mohamad hamad formulating antiseptic disinfectant items

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General Authority For Health Services For The Emirate Of Abu Dhabi Ref. No.: 30/60/014 Division/Dept/Section: Health Policies & Regulation Division Issue Date : June 2006 Subject: Policy/Procedure For Formulating Antiseptic/Disinfectant Items Revision Date: June 2008 Revision : 1 Policy/ Procedure for Formulating Antiseptic/ Disinfectant Items June 2006

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Page 1: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority For Health Services For The Emirate Of Abu Dhabi

Ref. No.: 30/60/014

Division/Dept/Section: Health Policies & Regulation Division Issue Date : June 2006

Subject: Policy/Procedure For Formulating Antiseptic/Disinfectant Items

Revision Date: June 2008

Revision : 1

Policy/ Procedure for Formulating Antiseptic/ Disinfectant Items

June 2006

Page 2: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority For Health Services For The Emirate Of Abu Dhabi

Ref. No.: 30/60/014

Division/Dept/Section: Health Policies & Regulation Division Issue Date : June 2006

Subject: Policy/Procedure For Formulating Antiseptic/Disinfectant Items

Revision Date: June 2008

Revision : 1

TABLE OF CONTENT

PAGE

1. INTRODUCTION 1

2. PURPOSE 1

3. APPLIES TO 1

4. DEFINITION 1

5. POLICY & PROCEDURE 1

6. SAFE USE OF ANTISEPTIC AND DISINFECTANT ITEMS 2

7. ATTACHMENTS 2

- Flow chart for formulating non-formulated antiseptic/ disinfectant items

- New product evaluation request form

- GAHS standard formulated list for antiseptic and disinfectant items - - GAHS Antiseptics/ Disinfectants technical committee members

Page 3: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority For Health Services For The Emirate Of Abu Dhabi

Ref. No.: 30/60/014

Division/Dept/Section: Health Policies & Regulation Division Issue Date : June 2006

Subject: Policy/Procedure For Formulating Antiseptic/Disinfectant Items

Revision Date: June 2008

Revision : 1

- 1 -

1. INTRODUCTION

It is essential to have the necessary approval for the use of any antiseptic/disinfectant agent at any of GAHS facilities, in order to provide effective and safe cleaning, disinfection or sterilization to the patient environment as well as to equipment involved in patient care.

2. PURPOSE;

The purpose of this policy is to ensure and provide general guidelines and description steps regarding how to formulate any antiseptic/disinfectant items in GAHS contract list.

3. APPLIES TO: GAHS Health Care Facilities, divisions and purchasing department. 4. DEFINITION:

Formulated item is an item that is recommended by GAHS antiseptic/disinfectant technical committee and listed in GAHS contract list after approval of the senior management.

5. POLICY & PROCEDURE:

5.1 Any antiseptic/disinfectant items requested for addition to a formulary list must be supported by documented clinical requirements, as well the following conditions:

Disinfectants should have broad-spectrum bactericidal, virucidal, fungicidal, and sporicidal

effects. Organic materials, soap, or plastics should not easily neutralize them. Antiseptic/disinfectant items should not lose efficiency in a short time and should have rapid

action. Preferably to be low corrosive and low irritant. Antiseptic/disinfectant items should be cost effective. Antiseptic/disinfectant items should also be environmentally friendly All antiseptic/disinfectant items/solutions must have an FDA (Food & Drug Administration)

in USA or CE (European Conformity) in European countries approval.

5.2 When the need for a new product is identified, the department/ facility should follow GAHS Purchasing and Material Management Policies and Procedures (605, 606 and 608).

Page 4: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority For Health Services For The Emirate Of Abu Dhabi

Ref. No.: 30/60/014

Division/Dept/Section: Health Policies & Regulation Division Issue Date : June 2006

Subject: Policy/Procedure For Formulating Antiseptic/Disinfectant Items

Revision Date: June 2008

Revision : 1

- 2 -

5.3 This approval will be forwarded to GAHS antiseptic/disinfectant technical committee, who will convene to determine and review the technical specification of each item and recommend accordingly.

5.4 After the recommendation of GAHS antiseptic/disinfectant technical committee the new

item will be forwarded to the Head of the Drug and Medical Product dept (GAHS) for approval and then it will be forwarded to purchasing committee for placement on price agreement.

