particular requirements for basic safety and essential
performance of high intensity therapeutic ultrasound (HITU)
equipment.
- IEC 60601-2-66 –
Particular requirements for basic safety and essential
performance of hearing aids.
- ISO 60601-2-74 –
Particular requirements for basic safety and essential
performance of respiratory humidifying equipment.
- ISO 14457 – Dentistry –
Handpieces and Motors.
- ISO 6875 – Dentistry -
Patient chair.
- ISO 9680 – Dentistry -
Operating lights.
- ISO 11195 – Gas mixers
for medical use – Stand alone gas mixers.
- ISO 10651-3 – Lung
ventilators – Part 3: Particular requirements for emergency
and transport ventilators.
- ISO 10651-4 – Lung
ventilators – Part 4: Particular requirements for operator
powered resuscitators.
- ISO 8185 – Respiratory
tract humidifiers for medical use – Particular requirements
for respiratory humidification systems.
- ISO 7494-1 – Dentistry –
Dental units – Part 1: General requirements and test methods.
- ISO 7494-2 – Dentistry –
Dental units – Part 2: Air, water, suction and wastewater
systems.
- ISO 5356-1 – Anaesthetic
and respiratory equipment – Conical connectors - Part 1 –
Cones and sockets.
- ISO 5362 – Anaesthetic
reservoir bags.
- ISO 5367 – Anaesthetic
and respiratory equipment – Breathing sets and connectors
- ISO 10535 – Hoists for
the transfer of disabled persons
Solicitar
presupuesto
