UL PRODUCT CATEGORY

Medical Equipment, PIDF


Guide Information for Electrical Equipment for Use in Ordinary Locations

517.45517.63(B)517.71517.75680.60680.61680.62(A)(1)680.62(A)(2)680.62517.45517.63(B)517.71517.75680.60680.61680.62(A)(1)680.62(A)(2)680.62

USE AND INSTALLATION

This category covers equipment intended to diagnose, treat, or monitor a patient under medical supervision, and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient.

This category also covers those accessories defined by the manufacturer as necessary for the normal use of the equipment.

Unless otherwise noted, this equipment is designed for professional use by qualified personnel in hospitals, nursing homes, medical care centers, medical and dental offices, and similar health care facilities, and in remote areas under the direction of qualified personnel, in accordance with the instructions specified by the manufacturer.

This equipment has been certified with respect to electric shock, fire, mechanical and other specified hazards incident to its use in unclassified locations. The other specified hazards are those that are included in UL 60601-1 (formerly UL 2601-1) and the Particular and/or Collateral Standards to which the equipment has been investigated.

The wiring methods for installation of these products are covered by Article 517 of ANSI/NFPA 70, "National Electrical Code" (NEC). The individual units of a system may be designed to be interconnected by means of one or more of the wiring methods outlined in the NEC.

The nature of some of this equipment, such as X-ray, nuclear imaging, and magnetic resonance equipment, is such that it involves features of installation and use not ordinarily presented in utilization equipment. Such features are covered in the manufacturer's installation instructions. Installation must, if possible, be made in a room or compartment in which provision is made to prevent fire or injury to persons and, in all cases, be in accordance with the manufacturer's installation instructions furnished with the equipment and the requirements of the Authorities Having Jurisdiction.

X-radiation safety and performance requirements are regulated under Public Law 90-602 and are enforced by the U.S. Department of Health and Human Services. These criteria are outlined in Code of Federal Regulations, Title 21, Parts 1000 to 1999. Compliance with the applicable regulations under the conditions of normal and abnormal operation has not been investigated by UL.

Some of the Medical Equipment certifications are predicated on the provision of one of two alternate attachment plugs specifically referred to in Attachment Plugs, Fuseless (AXUT). One is a locking type identified by the marking "Hospital Only" and the other is a nonlocking type ANSI Standard configuration grounding type identified by the marking "Hospital Grade" and a green dot on the body. The identification is visible after installation on the flexible cord.

Baby incubators and similar equipment for use with oxygen-enriched atmospheres have been investigated with respect to the increased hazard resulting from the presence of oxygen and electrical parts within the equipment. Motor-operated beds are marked if they are suitable for use with oxygen.

Oil bath sterilizers and similar equipment have been investigated with respect to their use with oils such as are recommended by the sterilizer manufacturer.

Individual components of the end products in this category have been investigated to applicable UL component requirements. Also, investigation of components to applicable international component requirements has been performed by UL or other appropriate certifying agency (as determined by UL). UL Follow-Up Service at the end-product manufacturing facility also determines that such components continue to bear the appropriate designated certifying agency's mark.

REBUILT PRODUCTS

This category also covers medical equipment that is rebuilt by the original manufacturer or another party having the necessary facilities, technical knowledge and manufacturing skills. Rebuilt medical equipment is rebuilt to the extent necessary by disassembly and reassembly using new or reconditioned parts. Rebuilt medical equipment is subject to the same requirements as new medical equipment.

FIELD-INSTALLED EQUIPMENT

Products covered under this category include equipment intended to be field installed, in accordance with the instructions provided, to certified equipment of the same manufacturer. Field-installed equipment is appropriately marked as noted below.

FACTORS NOT INVESTIGATED

The physiological effects, beneficial or otherwise, that may be produced by this equipment have not been investigated.

PRODUCT IDENTITY

One of the following product identities appears on the product:

    Field-installed Medical Equipment

    Medical Equipment

Other product identities may be used as shown in the individual certifications.


For rebuilt products, the word "Rebuilt," "Remanufactured," "Refurbished" or "Reconditioned" precedes the product identity.

RELATED PRODUCTS

Medical equipment that includes refrigerated components, such as refrigeration therapy equipment, is covered under Refrigerated Medical Equipment (SOPT).

Equipment investigated to determine its suitability for use in hazardous (classified) locations as defined in the NEC is covered under Medical Equipment for Use in Hazardous Locations (PINR).

For household health care equipment, see Personal Hygiene and Health Care Appliances (QGRZ).

For heating pads, see Heating Pads, Electric (MNUV).

ADDITIONAL INFORMATION

For additional information, see Electrical Equipment for Use in Ordinary Locations (AALZ).

REQUIREMENTS

The basic standard used to investigate products in this category is UL 60601-1 (formerly UL 2601-1),"Safety of Medical Electrical Equipment, Part 1: General Requirements." Note that although redesignated as UL 60601-1, UL 2601-1 is identical to UL 60601-1 except for formatting. Therefore, products identified as investigated to either standard are subject to identical technical requirements.

Particular StandardsUL 60601-1 contains requirements for safety which are generally applicable to all medical equipment. For certain types of equipment, these requirements are supplemented or modified by the special requirements of a Particular Standard (IEC 60601-2-XX). However, unless otherwise indicated in the deviations, the requirements of a Particular Standard do not modify the deviations. Where Particular Requirements exist, the General Standard is not used alone.

