MECA IEC 60601-1, Edition 3.1 Risk Management …

← Back to document page

MECA IEC 60601 -1 Risk Management guidance Document Rev 1 (2016-06-27) Page 1 of 13 2016 Medical Equipment Compliance Associates - All Rights Reserved MECA IEC 60601 -1 Risk Management guidance Document MECA IEC 60601 -1, Edition Risk Management guidance -Review Document The purpose of this document is to identify the IEC 60601 -1 risk Management requirements, and to specify where applicable items are located in your device risk Management documentation. External References: IEC 60601 -1:2012, Edition 3 + Amendment 1 ( Edition ); ISO 14971:2007 Medical devices - Application of risk Management to medical devices Note: For ISO 14971 requirements in Clause , see separate MECA ISO 14971 Risk Management guidance -Review Document Note: This document is not a replacement for the IEC 60601 -1 or ISO 14971 standard, and does not include the full text of any referenced clauses or requirements, so a purchased copy of th

MECA IEC 60601-1 Risk Management Guidance Document Rev 1 MECA IEC 60601-1 Risk Management Guidance Document

  Management, Guidance, Risks, Risk management, 60601, Iec 60601, Risk management guidance