6. SAFE USE OF ANTISEPTIC/ DISINFECTANT ITEMS:

All GAHS healthcare organizations must use antiseptic and disinfectant items according to the manufactures’ instructions and specifications.

All GAHS healthcare organizations must have Material Safety Data Sheet (MSDS) for each individual antiseptic/ disinfectant item.

Each unit have to prepare clear written guidelines/procedures for the safe and proper use of each individual antiseptic / disinfectant item that is in use in their unit and to be posted at the site of antiseptic / disinfectant use.

7. ATTACHMENTS

New Product Evaluation Request Form

Flow Chart for Formulating Non-Formulated Antiseptic/Disinfectant item

Antiseptics/ Disinfectants GAHS Formulated List

GAHS Antiseptics/ Disinfectants technical committee members

Page 5: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority For Health Services for the Emirate of Abu Dhabi

A~proved Document for Circulation

Description of DocumentlSerial Number: PPRllNSl002

Title of Document :

Purpose of the Document:

Originating Division & Department:

Origination Date:

Serial Number Assigned:

Version:

Review Date:

Policy/Procedures for formulating Antiseptic I Disinfectant ltems

To standardize Policy & Procedure for formulating Antiseptic I Disinfectant ltems and to have a standard list of Antiseptic & Disinfectant items for all the health care facilities of the Emirate of Abu Dhabi Provider Policy and Regulation Division (PPR) - Facility Licensing and lnspection Dept

June 2006

Version I

June 2008

DivisionIDepartment Responsible PPRl Facility Licensing & lnspection for Review:

Issue Date: October 2006 Number of Official Letter :

Approved Authorization: Document Submitted By: I Signature:

Ms. Khushnud Moul Team Leader, Hospitals & Clinics lnspection

Document Approved By:

Eng. Zaid D. A/ Siksek Director, Provider Policy and Regulation Division - Document Approved By: Signature: I

H. E. Ahmed Mubarak A1 Mazrouei 1 GAHS Director General

Page 6: Mohamad Hamad Formulating Antiseptic Disinfectant Items

General Authority for Health Services for the Emirate of Abn Dhabi

Management Support Division Quality & Risk Management Department

Antiseptic & Disinfectant Policy Task Force

3. Mr. Yasi. Al Ramahi Senior, Health & Safety Officer- GAHS

Appr~vaX Document

4. Dr. Mohd Abu A1 Khair brug Advisor- GAHS

5. Dr. Ninette Bandy Primary Care Specialist, Dentist- GAHS

No

, ,, - 6. Ms. Nancy Rhodes Planning Purchasing Analyse, GAHS

7. Ms. Elmalize Malan Purchasing Dept- GAHS

8. Ms. Margaret Lambert Senior Risk Officer- Tawam Hospital

I

1 1. Dr. Mokhtar El Hagrassy Chief of Microbiology- Mafiaq Hospital P - I

. , ' Signature Name

I

12. Mr. Mohd Hamad Senior LC. Coordinator- M a h q Hospital

13. Dr. Safinaz Khalil Microbiologist- Mafi-aq Hospital

T3t'le -

14. Mr. Kamal Khan Inventory Controller- SKMC . 1 5. Dr. Basheer Hamzeh Zlinical Pathologist- Western Region

f

v j ,,// ,...

Page 7: Mohamad Hamad Formulating Antiseptic Disinfectant Items

FLOW CHART FOR FORMULATING OF ANY ANTISEPTIC/DISINFECTANT INTO

THE FORMULARY LIST AT GAHS

The purpose of this flow chart is to ensure and provide general guidelines and description steps to all those responsible for antiseptics/disinfectants in GAHS facilities in order to be aware and familiar with the principle procedures for formulating any antiseptic/disinfectant solutions in the GAHS formulary list. For more details refer to Policy & Procedure for formulating antiseptic/disinfectant items.

