General criteria
Intermittent catheters, infusion sets, and endotracheal tubes are consumables used in large volumes in urology, anaesthesia, and intensive care. These are disposable items used in direct contact with the blood or body tissues, or for infusion of medicines, parenteral nutrition, blood, and blood products. Patients are exposed to the materials that consumables are made from when they are treated for long intervals of time or during daily use, which can be the case with intermittent catheters. This places extra demands on patient safety and that chemical substances in the consumables should not be hazardous to the health, which is particularly important when treating children and in neonatal care. Another important aspect is assessing the risk of adsorption to or interaction with used plastics and constituent substances during intravenous infusion of medicines, blood and blood products during long infusion times, which has been described.
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| Procedures for quality management, control, and handling of information on hazardous chemicals | Core | Qualification requirement | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Having documented procedures and instructions for quality assurance of products and supply allow for the handling of information and establishing traceability along the supply chain in accordance with existing statutory requirements etcetera for the manufacture of medical consumables. This allows supplies to better be able to meet the requirements regarding technical specifications and to be able to fulfil the contract. Criterion text Together with its tender, the supplier shall submit a description of its procedures for systematic quality management (quality assurance) and the procedures that are used for checking and managing information relating to substances hazardous to the health or environment in the consumables covered by the contract. The description of procedures shall include at least the following points:
Procedures shall be documented and apply for the duration of the contract period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Metal content in plastic | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The aim of this requirement is to ensure that consumables do not contain certain heavy metals. Criterion text Consumables shall not contain lead, cadmium, mercury, hexavalent chromium, or compounds thereof, or organic tin compounds in concentrations exceeding 0.1% by weight of the plastic material. 0.1% by weight applies to each individual part of a product. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Limitation of biocides (antimicrobial substances) | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Products that are treated with biocides (antimicrobial function) contain substances that can be hazardous or toxic to humans and the environment and can accelerate the development of resistance in bacteria. Criterion text Disposable products shall not be treated with biocides – that is, treated with or deliberately containing one or more biocidal products1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Bisphenol A in plastic, core | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Bisphenol A is classified as a substance toxic for reproduction; that is, a substance suspected of being able to harm the fertility or an unborn child in low concentrations. Since 2017, bisphenol A has been included in the REACH Candidate List, and as a CMR substance in the regulation on medical devices. Criterion text Consumables intended for use in direct contact with blood or body tissues shall not contain bisphenol A (CAS no 80-05-7) in concentrations exceeding 0.001% by weight (10 ppm, 10 mg/kg) for each individual plastic part. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Bisphenols in plastic, advanced | Advanced | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information This requirement is set to ensure that bisphenols that have a similar structure and are suspected of having similarly serious characteristics as bisphenol A are not present in the products. Criterion text Consumables containing plastic shall not contain bisphenol A or bisphenols with a similar chemical structure to bisphenol A in concentrations exceeding 0.1% by weight for each separate plastic part of the product. The table shows bisphenols identified in a study by the Swedish Chemicals Agency in 20171. The specified CAS number takes precedence over the name of the substance.
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| Latex-free consumables | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information It is important to reduce the risk of allergies in people who come in contact with consumables used in healthcare. Latex from natural rubber is a sensitising substance that can constitute a serious health risk to patients and personnel if it is included in tendered products. Criterion text Consumables shall not contain natural rubber latex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Phthalate-free consumables | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Phthalates that are hazardous to the health are used as active additives and plasticisers in some plastics. This group of plasticisers can be avoided by using this requirement, thereby reducing the risk of exposure for patients and personnel. Criterion text Consumables shall not contain phthalates included on the current candidate list (Article 59 of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)) in levels above 0.1 weight percent (1000 mg/kg) per substance. 0.1 weight percent refers to each individual part of a product.1 Consumables shall not contain the phthalates listed in the table below in levels above 0.1 weight percent (1000 mg/kg) per substance. 0.1 weight percent refers to each individual part of a product.1
Exception Endotracheal tubes.
