Bulgaria – Antiseptics and disinfectants – Supply of disinfectants – by separate lots for the needs of UMBAL “SVETA EKATERINA” EAD

Opportunity description

The subject matter of the public procurement includes the supply of various types of antiseptic agents and disinfectants.

Surface disinfectant with aldehydes /without formaldehyde/ and quaternary ammonium salts – combined preparation Application: For treating floors, walls and furnishings in operating rooms, hospital wards, consulting rooms, corridors, elevators, sanitary facilities and patient-care items. Action: Simultaneous cleaning and disinfecting action. Main composition: With aldehydes (without formaldehyde) and quaternary ammonium salts – combined preparation, liquid concentrate. Properties of the working solution: Must not damage the materials from which the various types of surfaces are made; proven compatibility with a wide range of materials /linoleum, PVC, synthetic and acrylic materials, rubber, stainless steel, aluminum, chrome-plated parts. Effective at low concentration. With a light, non-irritating fragrance. Broad spectrum of action: bactericidal (incl. Tbc, MRSA), fungicidal, virucidal (HBV, HCV, HIV); also suitable for use with floor-cleaning machines. Must be easy to dose, with the corresponding dosing devices provided.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”.

Requirements for the disinfectants supplied and the participants: 1. The medical devices offered must comply with the requirements of the Medical Devices Act /MDA/ – this shall be declared in the participant’s technical proposal; 2. Disinfectants that are medical devices must have a Declaration of Conformity for the medical devices offered/Certificate or equivalent documents of conformity with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body within the meaning of the MDA /or equivalent/ – submitted with the technical proposal where applicable; 3. The medical device must have a Quality Certificate – CE marking, in accordance with the applicable EU directive /or equivalent/ – submitted with the technical proposal where applicable; 4. For disinfectants that are biocides, the participant must submit an authorization for placing a biocidal product on the market, issued by the Ministry of Health and valid on the date the tender is submitted. 5. Participants must submit the following for the disinfectants for which they are participating: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use of the products offered. 6. The shelf life of the medical devices must be no shorter than 6 (six) months from the date of the acceptance and handover report for their delivery. 7. The packaging label must be in Bulgarian and contain information about the manufacturer and importer (if the goods are imported), the type of goods, their essential characteristics, shelf life and storage conditions, and instructions for use. The packaging must indicate the batch-release authorization and/or analytical certificate certifying the reliability /quality/ of the medical device – photographic material of the packaging labels shall be submitted with the technical proposal. 8. The participant shall submit catalogs, brochures, information sheets or equivalent materials for the medical devices offered, containing detailed information about them, also translated into Bulgarian, showing all indicators and manufacturing characteristics that indisputably demonstrate the quality of the device offered and its conformity with the technical specifications and equipment. 9. The quantities stated for the individual lots are estimated and must not be interpreted as an obligation on the Contracting Authority regarding a minimum or maximum total quantity (during the contract term) of the stated medical devices. If necessary, the quantities ordered may be exceeded. 10. Other requirements: The disinfection preparations must fully comply with the stated specific requirements. The disinfectants offered by participants must comply with the conditions announced in advance by the Contracting Authority. Compliance with these requirements will be checked as follows: In accordance with the Authorizations for placing biocidal products on the market, using data from the following sections: · Composition – pursuant to item VI – “Data on the active substance of the biocidal product”; · Spectrum of action and method of application: for biocides applied as a ready-to-use solution, pursuant to item VII – “Area of application”; for biocides used as a working solution, pursuant to item VIII – “Method of use”; · The cleaning and disinfecting action of each biocide is determined pursuant to item VIII – “Method of use”; For preparations intended specifically for disinfecting medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including the spectrum of action, is assessed on the basis of the enclosed leaflets /labels/ and the manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