Health Facility/Department Requesting

Non-formulary antiseptic/disinfectant items

The new product evaluation request form (Product Evaluation and Introduction of New Products- PUR 606) to be evaluated by new product evaluation committee

(PUR-608)

Health Facility Infection Control Committee and/or Material Management Evaluation Committee recommendation is required for the item requested

The recommendation of GAHS Hospital is forwarded to the GAHS

antiseptic/disinfectant technical committee for approval

Head of Drug and Medical product department in GAHS is needed

New approved item will be forwarded to purchasing department for

placement on the price agreement.

Page 8: Mohamad Hamad Formulating Antiseptic Disinfectant Items

GAHS STANDARD FORMULATED LIST FOR ANTISEPTICS DISINFECTANTS ITEMS

ITEM # ITEM DESCRIPTION CATALOG # FDA / CE MANUFACT COUNTRY

OF ORIGIN LOCAL VENDOR VENDOR LICENSED COMMENTS

ALCOHOL

1 Isopropyl Alcohol 70% (Isopropanol) 1000ml Esteer Pharma Germany Arabian Ethicals yes

2 Isopropyl Alcohol 70% (Isopropanol) 500ml Medline & EEC USA +Eur Global Int'l & Global Scientafic yes

3 Swabs Isopropyl Alcohol 70% 2 ply non- woven sterile Webcol MDS090730 MEDLINE USA Pharmalink yes

4 Swabs Isopropyl Alcohol 70% 2 ply Medium Sterile Webcol MDS090730 MEDLINE USA Pharmalink yes

Chlorhexidine Gluconate

1Hand Rub Composition: Alkylaminoalkyl glycine, ethanol, chlorexidine digluconate, allantoine, perfume (CHG 0.5 with Alcohol 70%)

Manuspray Anios France Gulf Drug Est. No

2 Hand Rub- CHG 0.5 with Alcohol 70% Antiseptica Germany Pharmalink yes

3 Aqueous CHG Solution 2% Esteer Pharma Germany Arabian Ethicals yes

4 Aqueous CHG Solution 2% 500ml Antiseptica Germany Pharmalink yes

5 Hand Scrub- CHG 4% Dermanios Anios France Gulf Drug Est. No

6 Hand Scrub- Aqueous CHG 4% Esteer Pharma Germany Arabian Ethicals yes

7 Hand Scrub- Aqueous CHG 4% 500ml Antiseptica Germany Pharmalink yes

8Scrub Brush Chlorhexidine Gluconate 4% Liquid for Hand Washing Scrub Brush 4% Exidine

4458A C.V MEDICA SPAIN Global Int'l yes

Povidone Iodine

1 Povidone Iodine 10% solution (1% Iodine) Aqueous Solution 120ml 10 8204 Triad USA Al Hayat yes

2 Povidone Iodine 10% solution (1% Iodine) Aqueous Solution EEC Europe Global Scientific yes

3 Swabs Povidone Iodine 10% solution (1% Iodine) Impregnated P.D.I. U.S.A/Europe Atlas yes

4 Swabsticks Povidone Iodine 10% solution (1% Iodine) Impregnated MDS093902 MEDLINE USA Global Int'l yes

5 Povidone/Iodine Prep Pads - Saturated with povidone/iodine 10%solution (1% iodine). Textured. MDS093917 MEDLINE USA Pharmalink yes

6

Povidone/Iodine Perineal Wash - A povidone-iodine 10% (1% Iodine) wash kit that includes an 8-ounce bottle of povidone-iodine solution and 8-ounce empty applicator bottle. Packaged as kits. – Povidone/Iodine wash kit

MDS093930 MEDLINE USA Pharmalink yes

FDA Stands for: Food Drug Administration - USACE Stands for: European Conformity - Europe

1Reviewed/ finalized by Antiseptic and Disinfectant Task Force 1/15/2007 nr

Page 9: Mohamad Hamad Formulating Antiseptic Disinfectant Items

GAHS STANDARD FORMULATED LIST FOR ANTISEPTICS DISINFECTANTS ITEMS

ITEM # ITEM DESCRIPTION CATALOG # FDA / CE MANUFACT COUNTRY

OF ORIGIN LOCAL VENDOR VENDOR LICENSED COMMENTS

7 Alphadine Scrub ( Scrubbing solution) Copmposition: Povidone Iodine 7.5% Surgical Reyad Pharma KSA Gulf Drug Est. No

Quaternary

1 Medicated Germicida (Quartenary) Hygiene Wipes Minuten Wipes 8062 APMD KSA Rekaz yesRequire clarificatio about its effectiveness (in process)

