new requirements for medical emc

INTERTEK ITALIA SPA

Feb 03, 2021 · TL-451 INTERTEK ITALIA S P A Page 3 of 15 CONSOLIDATED VERSION IEC 60601-1-8 Edition 2 1 2012-11 Medical electrical equipment – Part 1-8: General requirements for basic safety

510(k) Summary K t &2 Teratech Corporation

Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems o Intertek Project: 9157933B0X-002B * IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for Medical Electrical Systems o Intertek Project: 9157933B0X-003B * lEG 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2:

SMITHS MEDICAL INTERNATIONAL LIMITED

requirements of the Notified Body AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473 EC Certification FULL QUALITY ASSURANCE SYSTEM Directive 93/42/EEC for Medical Devices, Annex II excluding (4)

Nissha Medical Technologies, Vermed,

Intertek Certification AB P O Box 1103, SE-164 22 Kista, Sweden This is to certify that the management system of: Graphic Controls d b a Nissha Medical Technologies, Vermed, Biomedical Innovations Main site: 400 Exchange St, Buffalo, New York 14204, United States has been registered by Intertek as conforming to the requirements of

Initial Certification Date: Graphic Controls dba Nissha

Medical Technologies, Vermed, Biomedical Innovations (FIN F000831) Main Site: 400 Exchange Street, Buffalo, New York, 14204, USA has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of: ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1

This is to certify that the quality management system of

EaglePicher Medical Power, LLC & EaglePicher Energy Products Corporation Divisions of EaglePicher Technologies, LLC Main Site: EaglePicher Technologies, LLC 8230 East 23rd Street Joplin, Missouri, 64804 USA Additional sites: Refer to Appendix has been assessed by Intertek as conforming to the requirements of: ISO 13485:2016