CAN/CSA-C22.2 NO. 60601-2-38-03 (R2007):2003 Edition
$40.30
Medical Electrical Equipment – Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds (Including update no. up to 1:2006)
| Published By | Publication Date | Number of Pages |
| CSA | 2003 | 110 |
Scope and object
This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements for safety of ELECTRICALLY OPERATED HOSPITAL BEDS, hereinafter referred to as BED, as defined in 2.2.101.
1.2 Object
Replacement:
The object of this Particular Standard for BEDS is to keep the SAFETY HAZARDS to PATIENTS, OPERATORS, and the environment as low as possible, and to describe tests to verify that these requirements are attained.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter referred to as General Standard, consisting of IEC 601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety, amendment 1, amendment 2 and IEC 601-1-1: 1992, Medical electrical equipment – Part 1 : General requirements for safety – 1. Collateral Standard: Safety requirements for medical electrical systems.
For brevity, IEC 601-1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(s), and IEC 601-1-1 as the Collateral Standard.
The term this Standard covers the Particular Standard, used together with the General Standard and any Collateral Standards.
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.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk *. These rationales can be found in an informative annex AA. Annex AA should be used in determining the relevance of the requirements addressed, but should never be used to establish additional test requirements.
Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or the Collateral Standard applies without modification.
Where it is intended that any part of the General Standard or the Collateral Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General Standard or the Collateral Standard takes precedence over the corresponding General Requirement(s).