Antimicrobial Hand Sanitizer

1Hand Rub Purell 1000ml Composition: 62% Ethyl alcohol, Water (Aqua), Glycerin & Moisturizers

2156-04 Jojo Ind. USA Global Int'l yes

2

Hand Rub Manugel Hydroalcohol gel 500ml Composition: Hydro-alcoholic, 2-propanol basis (60%v/v) & antiseptic agent contains: viscousing & softening ingredients, Glycerin, perfume, coloring

1048363 LAB ANIOS France Gulf Drug yes

3Antimicrobial Hand Sanitizer Sterillium 500ml Composition: 2-propanol 45.0g,1-propanol 30.0g, mecetronium-etilsulfate (inn) 0.2g, skin care additive, colorant, fragrances

Bode Chemie Germany Horizon yes

4 Hand Rub Dial Instant 800ml Composition: 62% Ethyl alcohol, Water (Aqua), Carbomer, Disopropylamine, Cetyl Acetate, Glycerin & Moisturizers

Dial USA NMC yes

5 SURFACE WIPES DISINFECTANT DINGDI0099OCRequire manufact, vendor, country of origin & Composition (from GAHS)

6Chloraprep 2% (Sizes: 2.8mls, 3mls, 10mls & 26 mls) Skin Prep. Composition: Chlorhexidine2%

NoRequire manufact, vendor, country of origin & Composition (from GAHS)

7

Hand Scrub (Avagard).Composition: Chlorhexidine Gluconate 1% with Ethyl Alcohol 61% & Moisturizer 3M USA NMC No

CSSD

1 STERIS 20 Sterilant (for cleaning of gastro scopes) S2009 Steris USA Pharmatrade yes Composition is required (from GAHS)

2 Detergent Triple Enzyme Bacteriostatic 3M ZYME (Ultrasonic) Crti-Klenz - 1 gal 1479-08 Steris USA AMT yes Composition is required (from

GAHS)

3 Detergent Manual Detergent + Pre-Soak – Manu-Klenz 1 gal 1115-09 Steris USA AMT yes Composition is required

4 Instrument Corrosion Remover PRY CREAM-1 CASE - 12 OZ. NM430 Steris USA AMT yes Composition is required

FDA Stands for: Food Drug Administration - USACE Stands for: European Conformity - Europe

2Reviewed/ finalized by Antiseptic and Disinfectant Task Force 1/15/2007 nr

Page 10: Mohamad Hamad Formulating Antiseptic Disinfectant Items

GAHS STANDARD FORMULATED LIST FOR ANTISEPTICS DISINFECTANTS ITEMS

ITEM # ITEM DESCRIPTION CATALOG # FDA / CE MANUFACT COUNTRY

OF ORIGIN LOCAL VENDOR VENDOR LICENSED COMMENTS

5

Cidex OPA. Disinfectant 3.78LComposition: Ortho Phthal Aldhyde 0.55%, 99.45% water & inert ingredients 20391 J & J USA Pharmatrade yes

6 Detergent Triple Enzyme Bacteriostatic (Ultrasonic)3 ENZYME , 4 LITRE

MEDISAFE U.K. UK City Pharmacy yes Composition is required

7 Detergent Triple Enzyme Bacteriostatic 3M ZYME (Ultrasonic) ENDOZIME AW PLUS 345AP RUHOF USA MPC yes

8 Detergent Enzymatic ENDOZIME AW PLUS 345AP RUHOF USA MPC yes

9 Detergent Manual + Pre-Soak - Manu-Klenz - ENDOZIME AW PLUS 345AP RUHOF USA MPC yes

10 F A C T S Autoclave Cleaner 345FCT RUHOF USA MPC yes Composition is required

11 Remover Instrument Corrosion SURGISTAINE 345B RUHOF USA MPC yes Composition is required

12 Glutaraldehyde (Steranios) Composition: 2 % Glutaraldehyde (Activated) LAB ANIOS France Gulf Drug No

13

3E-Zyme (ANIOSYME 3000, 5 liter gallon)Composition: Enzymatic complex (protease, Lipase, amylase) and Stabilizing agent, Non ionic detergents, Polyhexanide, Quaternary ammonia propionate, Bactericidal, Virucidal, active against T.B.

