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435/40-01b

Texas Specification No. 435-40-01B

Effective Date: February 5, 1992

Reformatted Date: June 28, 1996

SPECIFICATION

for

DISINFECTANT DETERGENT, IODOPHOR TYPE

1. SCOPE: This specification establishes the minimum requirements for a non-selective iodophor type germicide, in concentrated liquid from, for use as a disinfectant, sanitizer and/or cleaner to control pathogenic organisms on surfaces in a health care environment.

2. APPLICABLE SPECIFICATIONS AND STANDARDS: Reference to specifications, standards, test methods, and other documents shall be to the issues in effect on the date of the Invitation for Bids. Copies of the referenced documents may be obtained from the issuing organizations at the addresses shown. The following publications form a part of this specification to the extent specified herein:

2.1. ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS (AOAC), 2200 Wilson Boulevard, Arlington, VA 22201:

2.1.1. Official Methods of Analysis -- Fifteenth Edition 1990.

2.2. FEDERAL DOCUMENTS, Superintendent of Documents, U.S.Government Printing Office, Washington, DC 20402:

2.2.1. A-A-1440 -- Disinfectant Detergent, General Purpose (Iodophor).

2.2.2. Code of Federal Regulations -- 16 CFR 1500: Hazardous Substances and Articles.

2.2.3. Code of Federal Regulations -- 29 CFR 1910: Occupational Safety and Health Standards.

2.2.4. Code of Federal Regulations -- 40 CFR Chapter 1: Environmental Protection Agency (EPA).

2.2.5. Code of Federal Regulations -- 40 CFR 164: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

2.3. NATIONAL FIRE PROTECTION ASSOCIATION (NFPA), One Batterymarch Park, Quincy, MA 02269:

2.3.1. NFPA 99 -- Health Care Facilities.

2.4. U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA), Washington, DC 20460:

2.4.1. DIS/TSS-7 -- Vircuides, February 6, 1979.

2.5. UNDERWRITERS LABORATORIES, INC. (UL), 333 Pfingston Road, Northbrook, IL 60062:

2.5.1. Hazardous Location Equipment.

3. CLASSIFICATION: The disinfectant solution shall be classified by a minimum iodine percentage of 1.6%.

4. DEFINITIONS: Terminology used in this specification is intended to be generic in nature and consistent with meanings that have been defined through general use and/or accepted trade practices. Where variant meanings may exist, the applicable interpretation shall be determined by the Texas Procurement and Support Services.

4.1. Commission: Texas Procurement and Support Services.

4.2. LD50: The probable lethal dose of undiluted product to fifty percent (50%) of the test animals, when determined from Ingestion Studies.

4.3. Use Dilution: The amount added to water, as recommended on the product label, which provides a minimum of 75 ppm titratable iodine.

5. REQUIREMENTS: Products furnished under this specification shall meet or exceed the following requirements:

5.1. General Requirement: The product shall be a non-staining concentrated liquid, having an amber color (which depends on the iodophor). It shall provide non-selective action against all major classes of microorganisms, including bacteria, fungi, and viruses and not be inactivated by blood, pus, or serum. The use dilution shall provide germicidal action when used in hard, soft or cold water. There shall be no colorants other than iodine. It shall be non-toxic, non-irritating, have a stable shelf life, not exhibit a flash point, and be non-combustible.

5.2. Chemical Composition and Properties: The disinfectant shall contain iodine in complex from with sufficient iodophor (iodine-carrier) to from a stable water soluble complex. The solution shall furnish a minimum titratable iodine content of 1.6%, wt/vol. Test in accordance with Paragraph 6.1. It shall be complexed with a nonionic synthetic detergent.

5.3. Registration: The disinfectant detergent shall be registered with the Environmental Protection Agency (EPA) under the provision of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Environmental Pesticide Control Act.

