Heart-lung machine - consumables

Sykehusinnkjøp HF will hold a competition for a Heart-Lung machine - consumables for OUS. The products in the procurement will be organised in accordance with the national category structure: Category: 1003000000 Surgical products Procurement group: 1003030000 Cardiology Tender package: 1003030500 Open heart surgery and perfusion Product group: 1003030508Sett for haemoconsentrator1003030507 …

CPV: 33169000 Instrumentos quirúrgicos, 33182300 Aparatos de cirugía cardíaca, 33184100 Implantes quirúrgicos
Plazo:
17 de junio de 2025 a las 10:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Heart-lung machine - consumables
Organismo adjudicador:
SYKEHUSINNKJØP HF
Número de premio:
2022/13538

1. Buyer

1.1 Buyer

Official name : SYKEHUSINNKJØP HF
Legal type of the buyer : Public undertaking
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Heart-lung machine - consumables
Description : Sykehusinnkjøp HF will hold a competition for a Heart-Lung machine - consumables for OUS. The products in the procurement will be organised in accordance with the national category structure: Category: 1003000000 Surgical products Procurement group: 1003030000 Cardiology Tender package: 1003030500 Open heart surgery and perfusion Product group: 1003030508Sett for haemoconsentrator1003030507 Set to heart lung machine
Procedure identifier : 50a84d0c-afe8-47f2-b317-f60ebbfb2ba8
Internal identifier : 2022/13538
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure : Based on one of our agreement suppliers withdrawing from the Norwegian market, we see ourselves having to start procurement of consumables for a heart, lung machine earlier than planned. Helse Bergen will participate in sub-contracts 4 and 5.The procurement will consist of the following sub-contracts: Sub-contract 01S tube sets for heart-lung machine adults Sub-contract 02 Tube sets for heart-lung-machine children Sub contract 03 Blood cardioplegia set (start 2027) Sub-contract 04 Hemoconcentrator adults Sub-contract 05 Hemoconcentrator children.

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33184100 Surgical implants
Additional classification ( cpv ): 33169000 Surgical instruments
Additional classification ( cpv ): 33182300 Cardiac surgery devices

2.1.2 Place of performance

Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway

2.1.2 Place of performance

Country subdivision (NUTS) : Vestland ( NO0A2 )
Country : Norway

2.1.3 Value

Estimated value excluding VAT : 10 000 000 Norwegian krone

2.1.4 General information

Legal basis :
Directive 2014/24/EU
Anskaffelsesforskriften - Procurement Regulations
Anskaffelsesforskriften - Procurement Regulations

