Medical Electrical Equipment Part 2: Particular Requirements for Safety of Transport Incubators
|Publication Date:||1 December 1990|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
Scope and object
Replace the text of this subclause by the following:
This Particular Standard specifies safety requirements for TRANSPORT INCUBATORS, as defined in 2.1.101 of this standard.
This standard does not apply to baby incubators (see IEC 601-2-19)
This Particular Standard refers to IEC 601-1: 1988, Medical electrical equipment - Part 1: General requirements for safety with its amendments 1 (1991) and 2 (1995).
For brevity, IEC 601-1 is referred to in this Particular Standard either as the "General Standard" or as the "General Requirements".
The term "this Standard" is used to make reference to the General Standard and this Particular Standard taken together.
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, etc., and additional items aa), bb), etc.
Where there is no Corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard applies without modification.
A requirement of this Particular Standard replacing or modifying requirements of the General Standard takes precedence over the corresponding General Requirement(s).
Add the following new text:
The following Collateral Standards apply:
IEC 601-1-1: 1992, Medical electrical equipment - Part 7: General requirements for safety - 7. Collateral standard: Safety requirements for medical electrical systems
IEC 601-1-2: 1993, Medical electrical equipment - Part 7: General requirements for safety - 2. Collateral Standard: Requirements and tests
IEC 601-1-3: 1994, Medical electrical equipment - Part 7: General requirements for safety - 3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 601-1-4: 1996, Medical electrical equipment - Part I: General requirements for safety - 4. Colla feral Standard: Programmable electrical medical systems