Fast-acting aldehyde-free preparation for cleaning and disinfecting surfaces Must contain 44% ethanol. Must have bactericidal, fungicidal, tuberculocidal and virucidal action against HBV, HIV, HCV, BVDV and Vaccinia virus and be active against enveloped and non-enveloped viruses. Must contain no chlorhexidine, alkylamines or aldehydes. Must be a ready-to-use, fast-acting surface solution with a short exposure time of up to 1 min. Must comply with the following standards: bactericidal and fungicidal action (S. aereus, E. hirae, P. aeruginosa, C. albicans), EN 13697 (including EN 1040, EN 1275, EN 13727 and EN 13624) within 1 min.; Mycobacteria (M. terrae / M. avium), EN 14348, within 1 min.; enveloped viruses (HBV, HIV, HCV, Vaccinia virus, BVDV) and non-enveloped viruses (Rota virus, Adeno virus), EN 14476, within 30 sec.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”.

Requirements for the disinfectants supplied and the participants: 1. The medical devices offered must comply with the requirements of the Medical Devices Act /MDA/ – declared in the participant’s technical proposal; 2. Disinfectants that are medical devices must have a Declaration of Conformity for the medical devices offered/Certificate or equivalent documents of conformity with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body within the meaning of the MDA /or equivalent/ – submitted with the technical proposal where applicable; 3. The medical device must have a Quality Certificate – CE marking, in accordance with the applicable EU directive /or equivalent/ – submitted with the technical proposal where applicable; 4. For disinfectants that are biocides, the participant must submit an authorization for placing a biocidal product on the market, issued by the Ministry of Health and valid on the date the tender is submitted. 5. Participants must submit for the disinfectants for which they are participating: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use of the products offered. 6. The shelf life of the medical devices must be no shorter than 6 (six) months from the date of the acceptance and handover report for their delivery. 7. The packaging label must be in Bulgarian and contain information about the manufacturer and importer (if the goods are imported), the type of goods, their essential characteristics, shelf life and storage conditions, and instructions for use. The packaging must indicate the batch-release authorization and/or analytical certificate certifying the reliability /quality/ of the medical device – photographic material of the packaging labels shall be submitted with the technical proposal. 8. The participant shall submit catalogs, brochures, information sheets or equivalent materials for the medical devices offered, containing detailed information about them, also translated into Bulgarian, showing all indicators and manufacturing characteristics that indisputably demonstrate the quality of the device offered and its conformity with the technical specifications and equipment. 9. The quantities stated for the individual lots are estimated and must not be interpreted as an obligation on the Contracting Authority regarding a minimum or maximum total quantity (during the contract term) of the stated medical devices. If necessary, the quantities ordered may be exceeded. 10. Other requirements: The disinfection preparations must fully comply with the stated specific requirements. The disinfectants offered by participants must comply with the conditions announced in advance by the Contracting Authority. Compliance will be checked in accordance with the Authorizations for placing biocidal products on the market, using data from: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum of action and method of application – for ready-to-use biocides, item VII, “Area of application”; for biocides used as a working solution, item VIII, “Method of use”; · The cleaning and disinfecting action of each biocide is determined pursuant to item VIII, “Method of use”; For preparations intended specifically for disinfecting medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including the spectrum of action, is assessed on the basis of the enclosed leaflets /labels/ and the manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