2.1.6 Grounds for exclusion

Sources of grounds for exclusion : Notice
Corruption : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a enforceable verdict has been convicted of corruption by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Corruption as defined in Article 3 of the Convention on Combating Corruption, Involving European Communities or European Union Member States (EUT C 195 of 25.6.1997, s. 1), and in Article 2, point 1, in the Council ́s framework decision 2003/568/RIA of 22 July 2003 on combating corruption in the private sector (EUT L 192 of 31.7.2003, p. 54). This rejection reason also includes corruption as defined in national law for the contracting authority or supplier.
Fraud : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, at the time a legally convicted of fraud has been convicted of fraud by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Fraud included in Article 1 of the Convention on protection of the Financial Interests of the European Communities (EFT C 316 of 27.11.1995, p. 48).
Money laundering or terrorist financing : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of money laundering or financing terrorism by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Money laundering or financing terrorism As defined in Article 1 of the European Parliament and Council Directive 2005/60/EF of 26 October 2005 on preventive measures against the use of the financial system for money laundering and financing terrorism (EUT L 309 of 25.11.2005, p. 15).
Participation in a criminal organisation : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, at the time a legally convicted verdict of participation in a criminal organisation by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Participation in a criminal organisation as defined in Article 2 of the Council ́s framework decision 2008/841/RIA of 24 October 2008 on control of organised crime (EUT L 300 of 11.11.2008, p. 42)
Terrorist offences or offences linked to terrorist activities : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body, or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of acts of terrorism or criminal acts connected to terrorist activities by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Acts of terrorism or criminal acts relating to terrorist activity as defined in Article 1 and 3 of the Council ́s framework decision 2002/475/RIA of 13 June 2002 on combating terrorism (EFT L 164, af 22.6.2002, p. 3). This rejection reason also includes incitement to, participation or attempts to commit such actions as included in Article 4 in the mentioned framework decision.
Child labour and including other forms of trafficking in human beings : Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of child labour and other forms of human trafficking by a verdict handed down no more than five years ago, or a rejection period determined directly in the judgement that still applies? Child labour and other forms of human trafficking as defined in Article 2 of the European Parliament and council directive 2011/36/EU of 5. 1 April 2011 on the prevention and control of human trafficking and the protection of its victims and for compensation of the Council ́s framework decision 2002/629/RIA (EUT L 101 of 15.4.2011, p. 1).
Breaching of obligations in the fields of environmental law : Is the tenderer aware of breaches of environmental provisions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
Breaching of obligations in the fields of labour law : Is the tenderer aware of breaches of provisions on working conditions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
Breaching of obligations in the fields of social law : Is the tenderer aware of breaches of provisions on social conditions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
Agreements with other economic operators aimed at distorting competition : Has the tenderer entered into agreement(s) with other tenderers with the intention of turning the competition?
Grave professional misconduct : Has the tenderer committed serious errors in professional practice? If relevant, see the definitions in national law, the relevant notice or procurement documents.
Misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure : Have the tenderer:a) given grossly incorrect information when notifying the information required to verify that there is no basis for rejection, or of the qualification requirements being met,b) failed to provide such information,c) subject to immediately submitting the supporting documents requested by the Contracting Authority, ord) improperly affecting the Contracting Authority's decision process to acquire confidential information that could give this an unlawful advantage in connection with competition, or negligently has given misleading information that can have a significant influence on decisions on rejection, selection or award?
Conflict of interest due to its participation in the procurement procedure : Are tenderers aware of a conflict of interest as stated in national law, the relevant notice or procurement documents?
Direct or indirect involvement in the preparation of this procurement procedure : Has the tenderer or an entity associated with the supplier advised the contracting authority or in another way been involved in the planning of the competition?
Early termination, damages, or other comparable sanctions : Has the tenderer committed significant breaches of contract in connection with the fulfilment of a previous public contract, a previous contract with a public contracting authority or a previous concession contract, where the breach has led to the cancellation of the contract, compensation or other similar sanctions?
Breaching of obligations set under purely national exclusion grounds : The contracting authority shall state that in Norway there are national rejection reasons. These shall be described in the procurement documents. Tenderers must respond to whether they are in one or more of the situations described in the national rejection reasons. Will the purely national rejection reasons, as stated in the relevant notice or in the procurement documents, apply?
Breaching obligation relating to payment of social security contributions : Have tenderers failed to fulfil all their social security obligations in the country where they are established and in their member state, if this is a different country than what he is established in?
Breaching obligation relating to payment of taxes : Has the tenderer not fulfilled his tax and duty obligations in the country in which he is established, and in the contracting authority's member state, if this is a different country than what he is established in?
Business activities are suspended : Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Bankruptcy : Is the tenderer in a bankruptcy situation? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Arrangement with creditors : Is the supplier in a situation where he has been forced debt arrangement? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Insolvency : Is the tenderer in an insolvency situation? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Assets being administered by liquidator : Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Analogous situation like bankruptcy, insolvency or arrangement with creditors under national law : Is the supplier in a situation where he has been forced debt arrangement? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.

5. Lot

5.1 Lot technical ID : LOT-0000

Title : Heart-lung machine - consumables
Description : Sykehusinnkjøp HF will hold a competition for a Heart-Lung machine - consumables for OUS. The products in the procurement will be organised in accordance with the national category structure: Category: 1003000000 Surgical products Procurement group: 1003030000 Cardiology Tender package: 1003030500 Open heart surgery and perfusion Product group: 1003030508Sett for haemoconsentrator1003030507 Set to heart lung machine
Internal identifier : 2022/13538

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33184100 Surgical implants
Additional classification ( cpv ): 33169000 Surgical instruments
Additional classification ( cpv ): 33182300 Cardiac surgery devices

5.1.2 Place of performance

Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Additional information :

5.1.2 Place of performance

Country subdivision (NUTS) : Vestland ( NO0A2 )
Country : Norway
Additional information :