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| Consumables made from chlorine-free plastic | Core | Technical specification | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The purpose of this requirement is to avoid plastics containing substances hazardous to the health and environment. By using this requirement, chlorinated plastic such as polyvinyl chloride is avoided for use in tendered consumables for use in healthcare. Criterion text Consumables (except for endotracheal tubes) shall not contain chlorinated plastics in concentrations exceeding 0.1% by weight1 for each individual part of the consumable item. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Phthalate-free endotracheal tubes | Core | Award criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Endotracheal tubes as a product group are exempt from the mandatory requirement that consumables shall be free from phthalates as plasticisers. This award criterion may drive the market towards not using additives for which there are known concerns during the manufacture and use of tendered products. Criterion text To be awarded [points or price deduction] in the evaluation of the bid, the supplier shall confirm in the bid that the endotracheal tubes included in the tender do not contain
Evaluation is carried out according to the REACH Candidate List that applied on the closing date for submission of tenders and according to the contracting authority's evaluation model [points or price reduction]. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Halogen-free plastic consumables | Advanced | Award criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The purpose of this requirement is to avoid plastics containing substances hazardous to the health or environment. By using this requirement, halogenated plastics are avoided for use in tendered consumables, and other halogens are not used as replacements for, for example, chlorine. Criterion text Consumables included in the tender do not contain halogenated plastics in concentrations exceeding 0.1% by weight1 per substance (fluorine, chlorine, bromine, and iodine) and per individual part of the consumable item. Evaluation is carried out in accordance with the contracting authority's evaluation model [points or price reduction]. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Information about the climate impact of consumables | Core | Award criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The purpose of this award criterion is to obtain information about the life-cycle climate impact of the consumable item; the supplier compiles this information in accordance with accepted methods and international standards for life-cycle analyses. Criterion text To be awarded [points/price deductions] in the tender evaluation the supplier shall be able to show the life-cycle climate impact for one or several disposable textiles, under the contract. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content of Substances of Very High Concern (Candidate List) | Core | Special contract terms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Core: Through this requirement, the contracting authority receives information on the content of chemicals hazardous to health or environment listed on the Candidate List in the EU chemicals legislation Reach. Advanced: Through this requirement, content of chemicals hazardous to health or environment listed in the Candidate List in the EU chemicals legislation Reach are minimised. Criterion text During the entire contract period, the supplier shall be able to provide information on whether the consumables delivered in accordance with the contract contain substances included on the current Candidate List (Article 59 of Regulation (EC) No 1907/2006 (Reach)) in concentrations exceeding 0.1 percent by weight (1000 mg/kg). 0.1 percent by weight applies to each individual part of a product1. If new substances are entered on the Candidate List during the contract period, the supplier shall inform the contracting authority if these substances are present in the products covered by the contract. In its tender, the supplier shall provide a brief description on how the supplier keeps information regarding substances on the candidate list that are present in the products available, as well as which routines ensure that this information is kept up-to-date. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content of Substances of Very High Concern (Candidate List) | Advanced | Special contract terms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Core: Through this requirement, the contracting authority receives information on the content of chemicals hazardous to health or environment listed on the Candidate List in the EU chemicals legislation Reach. Advanced: Through this requirement, content of chemicals hazardous to health or environment listed in the Candidate List in the EU chemicals legislation Reach are minimised. Criterion text At [the start of the contract or at another time specified by the contracting authority], consumables delivered under the contract shall not contain substances included in the current Candidate List (Article 59 of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)) in concentrations exceeding 0.1 percent by weight (1000 mg/kg). 0.1 percent by weight applies to each individual part of a product1. If new substances are entered on the Candidate List during the contract period, the supplier shall no later than six months after the European Chemicals Agency (ECHA) has published a revised Candidate List present a time-bound action plan on how the substances can be phased out. In its tender, the supplier shall provide a brief description on how they intend to fulfil the contract term during the contract period | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Requirements under the ILO core conventions | Core | Special contract terms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The contract terms on the basic level aim to ensure that the supplier has effective risk management regarding workers' rights under the ILO core conventions in its own operation as well as in the supply chain regarding subcontractors who are directly involved in the performance of the contract. Criterion text 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 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, 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 3.2 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 [The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sustainable supply chains | Advanced | Special contract terms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The terms regarding sustainable supply chains aim to ensure that the supplier has efficient risk management in their own operation and in the supply chain, covering the areas human rights, labour rights, environmental protection and anti-corruption. Criterion text 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 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 3.2 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 [The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intermittent catheters, infusion sets, and endotracheal tubes are consumables used in large volumes in urology, anaesthesia, and intensive care. These are disposable items used in direct contact with the blood or body tissues, or for infusion of medicines, parenteral nutrition, blood, and blood products. Patients are exposed to the materials that consumables are made from when they are treated for long intervals of time or during daily use, which can be the case with intermittent catheters. This places extra demands on patient safety and that chemical substances in the consumables should not be hazardous to the health, which is particularly important when treating children and in neonatal care. Another important aspect is assessing the risk of adsorption to or interaction with used plastics and constituent substances during intravenous infusion of medicines, blood and blood products during long infusion times, which has been described.
Research has shown that many hormone-related illnesses are on the rise in humans. The potential of endocrine disruption has been demonstrated for many chemicals. Pregnant women, children and adolescents are often highlighted as groups that are particularly sensitive to the effects of endocrine disruption. The use of these chemicals has therefore been questioned from several quarters, and the EU has issued several regulations regarding chemicals that are endocrine disruptors, such as bisphenol A and phthalates. These criteria support contracting authorities that desire to ensure that they have environmentally adapted and healthy consumables in their procured range. The aim of the criteria is to limit the presence of substances hazardous to the health or environment, including additives in plastic material such as phthalates, bisphenol A, other bisphenols, heavy metals, antibacterial substances (biocides), as well as constituent plastics where relevant. It is also important that consumables do not contain substances that can cause serious allergies, such as latex.
The supplier shall be able to provide information about substances that are listed in the REACH Candidate List; that is, substances with properties that can cause serious and lasting negative effects on human health and the environment, which is a legal requirement. The advanced level requires minimising the content of these substances in consumables.
Requirements relating to chemicals in packaging help to reduce the environmental impact of packaging materials, and it is also important to minimise the volume of packaging and that it can be recycled or reused. Reduced wastage of consumables is another important environmental aspect, as is the availability of appropriate packaging sizes for small purchase volumes, such as in childcare and neonatal care. Requirements regarding information about the climate impact of consumables encourages more information to be made available about the products' lifecycle, which is important to allow a comparison of different plastic materials, along with their constituent additives.
Requirements can also be set regarding social and employment terms and can be found in the general criteria: Requirements under the ILO core conventions (Requirement ID 11238) and Sustainable supply chains (Requirement ID 11239).
The general sustainability criteria can be used for the following products and any appropriate accessories:
- Intermittent catheters
- Infusion sets with associated plastic infusion tubing
- Endotracheal tubes and plastic accessories