Safety & Compliance Database

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For copies of Standards, please contact the appropriate agency. PSMA does not provide copies of standards.
Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
CSA Group
CAN/CSA C22.2 No. 60601-1-08 - Start year: 2008
Location: Americas - Canada

Description:

Canada has published their national version of IEC 60601-1 (3rd Edition) asCAN/CSA C22.2 No. 60601-1-08.

The objective of Standards issued as part of the Canadian Electrical Code, Part II, is to give consideration to the prevention of injury to persons and damage to property through proper design, good construction, and high quality of work. These safety Standards are intended to provide requirements for the design and construction of electrical equipment, primarily to address fire and electrical shock hazards and for use throughout Canada in conformity with the rules of the Canadian Electrical Code, Part I.

The objective of Standards issued as part of the Canadian Electrical Code, Part II, is to give consideration to the prevention of injury to persons and damage to property through proper design, good construction, and high quality of work. These safety Standards are intended to provide requirements for the design and construction of electrical equipment, primarily to address fire and electrical shock hazards and for use throughout Canada in conformity with the rules of the Canadian Electrical Code, Part I.

Notes:

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 Device submissions to Health Canada prior to this tentative date will not be withdrawn.The cETL Mark will not be withdrawn for several years, and only if the device ismodified.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.

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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
CSA Group
CAN/CSA-C22.2 NO. 60601-1:14 - Start year: 2014
Location: Americas - Canada

Description:

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, third edition, 2005-12, including amendment 1:2012, with Canadian deviations) | Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (norme CEI 60601-1:2005 adoptée, troisième édition, 2005-12, y compris l'amendment 1:2012, avec exigences propres au Canada)

Notes:

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.

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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
International Electrotechnical Commission
IEC 60601-1 - Start year: 1977/AMD1:1984 Withdrawn
Location: Global - Global

Description:

The general requirements of 60601-1 apply to all medical electrical equipment and part 2 standards apply to specific categories of medical electrical equipment. However, there is another level in this hierarchy of standards: the collateral standards. These are applied more selectively than the general requirements, either in terms of the topic they cover or the type of equipment, but they are not as specific as the part 2 standards. In standards jargon they are referred to as semi-horizontal standards.

Notes:
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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
Japanese Standards Association
JIS t 0606-1-2:2012
Location: Japan - Japan

Notes:
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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
Standards New Zealand
AS/NZS IEC 60601.1:2015 - Start year: 2015
Location: Asia/Pacific - New Zealand, Australia

Description:

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Notes:

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).

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