5.1.3 Estimated duration

Start date : 30/08/2025
Duration end date : 30/08/2029

5.1.5 Value

Estimated value excluding VAT : 10 000 000 Norwegian krone

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Enrolment in a trade register
Description : Tenderers are registered in a company register or a trade register in the member state in which the tenderer is established. As described in annex XI of directive 2014/24/EU; suppliers from certain member states may have to fulfil other requirements in the mentioned annex. Minimum qualification requirements Documentation: Company Registration Certificate is to be submitted via e Proof for Norwegian Tenderer. Foreign tenderers shall present a certificate of statutory registration in the country where the business is established.
Criterion : General yearly turnover
Description : The tenderer ́s ("total") annual turnover for the number of financial years requested in the tender notice or in the procurement documents is as follows: Minimum qualification requirements Documentation: The accounts for the last three years are to be submitted via e Proof for Norwegian tenderers. Foreign Tenderers shall submit their accounts for the last three years with notes, including auditor's report. Minimum requirement: Tenderers shall have profitable operations and positive equity. Tenderers can prove their economic and financial capacity by any other document that the Contracting Authority deems suitable, including, for example, by a parent company guarantee, bank guarantee, etc.
Criterion : References on specified deliveries
Description : Only for public goods deliveries: In the reference period, the tenderer has carried out the following important deliveries of the requested type, or the following important services of the requested type. The contracting authority can require up to three years experience and allow experience from the previous three years to be taken into consideration. Minimum qualification requirements Documentation: List of the most important and relevant deliveries during the past three years, including information about the value and time, as well as the name of the public or private recipients. Minimum requirement: Tenderers shall have previously delivered products to public or private recipients in Norway.
Criterion : Technicians or technical bodies for quality control
Description : Tenderers can use the following technical personnel or technical units , particularly those who are responsible for quality control: For technical personnel or technical units that do not directly belong to the tenderer ́s business, but if the capacity the tenderer will use, cf. part II, section C, separate ESPD forms shall be supplemented. Minimum qualification requirements Documentation: A short description of the Tenderer's personnel and technical units that the Tenderer can use for fulfilment of the contract. Minimum requirement: Tenderers must have access to personnel with good product knowledge for the offered products.

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Norwegian
Deadline for requesting additional information : 03/06/2025 10:00 +00:00
Address of the procurement documents : https://permalink.mercell.com/253682896.aspx

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Norwegian
Electronic catalogue : Required
Variants : Not allowed
Deadline for receipt of tenders : 17/06/2025 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 17/06/2025 10:00 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Required
Electronic ordering will be used : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Maximum number of participants : 100
Information about the dynamic purchasing system :
Dynamic purchasing system, only usable by buyers listed in this notice

5.1.16 Further information, mediation and review

Review organisation : INDRE OG ØSTRE FINNMARK TINGRETT -
Information about review deadlines : In accordance with the Law and Regulations on public procurements.
Organisation providing more information on the review procedures : SYKEHUSINNKJØP HF -

8. Organisations

8.1 ORG-0001

Official name : SYKEHUSINNKJØP HF
Registration number : 916879067
Postal address : Postboks 40
Town : VADSØ
Postcode : 9811
Country subdivision (NUTS) : Finnmark/Finnmárku/Finmarkku ( NO073 )
Country : Norway
Contact point : Postmottak Sykehusinnkjøp
Telephone : +47 78950700
Roles of this organisation :
Buyer
Organisation providing more information on the review procedures

8.1 ORG-0002

Official name : INDRE OG ØSTRE FINNMARK TINGRETT
Registration number : INDRE OG ØSTRE FINNMARK TINGRETT
Postal address : Postboks 54
Town : Vadsø
Postcode : 9811
Country subdivision (NUTS) : Finnmark/Finnmárku/Finmarkku ( NO073 )
Country : Norway
Telephone : 78011700
Roles of this organisation :
Review organisation

10. Change

Version of the previous notice to be changed : 0dc0c7bc-e6b1-40b8-8aa3-8d0491e1f716-01
Main reason for change : Information updated

10.1 Change

Section identifier : ORG-0001

10.1 Change

Section identifier : ORG-0002

10.1 Change

Section identifier : RESULT

10.1 Change

Section identifier : PROCEDURE

10.1 Change

Section identifier : LOT-0000
Notice information
Notice identifier/version : 10848369-ec9b-43d1-a10b-8888e3bd7d78 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 26/05/2025 08:33 +00:00
Notice dispatch date (eSender) : 26/05/2025 08:39 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00339683-2025
OJ S issue number : 101/2025
Publication date : 27/05/2025