Preparation for disinfecting perfusors, infusion pumps and medical devices with alcohol-resistant surfaces Must contain 17% propanol and 0.23% didecyldimethylammonium chloride. Combination of alcohol and QAC. For hard-to-reach surfaces and rapid disinfection of equipment within 60 sec. (ready-to-use solution in foam form). Must contain no chlorhexidine, polyhexamethylene biguanide hydrochloride or aldehydes. Must have a broad spectrum of action: bactericidal, fungicidal and virus-neutralizing action (HBV, HIV, HCV, Noro virus, Papova virus, Polio virus, Polyoma virus, Rota virus, Vaccinia virus, Adeno virus; active against encapsulated viruses). Short exposure time of up to 1 min. Must comply with standards: EN 1040, EN 1275, EN 1276; bacteria, yeasts (C. albicans), encapsulated viruses (HBV, HIV, HCV, Vaccinia virus, BVDV), Rotavirus – 1 min. Packaging allowing application by foaming without releasing aerosols.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for the disinfectants supplied and the participants: 1. The medical devices offered must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent documents under the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body within the meaning of the MDA /or equivalent/ – submitted where applicable; 3. The medical device must have a Quality Certificate – CE marking under the applicable EU directive /or equivalent/ – submitted where applicable; 4. For biocides, an authorization for placing the biocidal product on the market, issued by the Ministry of Health and valid on the tender-submission date, must be submitted. 5. Participants must submit: 5.1. A safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from the acceptance and handover report. 7. Packaging labels must be in Bulgarian and state the manufacturer and importer (if imported), type of goods, essential characteristics, shelf life, storage conditions and instructions for use. The packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/ – photographs of labels shall accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent materials with detailed information, also translated into Bulgarian, must show all indicators and manufacturing characteristics indisputably proving quality and conformity with the technical specifications and equipment. 9. Lot quantities are estimated and do not oblige the Contracting Authority to a minimum or maximum total quantity during the contract. Ordered quantities may be exceeded if necessary. 10. Other requirements: Preparations must fully meet the specific requirements and the conditions announced in advance. Compliance shall be checked from market authorizations for biocidal products: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum and application – ready-to-use biocides: item VII, “Area of application”; working solutions: item VIII, “Method of use”; · Cleaning and disinfecting action: item VIII, “Method of use”; For preparations specifically intended for medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including spectrum, is assessed from the enclosed leaflets /labels/, manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

Disinfectant for high-risk areas Powder concentrate based on sodium percarbonate – in situ formation of peracetic acid. With proven bactericidal, fungicidal, tuberculocidal, virucidal and sporicidal action. Short exposure – possibility of full sporicidal action within 15 min. at a maximum concentration of 0.5%.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for the disinfectants supplied and participants: 1. The medical devices offered must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent documents under the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body within the meaning of the MDA /or equivalent/ – submitted where applicable; 3. The medical device must have a Quality Certificate – CE marking under the applicable EU directive /or equivalent/ – submitted where applicable; 4. For biocides, an authorization for placing the biocidal product on the market, issued by the Ministry of Health and valid on the tender-submission date, must be submitted. 5. Participants must submit: 5.1. A safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from the acceptance and handover report. 7. Packaging labels must be in Bulgarian and state the manufacturer and importer (if imported), type of goods, essential characteristics, shelf life, storage conditions and instructions for use. The packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/ – photographs of labels shall accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent materials with detailed information, also translated into Bulgarian, must show all indicators and manufacturing characteristics indisputably proving quality and conformity with the technical specifications and equipment. 9. Lot quantities are estimated and do not oblige the Contracting Authority to a minimum or maximum total quantity during the contract. Ordered quantities may be exceeded if necessary. 10. Other requirements: Preparations must fully meet the specific requirements and the conditions announced in advance. Compliance shall be checked from market authorizations for biocidal products: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum and application – ready-to-use biocides: item VII, “Area of application”; working solutions: item VIII, “Method of use”; · Cleaning and disinfecting action: item VIII, “Method of use”; For preparations specifically intended for medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including spectrum, is assessed from the enclosed leaflets /labels/, manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

