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CAN/CSA-C22.2 NO. 60601-2-8-01(R2009)

Medical Electrical Equipment - Part 2-8: Particular Requirements for the Safety of Therapeutic X-Ray Equipment Operating in the Range 10kV to 1MV (Adopted CEI/IEC 60601-2-8:1987 + A.1:1997, edition 1.1, 1999-04) / Appareils électromédicaux - Partie 2-8: Règles particulières de sécurité pour les équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10kV à 1 MV (norme CEI/IEC 60601-2-8:1987 + A.1:1997 adoptée, édition 1.1, 1999-04)

SKU: 2414473 Published by CSA Group Publication Year 2001 Reaffirmed in 2009 79 pages Withdrawn

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Preface/Scope

Scope

This clause of the General Standard applies except as follows:

1.1 Scope
Addition: This Particular Standard applies to therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kv to 1 MV when connected to alternating current SUPPLY MAINS.

1.2 Object
Replacement: This Particular Standard establishes requirements for the safety of therapeutic X-RAY EQUIPMENT including the requirement for accuracy and reproduciblility of performance to the extent that these are related to RADIATION QUALITY and the quantity of IONIZING RADIATION produced and thus must be considered as aspects of safety.

An object of this Particular Standard is to present the general functional requirements of the demand for safety, rather than any particular technological means of implementation.

1.3 Particular Standards
Additional subclauses:

1.3.101 Relation to the General Standard
This Particular Standard shall be read in conjunction with IEC 60601-1 (1998) and its amendments 1 (1991) and 2 (1995).

As in the General Standard, the requirements of this Particular Standard are followed by compliance tests.

The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are SPECIFIED by the use of the following words:

Replacement means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.

Addition means that the text of this Particular Standard is additional to the requirements of the General Standard.

Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.

The term this Standard is used to make reference to the General Standard and this Particular Standard taken together.

A requirement of this Particular Standard is replacing or modifying requirements of the General Standard takes precedence over the corresponding General Requirement(s).

Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification. Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. Unless otherwise stated, all clauses of the General Standard shall apply.

1.3.103 IEC 61217
This Standard defines the designation of EQUIPMENT movements, the marking of scales, their zero positions, and the direction of movements with increasing values.

1.5 Collateral Standards

1.5.101 IEC 60601-1-1
This Collateral Standard does not apply.

1.5.102 IEC 60601-1-2
ELECTROMAGNETIC COMPATIBILITY (EMC) - Requirements and tests: see clause 36.

1.5.103 IEC 60601-1-3
This Collateral Standard does not apply.

1.5.104 IEC 60601-1-4
NOTE - The Collateral Standard IEC 60601-1-4 and/or a future amendment to the General Standard, with a consequent amendment to this Particular Standard, will provide a comprehensive treatment of all safety aspects of PROGRAMMABLE ELECTRONIC SYSTEMS used in therapeutic X-RAY EQUPMENT.
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Domaine d’application

L'article correspondant de la Norme Générale s'applique qvec les exceptions suivantes:

1. Domaine d’application
Complément: La présente Norme Particulière s'applique aux EQUIPEMENTS À RAYONNEMENT X de thérapie fonctionnant a des HAUTES TENSIONS NO

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CAN/CSA-C22.2 NO. 60601-2-8-01(R2009)

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CAN/CSA-C22.2 NO. 60601-2-8-01(R2009)

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