LAB ANIOS France Gulf Drug Est

14 DETERGENT ENZYMATIC J & J USA PHARMATRADE YES

15Asepty ZymeProtease enzyme presoak,cleaner Reyad Pharma KSA Gulf Drug Est YES

HYDROGEN PEROXIDE

1Hydrogen Peroxide Cencentrate (1.62%PeraSafe)Composition: Peracetyl ions, Peracetic Acid 0.26%, hydrogen peroxide & acetic acid & decomposes to carbon dioxide & water

Antec Int'l /DuPont UK Metromed No

2Hydrogen Peroxide Surfactant (1% Virkon)Composition: Peracetyl ions, Peracetic Acid 0.26%, hydrogen peroxide & acetic acid & decomposes to carbon dioxide & water

Antec Int'l /DuPont UK Metromed No

DIALYSIS

1

Puristeril Plus or Actril (for cleaning and cold disinfection of heamodylisis machine)Composition: Peracetic Acid, Acetic Acid, Hydrogen Peroxide, water

67197-472DFeresenius Medical Care AG

Germany Feresenius Medical Care AG yes

the three items are under the same catalog No.345AP

FDA Stands for: Food Drug Administration - USACE Stands for: European Conformity - Europe

3Reviewed/ finalized by Antiseptic and Disinfectant Task Force 1/15/2007 nr

Page 11: Mohamad Hamad Formulating Antiseptic Disinfectant Items

GAHS STANDARD FORMULATED LIST FOR ANTISEPTICS DISINFECTANTS ITEMS

ITEM # ITEM DESCRIPTION CATALOG # FDA / CE MANUFACT COUNTRY

OF ORIGIN LOCAL VENDOR VENDOR LICENSED COMMENTS

2Diasteril (for cleaning and heat disinfection of heamodylisis machine) Composition: 21.3gm of Hydoxy Acetic Acid/100ml

# 5085651Feresenius Medical Care AG

Germany Feresenius Medical Care AG yes

3Deconex Neutralizer (for special washing machine, for neutralizing of alkaline residues) Composition: Phosphate free, based on Organic Acid

Al Kevin Trading Switzerland Al Kevin Trading No

Hypochlorite & Sodium Dichloroisocyanurate (N.A.D.C.)

1 Disinfectant Sodium Hypochloride Solution Clorox Bleach Solution 5.25% yes Require manufact, vendor

& country of origin

2 Hypochlorite Achtichlor: Tablet & Granules Tablet 0.5 Gm and 2.5 Grams.Disinfectant

DePuy Health Care UK Al Amry Medical No

3 Hypochlorite Presept: Tablet & Granules Tablet 0.5 Gm and 2.5 Grams.Disinfectant J & J USA Pharmatrade No

4 Germicide White Vinegar Solution yesRequire manufact, vendor, country of origin & Composition.

DENTAL

1DISINFECTANT SOLUTION FOR INSTRUMENT BIOMERS NON CORROSIVE SAFER REDY TO USE,RECHED HIGHEST LEVEL TB DISINFECTION IN ONE MINUTE

MICRYLIUM CANDA Al Nawras yes Composition is required

2

BIOSONIC CLEANING SOLUTION FOR ULTRASONIC BATH ULTRACLEAN-3 (DISINFECTANT CONCENTRAT FOR THE ULTRASONIC BATH, EXCELLENT CLEANING EFFECT DISSOLVES PROTEINS ON CONTAMINATED INSTRUMINT REMOVES GIPS,CEMENT,BLOOD,

MICRYLIUM CANDA Al Nawras yes Composition is required

3 INSTRUMENT DETERGENT DISINFECTOR POWDER FOR ALUMINIUM TRAY NEODISHER AN MILD KG WEGERT GERMANY Al Nawras yes Composition is required

4

DISINFECTANT SOLUTION FOR INSTRUMENT FREE ALDEHYDES, PHENOL AND CORROSIVE ,EFFECTIVE SPECTRUM: BACTERICIDE/FUNGICIDE/MRSA,TUBERCULOCIDE, HEPATITIS B & C, NON -ENVELOPED ADENO VIRUS, AND THE ONLY ONE EFFECTIVE ON CORONAVIRUS(SARS) OROCID MULTISEPT PLUS