Preparation for manual cleaning and disinfection of surgical instruments Non-enzymatic instrument disinfectant; must not contain glyoxal or quaternary ammonium salts. Must contain 20% cocopropylenediamine. Must have bactericidal, tuberculocidal, fungicidal and virucidal action, incl. HBV, HCV, HIV, MRSA, enveloped and non-enveloped viruses. Bactericidal action at a concentration of 0.25% for 15 min.; tuberculocidal action at 0.5% for 30 min. For disinfecting and cleaning surgical instruments, rigid and flexible endoscopes, laboratory and anesthesiology equipment. Must not fix proteins. Suitable for ultrasonic cleaning. Liquid solution, not powder. Its application must not involve additional conditions: temperature, addition of an activator, etc. Intended only for instrument disinfection. Proven working-solution activity for no less than 7 days. Must comply with EN 13727 and EN 13624. Must comply with the efficacy standard for tuberculocidal action (M. Terrae), EN 14348, EN 14563.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

High-level disinfectant (according to Spaulding) for cold chemical sterilization of endoscopic and anesthesiology equipment, aldehyde-based /ready-to-use solution/ Ready-to-use solution based on ortho-phthalaldehyde; with proven bactericidal, fungicidal, tuberculocidal, virucidal and sporicidal action. Main composition – must contain at least 0.5% ortho-phthalaldehyde. Properties of the working solution: Must contain anti-corrosion ingredients. Short exposure of up to 30 min. Working-solution stability of at least 14 days.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

Enzyme-based preparation for manual cleaning Neutral multi-enzyme preparation for highly effective manual cleaning of instruments and thermolabile materials. Preparation based on a combination of 4 enzymes (protease, amylase, lipase and cellulase), suitable for removing biofilm from all types of instruments, endoscopes and thermolabile materials. Suitable for manual cleaning and cleaning in ultrasonic baths, with broad material compatibility. Low working concentration – up to 1% and exposure time up to 10 min.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

DISINFECTANTS FOR SKIN AND OPERATIVE FIELD 1. Ready-to-use preparation for skin and operative field – colored. For disinfecting skin before surgery or other invasive procedures; with rapid effect and long-lasting action. Main composition: alcohol-based, colored with non-toxic degradable dyes for better control of the treated skin surface, and iodine-free. Properties: Must contain no emollients. Must dissolve the skin’s upper lipid layer well. Must be broad-spectrum, with proven bactericidal, fungicidal, tuberculocidal and virucidal (HBV, HIV) action. Must be sterile-filtered. Must be effective with short exposure of up to 2 minutes; hypoallergenic; and contain additional active substances for more prolonged action. 2. Ready-to-use preparation for skin and operative field – colored. Iodine-free disinfectant for the operative field and skin, containing 63% isopropyl alcohol and 2% chlorhexidine, colored solution. With bactericidal, fungicidal and virucidal action. Ready-to-use solution. Must comply with EN 13727, EN 13624, EN 1500. Applicable for disinfecting skin before injections, punctures and blood sampling – exposure time 15 seconds; fast-drying. Long-lasting effectiveness after application. Active against gram (+) and gram (-) bacteria. Active against MRSA. 3. Disinfectant for operative field and skin, iodine-free, alcohol-based, colorless solution – iodine-free, alcohol-based, containing 74.1% ethanol and 10% 2-propanol. Must have bactericidal, fungicidal, tuberculocidal, limited virucidal action (HBV / HIV / HCV, polio). Must be active against MRSA. Ready-to-use solution. For disinfecting skin before operations, injections, punctures and blood sampling – exposure time 15 seconds; disinfecting skin before joint or spinal-canal punctures – exposure time 1 minute; disinfecting skin rich in sebaceous glands – exposure time 10 minutes.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under the applicable EU Dir. / Regulation (EU) 2017/745 of the EP and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum and application – ready solutions: item VII, “Area of application”; working solutions: item VIII, “Method of use”; · Cleaning and disinfecting action: item VIII, “Method of use”; For preparations specifically for medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including spectrum, is assessed from the enclosed leaflets /labels/ and the manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

