16 statutory and regulatory requirements, Statutory and regulatory requirements, Cardioperfect workstation – Welch Allyn CardioPerfect Workstation SpiroPerfect Module - User Manual User Manual
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16 Statutory and Regulatory Requirements
MDD - Medical Device Directive (MDD) 93/42/EEC
IEC/EN 60601-1-1, Medical Electrical Equipment, General Requirements for safety, Safety
requirements for medical electrical systems.
IEC/EN 60601-1 Medical Electrical Equipment
– General Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment - Safety Requirements - EMC
IEC/EN 60601-1-4 Collateral Standard for Programmable Medical Systems
CAN/CSA C22.2 No. 601.1-M90/UL 60601-1, Medical Electrical Equipment
– General
Requirements for Safety
Regulatory Affairs Representative
Welch Allyn, Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
4341 State Street Road
Skaneateles Falls, NY 13153 USA
Tel: 800 535-6663 (North America Only) or 315 685-4560
Fax: 315 685-3361
www.welchallyn.com