ORO CLEAN CHEMI AG

SWITZERLAND MED PLANET yes Composition is required

5

DISINFECTANT SOLUTION FOR SURFACE DETRIRO MIKRO WITH SPRAYER ALDEHYDE FREE MINIMAL ALLERGY RISK, VERY SHORT WORKING TIME (30SECONDS) EFFECTIVE SPECTRUM: EFFECTIVE SPECTRUM: BACTERICIDE/FUNGICIDE/MRSA,TUBERCULOCIDE, HEPATITIS B & C PLEASANT LIME SCENT

ORO CLEAN CHEMI AG

SWITZERLAND MED PLANET yes Composition is required

FDA Stands for: Food Drug Administration - USACE Stands for: European Conformity - Europe

4Reviewed/ finalized by Antiseptic and Disinfectant Task Force 1/15/2007 nr

Page 12: Mohamad Hamad Formulating Antiseptic Disinfectant Items

GAHS STANDARD FORMULATED LIST FOR ANTISEPTICS DISINFECTANTS ITEMS

ITEM # ITEM DESCRIPTION CATALOG # FDA / CE MANUFACT COUNTRY

OF ORIGIN LOCAL VENDOR VENDOR LICENSED COMMENTS

6

BIOSONIC CLEANING SOLUTION FOR ULTRASONIC BATH ULTRACLEAN-3 (DISINFECTANT CONCENTRAT FOR THE ULTRASONIC BATH, EXCELLENT CLEANING EFFECT DISSOLVES PROTEINS ON CONTAMINATED INSTRUMINT REMOVES GIPS,CEMENT,BLOOD,

ORO CLEAN CHEMI AG

SWITZERLAND MED PLANET yes Composition is required

7

SURFACE WIPES DISINFECTANT FREE ALDEHYDES, PHENOL AND CORROSIVE ,EFFECTIVE SPECTRUM: BACTERICIDE/FUNGICIDE/MRSA,TUBERCULOCIDE, HEPATITIS B & C, NON -ENVELOPED ADENO VIRUS, CORONAVIRUS(SARS) DENTIPO WIPES (FAST DISINFECTANT OF SMALL SURFACES, EGUIPM

ORO CLEAN CHEMI AG

SWITZERLAND MED PLANET yes Composition is required

8EVACUATION SYSTEM CLEANER SOLUTION OROCLEAN LIQUID CONCENTRATE NON FOAMING CLEANING FOR EVACUATION SYSTEM.

ORO CLEAN CHEMI AG

SWITZERLAND MED PLANET yes Composition is required. Used

for Dental Unit

9 REACTIVATION SALT FOR WASHER DISINFECTOR MACHINE REACTIVATION SALT FOR WASHER DISINFECTOR MACHINE IKZONOBEL NETHERLAN

D Al Nawras yes Composition is required

10 TRAY CLEANER POWDER Coe tray cleaner detergent powder cleaning agent for impression tray G.C Europe Gulf& World yes Composition is required

11 IMPRESSION DISINFECTANT LIQUID CONCENTRATE MD 520, Imprission Disinfection liquid for use with HygoJet, 2.5 ltr. Durr Dental Germany G.M.P yes Composition is required

12EVACUATION SYSTEM CLEANER SOLUTION Durr - Germany - OROTOL Classic, 1Ltr of concentrated liquid produce 20 Ltr. Working solution ( 5% )

Durr Dental Germany GULF MED PROJ yes Composition is required

13 MIXER,FOR EVACUATION CLEANER Durr Dental - Germany, OROCAP Durr Dental Germany GULF MED PROJ yes Composition is required

14 MIXER,FOR EVACUATION CLEANER Durr Dental Durr Dental Germany PRIME yes Composition is required

FDA/CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant USA / European health, safety and environmental protection legislations.

Total Items: 65

CE - European Conformity - European Countries

FDA Stands for: Food Drug Administration - USACE Stands for: European Conformity - Europe

5Reviewed/ finalized by Antiseptic and Disinfectant Task Force 1/15/2007 nr