Collateral Standards — When the equipment falls within the scope of one or more Collateral Standards (IEC 60601-1-XX) such standard(s) may, optionally, also be used. Unless otherwise indicated in the deviations, the requirements of a Collateral Standard do not modify the deviations.

Product Marking (with respect to applicable standards) — As part of the Certification Mark, reference to UL 60601-1 and/or UL 2601-1 is included. For products that have been investigated to the applicable Particular (IEC 60601-2-XX) and/or Collateral (IEC 60601-1-XX) Standards, reference to these standards is made on the product or in the accompanying documents.

UL MARK

The Certification Mark of UL on the product is the only method provided by UL to identify products manufactured under its Certification and Follow-Up Service. The Certification Mark for these products includes the UL symbol, the words "CERTIFIED" and "SAFETY," the geographic identifier(s), and a file number.

Additional Certification Markings

Products covered under this category are additionally marked with the following information:

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH [standard*]
* Based on the certification coverage of the product, the standard may be UL 60601-1, UL 2601-1 or both, applicable Particular (IEC 60601-2-XX) and/or related Collateral (IEC 60601-1-XX) Standards for which the product has been found to comply by UL.


Alternate Marking Options



1. The Certification Mark includes the UL symbol, the words "CERTIFIED" and "SAFETY," the geographic identifier(s), a file number, the phrase "SEE ACCOMPANYING DOCUMENTS" or "IEC 348, Symbol 14 ," and the standard number*. At a minimum, the standard number* always includes UL 60601-1, UL 2601-1 or both. In addition, the product's accompanying documents will contain the complete Certification Mark as described above.
2. For products with limited space for markings, the Certification Mark includes the UL symbol, the words "CERTIFIED" and "SAFETY," and the IEC 348, Symbol 14 . In addition, the product's accompanying documents will contain the complete Certification Mark as described above.
3. For products (such as implantable devices) where the Certification Mark is not feasible, the complete Certification Mark will appear on the carton or on the smallest unit container in which the product is packaged. The product's accompanying documents may also contain the complete Certification Mark as described above.
* Based on the certification coverage of the product, the standard may be UL 60601-1, UL 2601-1 or both, applicable Particular (IEC 60601-2-XX) and/or related Collateral (IEC 60601-1-XX) Standards for which the product has been found to comply by UL.


Alternate UL Mark

The Classification Mark of UL on the product is the only method provided by UL to identify products manufactured under its Classification and Follow-Up Service. The Classification Mark for these products includes the UL symbol, the word "CLASSIFIED" above the UL symbol (as illustrated in the Introduction of this Directory), and the following additional information:

MEDICAL EQUIPMENT+
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH [standard*]
Control No.

+ or other appropriate product name as shown in the individual Classifications

For rebuilt or remanufactured products the word "Rebuilt,""Remanufactured,""Refurbished" or "Reconditioned" precedes the product name.

For field-installed products the words "Field Installed" precedes the product name.

Alternate Marking Options

1. The Classification Mark includes the UL symbol, the word "CLASSIFIED" above the UL symbol, the product name as described above, the phrase "SEE ACCOMPANYING DOCUMENTS," or the symbol of a triangle containing the exclamation point (IEC 348, Symbol 14 - ), the standard number* and a control number. As a minimum, the standard number* always includes UL 60601-1, UL 2601-1 or both. In addition, the product's accompanying documents will contain the complete Classification Mark.
2. For products with limited space for markings, the Classification Mark includes the UL symbol, the word "CLASSIFIED" above the UL symbol, the symbol of a triangle containing the exclamation point (IEC 348, Symbol 14 - ), and a control number. In addition, the product's accompanying documents will contain the complete Classification Mark.
3. For products (such as implantable devices) where the Classification Mark is not feasible, the complete Classification Mark will appear on the carton or smallest unit container in which the product is packaged. The product's accompanying documents may also contain the complete Classification Mark.

* Based on the certification coverage of the product, the standard may be UL 60601-1, UL 2601-1 or both, applicable Particular (IEC 60601-2-XX) and/or related Collateral (IEC 60601-1-XX) Standards for which the product has been found to comply by UL.

* * * * * * * * * * * * * * * * * * * * * * * * *

UL, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. UL shall not incur any obligation or liability for any loss, expense or damages, including incidental or consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Guide Information.

CTCT ScannersField-installed Medical EquipmentMagnetic Resonance ImagingMedical ImagingMRIMRI ScannersNuclear ImagingXrayX-ray
Last Updated on 2013-05-16
PIDF.GuideInfo PIDF Active 20130516 20060510

The appearance of a company's name or product in this database does not in itself assure that products so identified have been manufactured under UL's Follow-Up Service. Only those products bearing the UL Mark should be considered to be Certified and covered under UL's Follow-Up Service. Always look for the Mark on the product.

UL permits the reproduction of the material contained in the Online Certification Directory subject to the following conditions: 1. The Guide Information, Assemblies, Constructions, Designs, Systems, and/or Certifications (files) must be presented in their entirety and in a non-misleading manner, without any manipulation of the data (or drawings). 2. The statement "Reprinted from the Online Certifications Directory with permission from UL" must appear adjacent to the extracted material. In addition, the reprinted material must include a copyright notice in the following format: "© 2019 UL LLC".