Purchaser Standards

July 03, 2013

General

Ontario Electrical Safety Code (OESC)

CSA SPE-1000,  2009 Model Code for the Field Evaluation of Electrical Equipment

CSA SPE-2000, 1994 Guide for Electrical Equipment for Installation and Use in Canada

CSA C22.1-09  Canadian Electrical Code, Part I, Safety Standard for Electrical Installations

CSA C22.2 No. 0-10 General requirements - Canadian Electrical Code, Part II

ISO 8601/CSA standard YYYY-MM-DD

CAN/CSA-C22.2 No. 950 or UL 1950 Safety of Information Technology Equipment

ISO 9001:2008 ISO Quality Systems – Model for quality assurance in design, development, production, installation, and servicing

Personal Health Information Protection Act (Ontario) (“PHIPA”) and the Personal Information Protection and Electronic Documents Act (Canada) including containing, where a Product is expected to store any personal health information, functionality that will allow SickKids to comply with access logging and so called “lock box” requirements of PHIPA.

Medical Equipment – Additional Requirements

CAN/CSA-C22.2 No. 60601-1:08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

CAN/CSA-C22.2 No. 60601-1-2:08 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:   Electromagnetic compatibility - Requirements and tests

CAN/CSA-C22.2 No.61010-1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use

IEC 80001-1:2010  Application of risk management for IT networks incorporating medical devices – Part 1: Roles, responsibilities and activities

Medical Devices (Equipment and/or Software) – Additional Requirements

HL7 v 2.3.1 Version 2.3.1 of the Health Level Seven (HL7) Standard for electronic data exchange in all health care environments

Health Protection Branch (HPB) registered for sale and use in Canada as a medical device (to be maintained for life of Product)