CKI team (CHEN KUANG Industries Company LTD) with Global & International certification and approved of registration as below.
1. International Certification：
ISO13485 Approved、CE Approved
2. Taiwan R.O.C. (Republic of China) Medical Series Certification
Medical Device Legally Sell Approved、Medical Device Legally Sell Approved、GMP(Good Manufacturing Practice) Manufacture Factory Approved
3. Safety agency approval and certification
IEC 60601-1-1 Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00).
The general standard IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards.
IEC 60601-1-2 Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04).
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-38 Electrically Operated Hospital Beds (10/96), Am.1 (12/99), (Next Ed. will be IEC 60601-2-52).
IEC 60601-2-38 Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds
4. Medical device product license and approved
Electrical Hospital & Nursing Medical-Care Beds Series、Manual Hospital & Nursing Medical-Care Beds Series、Hospital Emergency Stretcher & Transport Beds Trolley Series、Adjustable Hydraulic Medical Bath Beds & Mobile Surgical Shower Trolley Series
Medical & Hospital Mattresses and Pads、Mobile Telescoping IV Pole & Stainless Steel Intravenous Stand 、Alternative Pressure Air Mattress Bed & Classic Downy Inflatable Airbed Mattress、Nonpowered Orthopedic Traction Apparatus Components and Accessories
5. SGS (Societe Generale de Surveillance S.A.) & other testing report.