CAN/CSA-C22.2 No. 60601-1-4:02 (R2011)

This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-1-4:1996+A1:1999. 1 Scope, object and relationship to other standards 1.201 Scope This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS). NOTE Some systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 60601-1 or the definition of MEDICAL ELECTRICAL SYSTEM in 2.203 of IEC 60601-1-1. 1.202 Object This Collateral Standard specifies requirements for the process by which a PEMS is designed. This Collateral Standard also serves as the basis of requirements of Particular Standards, including serving as a guide to SAFETY requirements for the purpose of reducing and managing RISK. This Collateral Standard is addressed to: a) certification bodies; b) MANUFACTURERS; c) writers of Particular Standards. This standard covers: d) requirement specification; e) architecture; f) detailed design and implementation including software development; g) modification; h) VERIFICATION and VALIDATION; j) marking and ACCOMPANYING DOCUMENTS. Aspects not covered by this standard include: k) hardware manufacturing; l) software replication; m) installation and commissioning; n) operation and maintenance; o) decommissioning.