Certifications

Providing safety and security with every medical device we produce

ISO 13485:2016

At Lucas Lifecare, we are proud to announce that our manufacturing facility has obtained ISO 13485 certification, the globally recognized standard for medical device quality management systems.

This achievement reflects our commitment to:

Excellence in Manufacturing – Consistent processes built on precision and safety.
Global Compliance – Alignment with international regulatory requirements.
Trust & Reliability – Delivering products that healthcare professionals can depend on.

Standards, Tests & Certifcations for LifeUltra:

EN 61010-1: 2010 / AM1:2016 / COR1:2019"
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
IEC 61010-2-040:2021EN
IEC 61326-1: 2021
IEC 61326-1 Edition 3.0 2020-10
EN 13060:2014+A1:2018
AAMI ANSI ST 55 : 2016
AAMI ANSI ST55:2016/(R)2023
IEC 62304:2006
ASME BPVC Sec VIII, Div I: 2019
CFR 47, FCC Part 15B (using ANSI C63.4: 2014)
ISO 62366-1
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
ISO 17665:2024
ISO 17665 First edition 2024-03
IEC 60601-4-2
IEC 60601-1-2 ed 4.1
IEC TR 60601-4-2 Edition 1.0 2016-05
IEC 60601-1-2:2014+AMD1:2020 CONSOLIDATED VERSION edition 4.1

Standards, Tests & Certifcations for LifeRay:

FDA Cleared for LifeRay

K241305

IEC 60601-1 Safety requirements for Medical Electrical Systems
IEC 60601-1-2 Electromagnetic disturbances for Medical Electrical Systems
IEC 60601-1-3 Radiation protection in Diagnostic X -ray Equipment
IEC 60601-2-28 X-ray tube assemblies for medical diagnosis
IEC 60601-2-65 Dental intra-oral X -ray Equipment
IEC 62304 ed 1.1 Software life cycle processes for Medical Devices
IEC 62366-1 ed 1.0 Usability Engineering Application Medical Devices
21CFR sub chapter-J FDA Radiological Health Regulation