Health Care EEE

The energy use of the equipment shall be measured and reported. The methods and conditions for calculation is specified in the appendix "energy measurement of medical devices". The test report must be submitted at the start of the contact [or at another time specified by the contracting authority].

When delivering the equipment, the supplier must provide information about its environmental performance. Information shall include at least the following:

• How to use the equipment to minimise the environmental impact during installation, use, service, recycling and disposal. Information shall include instructions for minimising consumption of energy, water, consumer goods wear parts and emissions.
• Recommendations for proper maintenance of the equipment, including information on spare parts that can be exchanged and advice on cleaning the equipment.
• Which precautions can be taken to avoid contact with materials containing CMR-classified substances (cancerogenic, mutagenic, reprotoxic substances), endocrine-disrupting substances or substances that may cause sensitisation or an allergic reaction for a patient or user.

The information can be included in a manual, on a web site, or other digital media. Information shall be written in Swedish or English.

The supplier must guarantee the access to compatible spare parts for at least ten (10) years after the equipment delivery.

The supplier must have routines for controlling and managing information on the presence of hazardous substances in the equipment and supplies covered by the contract. The routines shall secure that information regarding presence of hazardous substances in concentrations above 0.1% by weight shall systematically be requested from sub-suppliers. The subjects referred to are substances that are listed in:

• REACH-declaration Candidate List (article 59 in Declaration (EG) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals)
• REACH-declaration appendix XVII (restricted substances list, declaration g (EG) nr 1907/2006)
• RoHS Directive appendix II (2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and electronic equipment).
• The medical device regulation (EU 2017/745), appendix 1, section 10.4.1.

The routines must also secure that the information above is available for the procurer.

The supplier shall, on delivery of equipment and related supplies, declare presence of the substances in the declaration for REACH Candidate List, (article 59 in Declaration (EG) no. 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals).

The report shall include all substances present in a concentration above 0.1% by weight per substance in each individual component.

If during the contract period substances are added that are present in the supplies covered by the agreement, the supplier shall inform the contracting authority accordingly. This must be done within six months after the European Chemicals Agency (Echa) publishes a revised Candidate List.

Points are awarded if the parts of the equipment and medical supplies that are in contact with tissue and body fluids are free from substances classified with the hazard phrases below, as specified in Regulation (EC) No 1272/2008 of the European Parliament on classification, labelling and packaging of substances and mixtures (the CLP Regulation). The concentration shall not exceed 0.1% by weight per substance in each individual part of the product.

Points are awarded if the equipment are free from substances included in REACH- Declaration Candidate List, (article 59 in Declaration (EG) no. 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals) in concentrations above 0.1% by weight per substance in each individual part of the product.

The requirement does not comprise lead and other heavy metals that are part of the radiation protection in x-rays. 

To be awarded [points or price reduction], the supplier shall certify that the equipment can be cleaned with alcohol-based detergents and disinfectants.

Medical equipment and supplies shall not contain the phthalates (1,2-Benzenedicarboxylic esters) in the table below. The total concentration must not exceed 0.1% by weight in each separate part of the offered equipment supplies.

1. The supplier's obligation 

Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding workers’ rights:

• The eight core conventions of ILO regarding forced labour, child labour, discrimination, freedom of association, and the right to collective bargaining (no. 29, 87, 98, 100, 105, 111, 138, and 182).

The terms regarding workers’ rights are called “the Terms” hereafter.

In the event of the core conventions of the ILO are in conflict with national law, the supplier shall take reasonable measures to ensure compliancy with the international regulations.

The obligations concerns workers when they perform work within the frame of the contract.

The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors that directly contribute to the performance of the contract, regardless of the number of intermediaries. In addition, the supplier shall ensure that these subcontractors participate in the follow-up,
according to item 3.

The obligations concerns work carried out under such conditions where Swedish labour law is not applicable.

2. Policies and routines

To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied throughout the entire contract period in their own operation and the operation of any subcontractors who directly contribute to the performance of the contract, regardless of the number of intermediaries.

At the start of the contract the supplier shall have:

2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms,

2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain,

2.3 appointed a manager at the highest management level, responsible for compliance with the Terms,

2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations,

2.5 adopted routines for regular follow-up of the Terms compliance, and

2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations.

The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent.

3. Follow-up

[The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit.

3.1 Self-assessment
Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix.

3.2 Audit
The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit

4. Management of deficiencies

If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority].

In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule.

[The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established
schedule.

[The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms.

1. The supplier’s obligation

Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding human rights, workers’ rights, environmental protection, and anti-corruption (sustainable supply chains):

• the UN Universal Declaration on Human Rights,
• the UN Convention on the Rights of the Child, Article 32,
• the eight core conventions of the ILO regarding forced or compulsory labour, child labour, discrimination, as well as freedom of association and the right to collective bargaining, (no 29, 87, 98, 100, 105, 111, 138, and 182),
• the labour law in force in the country were the work is performed, including regulations for salary, working hours, leisure time, and work environment,
• the environmental law in force in the country were the work is performed, and
• the UN Convention against Corruption.

The terms regarding sustainable supply chains are called “the Terms”  hereafter.

When international regulations prescribe a stronger protection for the individual than the national legislation, the supplier shall take reasonable measures to ensure compliancy with the international regulations.

The obligations concerns all operations connected to the performance of the contract.

The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors in all parts of the supply chain. In addition, the supplier shall ensure that these subcontractors participate in the follow-up, according to item 3.

2. Policies and routines

To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied concurrently throughout the entire contract period in their own operation as well as in the operation of any subcontractors in all parts of the supply chain.

At the start of the contract the supplier shall have:

2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms,

2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain,

2.3 appointed a manager at the highest management level, responsible for compliance with the Terms,

2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations,

2.5 adopted routines for regular follow-up of the Terms compliance, and

2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations.

The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent.

3. Follow-up

[The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit.

3.1 Self-assessment
Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix.

3.2 Audit
The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit.

4. Management of deficiencies

If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority].

In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule.

[The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established
schedule.

[The contracting authority] has the right to terminate the contract with  immediate effect in the case of severe deviations from the Terms.

Points will be awarded for anaesthesia equipment for long and medium term treatment, that are equipped with back pressure compensated low-flow4 function of no more than 2 litres per minute.

Points will be awarded for anaesthesia equipment with features which automatically drive to low flow (automatic low flow function) or provide informational tools which aid the clinician (a guiding user interface) in achieving low flow.

The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.

The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.

The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.

Points will be awarded according to the water usage in litres per treatment,
The treatment cycle shall be as follows, in accordance with IEC 60601-2-16:2018 or equivalent:

• Test - time duration depends on machine
• Filling/Rinsing - 10 Minutes
• Pre-Circulation - 15 Minutes
• Dialysis- 4h

The lower water consumption will be given more points.
The testing shall be performed according to the general requirements in EN ISO 17025, U.S. 21 CFR del 820, ISO 13485 or equivalent.

Points will be awarded for dialysis equipment equipped with an automatic function to reduce the dialysis fluid flow during the time between pre-circulation and dialysis phase. The tenderer shall state the reduced dialysis flow.

Bisphenol A (CAS No. 80-05-7) shall not be added as a constituting element in membranes, filters or tubes. Impurities/residues shall not be present in amounts over 0.01% by weight in each individual part of the product.

Points will be awarded if the equipment contains refrigerants with GWP₁₀₀ (Global Warming Potential) < 10.

The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.

The equipment must have a function that automatically turn on standby mode or shut down after a period of inactivity, or according to a predetermined schedule.