UL 2601-1:2000 pdf download Medical Electrical Equipment, Part 1: General Requirements for Safety
1 Scope and object
1.1Scope
Add the following text in place of the sentence “SAFETY HAZARDS resulting from …
SAFETY HAZARDS resulting from intended physiological function of EQUIPMENT covered by this Standardare not considered These reauirements do not contemplate the investication of protection aaainst ionizingradiation or radioactive isotopes. Such EQUIPMENT is subject to Federal radiation Standards (21CFR Part1020) promulgated under the Radiation Control for Health and Safety Act of 1968
New 2.10.100 and 2.10.101
To reflect definitions in the NEC add the following to this sub-clause.2.10.100X-RAY INSTALLATIONS(LONG-TIME RATING)
A rating based on an operating interval of 5 minutes or longer2.10.101X-RAY INSTALLATIONS (MOMENTARY RATING)
A rating based on an operating interval that does not exceed 5 seconds.2.12Miscellaneous
Add the following definitions:
2.12.100PATIENT CARE EQUIPMENT
EQUIPMENTintended for use in or likely to be used in the PATIENT VICINITY.
2.12.101PATIENT VICINITY
In areas in which patients are normally cared for, the patient vicinity is the space with surfaces likelto be contacted by the patient or an attendant who can touch the patient This encloses a space withinthe room 1.83 m (6 feet) beyond the perimeter of the bed (examination table, dental chair, treatmentbooth, and the like)in its intended location, and extending vertically 2.29 m (7-1/2 feet) above the floor.
2.12.102
An Internationally Harmonized Component Standard is a standard satisfying U.S. national andinternational safety concerns and may include national deviations (exceptions) which modifythe requirements of the relevant internationally recognized safety standard, (such as anIEC/SO standard). When necessary, due to national safety concerns, the national deviationsmay include the unique U.S. national safety, regulatory, and legal requirements taken fromthe relevant nationally recognized safety standard (such as an ANSI/UL standard).
3 General requirements
To explain the intended method of evaluation of components add the following new sub-clauses to this clause.
3.100 Components
3.100.1 ln addition to compliance with this standard, the following components shall meet nationally recognizedstandards (such as ANSI/UL standards) or internationally harmonized component standards:
a) Printed wiring boards
b) Lithium batteries
c) Optical isolators
d) Wiring and Tubing
e) CRTs > 5 inches
Exception: ltems a), c) and d) are exempt from this requirement if they are connected totally in an SELV circuitimited to 15 W, or less, maximum available power and whose failure will not result in a SAFETY HAZARD.
3.101 Primary Circuit Components
3.101.1 ln addition to compliance with this basic standard, components in the primary circuit up to the isolationtransformer shall meet nationally recognized standards (such as ANSI/UL standards) or internationallharmonized component standards.
3.102Supplement A tabulates UL component Standards covering components as specified in sub-clauses3.100.1 and 3.101.