5.4. Germicidal Effectiveness: The use dilution solution shall be microbicidal to a broad spectrum of organisms and vegetative bacterial strains when tested in accordance with Paragraph 6.2. The test organisms shall include the following bacterial species as a minimum:

Staphylococcus aureus ATCC # 6538

Salmonella choleraesuis ATCC # 10708

Pseudomonas aeruginosa ATCC # 15442

5.5. Tuberculocidal Effectiveness: The use dilution solution shall be tuberculocidal for Mycobacterium tuberculosis var. Bovis (BCG) when tested in accordance with Paragraph 6.2.

5.6. Fungicidal Effectiveness: The use dilution solution shall be fungicidal for Trichophyton mentagrophytes (ATCC # 9533) as a minimum when tested in accordance with Paragraph 6.2.

5.7. Virucidal Effectiveness: The use dilution solution shall be virucidal for Herpes simplex, Vaccinia, and Influenza A2 when tested in accordance with Paragraphs 6.2. and 6.5.

5.8. Hard Water Conditions: The use dilution solution shall be effective as a disinfectant against all organisms listed above in hard water containing 400 ppm of hardness as calcium carbonate (AOAC).

5.9. Toxicity: The concentrated solution shall have an Acute Oral Toxicity Value (LD50) of more than five (5) mg/kg body weight (non-toxic) when tested in accordance with Paragraph 6.3.

5.10. Skin Irritancy: The strongest use dilution recommended on the product label shall not be a primary skin irritant or sensitizer when tested in accordance with Paragraph 6.4.

5.11. Storage Stability: The product shall show no loss of antimicrobial action after one (1) year of storage at temperatures in the range 50 -- 86 F. The use dilution shall show no tendency to from a precipitate or to stratify.

5.12. Odor: The recommended use dilution shall have no disagreeable odor.

5.13. Residue (Rinsability): The recommended use dilution shall leave no residue after rinsing with hard water.

5.14. Detergent Action: The use dilution solution shall provide sufficient detergent action without the addition of soap or other cleaners. It shall not damage any surface when used as recommended.

5.15. Effect of Conductive Floorings: When conductive flooring which meets the requirements of NFPA 99 is washed with the use dilution of the product and allowed to dry without rinsing, it shall still meet the conductivity requirements of NFPA 99. Alternatively, the product may be classified by Underwriters Laboratories, Inc. (UL) as a "Floor Cleaner Relating to Hazardous Locations (ILQV)".

6. TESTING: Testing shall be done by, or at the direction of, the Commission and/or the receiving State agency. Tests shall be performed on products from shipments to ordering agencies. In the event products tested fail to meet or exceed all conditions and requirements of this specification, the cost of the samples are used and the cost of testing shall be borne by the supplier.

6.1. The products furnished under this specification shall be tested by the following methods or approved equally applicable procedures:

6.1.1. Titratable Iodine: Titrate with standard sodium thiosulfate solution by a conventional iodometric procedure.

6.1.2. Germicidal Effectiveness: Perform in-vitro testing by the use dilution method of AOAC, in the presence of 5% blood serum.

6.1.3. Toxicity: Determine LD50 with white rats by the method of 16 CFR 1500.3, issued by the Consumer Product Safety Commission.

6.1.4. Skin Irritancy: Determine compliance with 16 CFR 1500.3 by the skin patch test.

6.1.5. Virucidal Effectiveness: Test in accordance with EPA DIS/TSS-7.

6.1.6. Certification: When so specified in the Invitation for Bids, the vendor shall provide technical data sheets from the manufacturer showing material safety data (use OSHA form) and test data.

7. SAMPLES: When so specified in the Invitation for Bids, no prepurchase samples shall be required. Samples tested shall be obtained from products supplied on regular orders.

8. INSPECTION: Products furnished under this specification shall be inspected by, or at the direction of, the Commission and/or the ordering State agency either at the destination or place of manufacture.

