CSA C22.2 NO. 60601-1-12:15 (R2020) CONSOLIDATED

CSA Preface

This is consolidated edition 1.1 of CSA C22.2 No. 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-12 (edition 1:2014 consolidated with Amendment 1:2020). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as “CSA C22.2 No. 60601-1-12” throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations). Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence. This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope and object

1.1 Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1.

NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use. The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT. The EMS ENVIRONMENT includes

– responding to and providing life support at the scene of an emergency to a PATIENT reported as experiencing injury or illness in a pre-hospital setting, and transporting the PATIENT, while continuing such life support care, to an appropriate professional healthcare facility for further care.

– providing monitoring, treatment or diagnosis during transport between professional healthcare facilities. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within the scope of this standard. EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare facility environment.

NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical sources and outdoor environmental conditions.

1.2 Object The object of this collateral standard is to provide general requirements for ME EQUIPMENT and ME SYSTEMS carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.