PREPARATIONS WITH ANTIMICROBIAL ACTION ON SKIN AND MUCOUS MEMBRANES 1. Ready-to-use solution for body decolonization. Active against MRSA. Must have fungicidal action, cellular and tissue tolerance – non-allergenic, non-irritating and without risk of absorption – no development of resistance – usable directly on sensitive or injured skin. No washing required after application – action within 1 minute. 2. Gel for antimicrobial cleaning of the nasal mucosa with betaine and polyhexanide. Must have fungicidal action. Active against MRSA. Good cellular and tissue tolerance – non-allergenic, non-irritating and without risk of absorption – no development of resistance – usable directly on sensitive or injured skin. 3. Foam for antimicrobial whole-body cleaning of immobilized patients. Foam spray with polyhexanide and betaine. Must have fungicidal action. Active against MRSA. Good cellular and tissue tolerance: non-allergenic; non-irritating and without risk of absorption; no development of resistance; usable directly on sensitive or injured skin; no washing required after application; action within 1 minute. 4. Solution for antimicrobial cleaning of wound surfaces. Solution containing 0.1% polyhexanide and 0.1% betaine for antimicrobial cleaning of wound surfaces. 5. Mouthwash for antimicrobial cleaning, containing polyhexanide and betaine. Must have fungicidal action. Active against MRSA. Must contain no chlorhexidine and must leave the oral flora unaffected. No limit on the number of applications. Action within 1 minute. 6. Gel for antimicrobial wound cleaning. Gel for antimicrobial cleaning of wounds, including burns, containing 0.1% polyhexanide and 0.1% betaine.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

Hand disinfectants 1. Hand disinfectant – gel. Gel for hygienic and surgical hand disinfection – based on one alcohol, without hydrogen peroxide or chlorhexidine. Based solely on ethanol – minimum 80%. Fast-acting – up to 30 sec. for hygienic disinfection, up to 90 sec. for surgical disinfection. Must comply with EN 1500 and EN 12791. Full efficacy spectrum – bactericidal (incl. tuberculocidal), fungicidal and fully virucidal (incl. Noro and Rota viruses) action within 30 sec. for hygienic disinfection and within 90 sec. for surgical disinfection. Must contain skin-softening ingredients and be hypoallergenic – fragrance- and dye-free. 1 l package with dosing pump. 2. Hand disinfectant – alcohol-based. Preparation/solution for hygienic and surgical hand disinfection – alcohol-based, without hydrogen peroxide or chlorhexidine. Active substance – ethanol only, minimum 80%. Fast-acting – up to 30 sec. for hygienic disinfection, up to 90 sec. for surgical disinfection. Must comply with EN 1500 and EN 12791. Full efficacy spectrum – bactericidal (incl. tuberculocidal), fungicidal and fully virucidal (incl. Polio, Adeno and Rota viruses) action within 30 sec. for hygienic disinfection and within 90 sec. for surgical disinfection. Must contain skin-softening ingredients and be hypoallergenic – fragrance- and dye-free. 1 l package with dosing pump. 3. Hand disinfectant – chlorhexidine gluconate-based. Preparation based on 4% chlorhexidine digluconate, intended for hygienic and surgical handwashing. Also suitable for pre- and postoperative bathing of the patient. With proven disinfecting effect (bactericidal, fungicidal and virucidal). Must demonstrate efficacy under European standards EN 1499 and EN 12791. 1 l package with dosing pump.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