9. WARRANTY: All disinfectant detergent shall carry the manufacturer's standard warranty and shall be guaranteed against defects for a minimum of one (1) year. The warranty shall begin on the date of acceptance of the unit by the ordering agency. During this warranty period, the vendor shall replace defective components and/or units at no cost to the State of Texas.

10. PACKING and/orPACKAGING: Packaging for shipment shall be in accordance with the manufacturer's standard practice and in a manner readily accepted by common carriers engaged in interstate commerce. Within the shipping carton, units shall be packed in a manner designed to minimize damage during shipment due to rough or improper handling.

10.1. Container Size: The product shall be furnished in one or more of the following size containers or as specified in the Invitation for Bids.

10.1.1. One (1) gallon containers, four (4) per case.

10.1.2. Fifty-five (55) gallon drums.

10.2. Container Material: There shall be no reaction between the container and the product.

11. MARKING and/or LABELING:

11.1. Marking: Each shipping container shall be clearly marked with:

11.1.1. Name of contents.

11.1.2. Quantity.

11.1.3. Name and address of the manufacturer.

The container or shipping documents shall include:

11.1.4. Order number or contract number

11.1.5. Name and address of ordering agency.

11.1.6. Agency requisition number.

11.2. Labeling: Each product container shall bear a securely affixed and durable label. Each product container label shall fully conform to the requirements of the EPA and the FIFRA including the following information:

11.2.1. Name of the product, including brand name, if any.

11.2.2. Net contents, in U.S. liquid measure.

11.2.3. Active ingredients, precautionary statements, and other data as required by FIFRA.

11.2.4. EPA Registration Number.

11.2.5. Batch number.

11.2.6. The recommended use dilution (s) for the recommended disinfecting purpose (s).

11.2.7. Name and address of the manufacturer.

12. BID LITERATURE:; All bids shall be accompanied by a description of the products being offered.

12.1. Labels: The bidder shall submit one (1) product label with each item bid.

13. RELATIVE COST: The relative cost shall be determined on the basis of the use dilution. The formula for determining the relative cost (RC) per gallon is calculated as follows:

RC = C x Vc

V

Where: Vc = Volume in ounces of concentrate as required to produce one (1) gallon of the use dilution.

C = Cost per gallon of concentrate.

V = Volume in ounces of the container.

When so specified in the Invitation for Bids, the bidder shall submit the relative cost with the bid.

14. COMPLIANCE: In order for consideration to be given to the bid on an item under this specification, the bidder must comply with the following conditions.

14.1. Equipment Identification: The make, model number, name of the manufacturer, brand or trade name, etc., as applicable, of the item which the vendor proposes to furnish must be state as part of the bid.

14.2. Exceptions: Notwithstanding the above, any exception taken by the bidder to the requirements and conditions of this specification must be stated and described in detail as a part of the bid. If no exceptions or deviations are identified in this manner, the items must be furnished exactly as described herein.

14.3. Proof: The bidder shall bear the burden of proof of compliance with this specification.

15. PRODUCT INFORMATION: Iodophor type disinfectant detergents are intended for rapid, non-selective action against pathogens to protect patients from infection.

15.1. Surfaces: The solution is effective on most hospital surfaces. The effectiveness is lessed by the presence of heavy soil which should first be removed.

15.2. Use-Dilution: The manufacturer's use dilution and application recommendations should be followed carefully. When loss of amber color occurs, the use dilution should be discarded. Do not mix this type of disinfectant with any soap or cleaning product.

15.3. Health Hazards: The concentrated product is irritating to eyes and mucous membranes. Protective gloves and eye protection are recommended.

16. ORDERING DATA: When ordering products conforming to this specification, the requisitioning agency shall specify the following:

16.1. The number of this specification (435-40-01B),

16.2. Size container (s) desired (See Paragraph 10.1.).

16.3. Quantity of each size container required.

17. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by writing or calling:

Bid Services
Texas Procurement and Support Services
P. O. Box 13186
Austin, TX 78711-3047
(512) 463-3411

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