Safety & Compliance Forum

Health Canada may decide to stop using the 2nd Edition by Q4 2008. Device submissions to Health Canada prior to this tentative date will not be withdrawn.The cETL Mark will not be withdrawn for several years, and only if the device ismodified. You may start using the 3rd Edition now for both the cETL Mark and Health Canada. FDA and Health Canada are discussing a common effective date, which may cause Health Canada to extend their transition period.

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.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

NOTE: See also 4.2.

This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).

1.2 Object

The object of this standard is to specify general requirements and to serve as the basis for particular standards.

1.3 * Collateral standards

In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to:

- a subgroup of ME EQUIPMENT (e.g. radiological equipment);

- a specific characteristic of all ME EQUIPMENT not fully addressed in this standard.

Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.

NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards.

NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation.

NOTE 3 Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published.

If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard.

1.4 * Particular standards

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

NOTE: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published.

A requirement of a particular standard takes priority over this standard.

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. Identical to and reproduced from IEC 60601-1 Ed.3.1 (2012).

Summary of Topics

These editorial revisions to UL 60601-1 replace all references to UL 1020, the Standard for Thermal Cutoffs for Use in Electrical Appliances and Components, with reference to UL 60691, the Standard for Thermal-Links - Requirements and Application Guide. UL 1020 was withdrawn and superseded by UL 60691.