Preparations for cleaning medical instruments 1. Alkaline preparation for machine cleaning – liquid concentrate. Combined alkaline-enzymatic cleaning preparation for machine cleaning, alkaline pH of 1% solution – up to 10.5. Combination of surfactants and enzymes. Applicable for automated cleaning in washer-disinfectors of surgical instruments, thermostable and thermolabile medical devices, rigid and flexible endoscopes, anesthesiology materials and aluminum containers. Broad material compatibility – incl. stainless steel, aluminum, titanium, copper, brass, chrome, silicones, polyurethanes, Teflon, rubber, latex, plastics and ceramics. Must be approved by washer manufacturers. Must also be usable without a neutralizing preparation after the washing phase in the washer. Dosage up to 10 ml per liter of water. 2. Neutralizing preparation for machine cleaning – liquid concentrate. Liquid concentrate based on inorganic acids. Must be approved by washer manufacturers. Must be compatible with the alkaline preparation specified in the preceding item. 3. Preparation for manual cleaning and neutralization when changing disinfectants with different active substances on instruments and surfaces. For manual cleaning and neutralization of surgical and thermolabile instruments, endoscopes /flexible and rigid/ and surfaces before disinfection or when changing disinfectants with different active substances. Main composition: Neutral preparation based on surfactants and corrosion inhibitors for cleaning all types of instruments, endoscopes, thermolabile materials, etc. Working-solution properties: compatibility with all material types; fast action – up to 15 min.; mild odor and low foaming; also suitable for ultrasonic-bath cleaning. Must be approved by leading global manufacturers of the available endoscopic equipment and instruments /e.g. Pentax, Karl Storz, Olympus and/or Richard Wolf/. 4. Preparation suitable for treating sensitive materials. Multi-enzyme preparation for manual and automated cleaning of instruments and thermolabile materials, based on a combination of 5 enzymes (two proteases, amylase, lipase and cellulase) for cleaning instruments, endoscopes and thermolabile materials. Suitable for manual cleaning and ultrasonic baths. Also suitable for automatic washer-disinfectors. Low working concentration – up to 1% and exposure time up to 10 min.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the EP and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Other requirements: Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum and method of application: ready-to-use biocides pursuant to item VII – continued in additional information (BT-300-Lot) .....

Enzymatic detergents 1. Patented multi-enzyme complex for cleaning heavily contaminated instruments, with a broad spectrum of action against organic residues and biofilms, with 7 enzymes /amylase, lipase, protease, cellulase and 3 others/. Full compatibility with all materials; ready to use; neutral pH; high enzymatic activity and stability; registered medical devices class; restores the original condition of instruments; proven high efficacy on the matrix of biofilms formed by various pathogens; biodegradability ≥ 97% (OECD 302B). Method of use: Dosage: 1%. Contact time: Instruments: 15 min. for manual or ultrasonic cleaning. Endoscopes: 60 minutes (according to the manual-cleaning protocol). Optimal temperature: 40 to 45°C (minimum 30°C and maximum 55°C). 2. Patented and validated technology in dye form for a rapid 5-minute check of the quality of surgical-instrument cleaning. Detection of biofilms and organic residues on medical instruments; rapid results visible on the instrument surface after only 5 minutes; detection sensitivity of 10 μg protein per cm2. Biodegradability ≥ 90%; fragrance-free; the solution must remain stable for up to 2 months after being poured into the bath. 3. Patented multi-enzyme formula for deep cleaning of heavily contaminated items, with specific action on the DNA matrix of biofilms, with 7 enzymes /deoxyribonuclease, protease, lipase, amylase, cellulase + 2 others/. Full compatibility with all materials; ready to use with neutral pH; high enzymatic activity and stability; registered class 1 medical devices; patented for eliminating biofilms; must restore the original condition of instruments, with proven high efficacy on hard organic residues and the biofilm matrix of multiple pathogens; biodegradability ≥ 97%. Method of use: dosage: 0.5%; contact time: Instruments: 5–15 minutes for manual or ultrasonic cleaning. Endoscopes: 1–15 minutes (according to the manual-cleaning protocol). Optimal temperature: 35 to 45°C (minimum 20°C and maximum 55°C).

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Other requirements: Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: · Composition – item VI, “Data on the active substance of the biocidal product”; · Spectrum and method of application: for ready-to-use biocides, item VII – “Area of application”; for biocides used as a working solution, item VIII – “Method of use”; · The cleaning and disinfecting action of each biocide is determined pursuant to item VIII – ............. continued in additional information (BT-300-Lot)

Disinfectant for cold sterilization It must be possible to carry out high-level disinfection of surgical instruments and endoscopic equipment – it must be a ready-to-use solution based on 2% glutaraldehyde. Stability of uncontaminated working preparation: 30 days. Must have proven sporicidal action within 60 min. Contains corrosion inhibitors.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

Specialized medical preparation for breaking down bacterial biofilms The preparation must be capable of attacking the polymer matrix and protective DNA structure of bacteria, making them vulnerable. Neutral pH and compatibility with all materials. High biodegradability (≥ 99%). Concentrate for use at 0.5% to 2%, with short contact time (1 to 15 minutes depending on the instrument).

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – instruments, thermolabile materials, flexible endoscopes – conformity and spectrum are assessed from leaflets /labels/, the manufacturer’s Declaration of Conformity and/or accredited European laboratory reports.

Ready-to-use foam solution for aldehyde-free cleaning and disinfection of equipment Ready-to-use biocidal preparation in foam form, intended for cleaning and disinfecting all hospital surfaces sensitive to the effects of alcohols. Active substance – hydrogen peroxide. Must contain no aldehydes, alcohols or phenols and must not be chlorine-based or based on quaternary ammonium salts. With a full spectrum of action: bactericidal (incl. tuberculocidal and mycobactericidal), fungicidal and fully virucidal (HBV, HCV, HIV, H5N1, Adeno, Noro, Rota, Polio, Polyoma) action achieved with exposure from 1 minute to 30 minutes. Also suitable for rapid intermediate disinfection. With full sporicidal action (Clostr. diff., Bacillus subtilis) within no more than 60 min. In plastic packaging with a foam applicator. No rinsing must be required after treatment. Must meet the criteria for proven effect pursuant to EN 13727, EN 13624, EN 14348, EN 14476, EN 16615, EN 17126.

Wherever the Specification refers to a specific model, source, process, trademark, type, origin or production that could result in favoring or eliminating certain persons or products, it shall be read and understood as “or equivalent”. Requirements for supplied disinfectants and participants: 1. Offered medical devices must comply with the Medical Devices Act /MDA/ – declared in the technical proposal; 2. Medical-device disinfectants must have a Declaration of Conformity/Certificate or equivalent conformity documents under applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical devices, Directive 93/42/EEC, issued by a notified body under the MDA /or equivalent/ – submitted where applicable; 3. The device must have a Quality Certificate – CE marking /or equivalent/ – submitted where applicable; 4. For biocides, a Ministry of Health market authorization valid on the tender date is required. 5. Participants must submit: 5.1. Safety data sheet under Art. 7b of the Protection Against the Harmful Impact of Chemical Substances and Mixtures Act. 5.2. Instructions for use. 6. Shelf life must be at least 6 (six) months from acceptance and handover. 7. Labels must be in Bulgarian and include manufacturer/importer, goods type, essential characteristics, shelf life, storage and use instructions. Packaging must indicate the batch-release authorization and/or analytical certificate certifying reliability /quality/; label photographs accompany the technical proposal. 8. Catalogs, brochures, information sheets or equivalent, with detailed information also translated into Bulgarian, must show all indicators and manufacturing characteristics proving quality and conformity with specifications and equipment. 9. Quantities are estimated, create no minimum/maximum obligation, and may be exceeded. 10. Preparations must fully comply with specific requirements and announced conditions. Verification uses biocidal market authorizations: composition from item VI; spectrum/application from item VII for ready solutions or item VIII for working solutions; cleaning/disinfection action from item VIII. For preparations specifically for medical devices – medical instruments, thermolabile materials and flexible endoscopes – conformity, including the spectrum of action, is assessed on the basis of the enclosed leaflets /labels/ and the manufacturer’s Declaration of Conformity and/or reports from accredited European laboratories.

Procedure: open. Estimated value: 197,352.61 EUR. Review the original TED notice for the complete requirement, lots, amendments and attachments.