Medical Consumables
Consumables used in medical care include a large number of items that are purchased for use in healthcare. Health and the environment are especially impacted by hazardous chemical additives, use of finite resources and generation of waste. These consumables predominantly consist of disposable items, which results in a considerable amount of waste. Extensive material flow has a significant impact on the environment due to the consumption of large volumes of raw materials and energy use during manufacture, and through emissions of hazardous substances during production, transportation, use and waste disposal.
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| Standards for the manufacture and inspection of disposable gloves | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The production of disposable gloves in accordance with harmonised standards ensures compliance with directives and regulations regarding quality and safety. This requirement ensures that the end user is safeguarded from the risk or hazard that the gloves are intended to protect against, and that the disposable gloves offer the correct level of protection and are marked appropriately. Criterion text
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| Pinhole defects (AQL) for disposable gloves | Advanced | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The purpose of this requirement is to allow gloves to be tendered with a higher standard for pinhole defects than the AQL set in standards within relevant areas, where a disposable glove with greater safety is needed. It is important to be able to ensure the quality of a glove's function and that it is safe to use, with the fewest possible defects. Criterion text Tendered products shall meet the following AQL levels:
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| Powder-free disposable gloves | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The following requirements ensure that all disposable gloves are powder-free and that powdered gloves are not tendered. Criterion text All tendered disposable gloves shall be free from powder residues, and the amount of powder found in the gloves shall not exceed 2 mg/glove. The following test methods can be used for determining the amount of powder in all tendered disposable gloves:
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| Substances for skincare in disposable gloves | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information This requirement ensures that gloves shall not be used as skincare products, because substances added to gloves can contribute to causing irritation or contact hypersensitivity to the gloves. Criterion text Substances intended to moisturise or soften the hands shall not be added to or included in the tendered products. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Limitation of biocides (antimicrobial substances) | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Limitation of phthalates (vinyl gloves) | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Different types of chemicals are used for different types of glove. Plasticisers in gloves can increase their environmental impact as well as constituting a health risk, as documented for phthalates as a chemical group, which is based on the substance phthalic acid. Phthalates used as plasticisers in plastic – especially PVC (vinyl) – can be avoided by setting this requirement. Criterion text Phthalates, diesters of orthophthalic acid, in concentrations above 0.1 % by weight (1000 mg/kg) for each substance shall not be included in disposable polyvinyl chloride (PVC) gloves. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accelerator-free disposable gloves (nitrile) | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information Use of disposable gloves and laboratory gloves may lead to skin irritation and/or sensitisation to substances with contact allergenic properties. Thiurams, thiazoles and carbamates are accelerators and known contact allergens. It is therefore important that disposable gloves can be tendered that does not contain accelerators, and that can be used by staff with proven allergies. Criterion text The following groups of chemicals shall not be used in the manufacture of tendered accelerator-free disposable nitrile gloves: Accelerators or components known to form accelerators, such as thiurams, dithiocarbamates and thiazoles (see the Chemicals and allergens in the manufacturing of disposable gloves attachment) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Laboratory gloves with personal protection from chemicals | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information This requirement is set because it is important that gloves are suitable to protect from various hazards in laboratory or healthcare contexts, where greater protection is needed, and when gloves need to be extra resistant to chemicals, such as in connection with various treatments such as those involving cytostatics. Criterion text Laboratory gloves shall meet the requirements set for various protection classifications for chemicals and breakthrough times:
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| Primary and secondary packaging for disposable gloves | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information This requirement is set so that primary and secondary packaging shall be designed with appropriate materials for the disposable gloves to maintain the correct degree of purity (level of sterility for sterile gloves) to avoid contamination, and to reduce the environmental impact from the packaging materials. It is important that the primary and secondary packaging are labelled with relevant information and symbols to ensure correct protection and use of the gloves, in accordance with the guidance provided in the stated standards. It is also important that the secondary packaging is available in different sizes, to minimise the risk of wastage, which also applies if there is excess filling in the secondary packaging. Criterion text Packaging shall be sized so that no unnecessary packaging material us used and shall meet the requirements in Council Directive 94/62/EC on packaging and packaging waste.
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| Sensitizing (allergenic) compounds in disposable gloves | Core | Special contract terms | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The use of disposable gloves can lead to irritation of the skin and/or sensitisation to substances with contact allergenic properties. It is therefore important to know which chemicals have been used in the manufacture of the tendered product and that constituent substances are declared. Criterion text At the start of the contract, the manufacturer shall specify the constituent substances that are either added during manufacture or are already known to be included in the product, such as accelerators or antioxidants that are known to cause health effects based on available data. See the Chemicals and allergens in the manufacturing of disposable gloves attachment | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content of Substances of Very High Concern (Candidate List) | Core | Special contract terms | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information 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. Criterion text For the duration of the contract, the supplier must be able to provide information on substances of very high concern as set out in the Candidate List in Article 59 of Regulation (EC) No 1907/2006 (REACH) at a concentration above 0.1% by weight (1,000 mg/kg) for each substance used in products covered by the contract. 0.1% by weight refers to each individual part of an item. The information must be provided in accordance with Article 33 of Regulation (EC) No 1907/2006 (REACH). Within 45 days of receiving a request from the contracting organisation, the supplier must present details of the existence of substances of very high concern used in the products. In its tender, the supplier must provide a short description of how it keeps information available about substances on the Candidate List that are used in the products, as well as its procedures for ensuring that the information is kept up to date. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Climate impact of the product | Core | Award criteria | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Criterion information The purpose of this requirement is to reward the suppliers who can obtain information about the climate impact of the products from a life-cycle perspective. 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Requirements under the ILO core conventions | Core | Special contract terms | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disposable gloves made from chlorine-free plastic | Core | Technical specification | Disposable gloves for medical use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 disposable gloves for use in healthcare. Criterion text Disposable gloves shall not contain chlorinated plastics in concentrations exceeding 0.1% by weight1 for each individual part of the consumable item. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Procedures for quality management, control, and handling of information on hazardous chemicals | Core | Qualification requirement | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General 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 | General 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 | General 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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | General criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Consumables used in medical care include a large number of items that are purchased for use in healthcare. Health and the environment are especially impacted by hazardous chemical additives, use of finite resources and generation of waste. These consumables predominantly consist of disposable items, which results in a considerable amount of waste. Extensive material flow has a significant impact on the environment due to the consumption of large volumes of raw materials and energy use during manufacture, and through emissions of hazardous substances during production, transportation, use and waste disposal.
One important reason to pay special attention to chemicals in healthcare environments is that those spending time in medical care include groups considered to be extra sensitive, especially new-borns and toddlers. Apart from the fact that these individuals undergo a delicate development, their level of exposure can in some cases be relatively high because children have a high food intake and breathe more in proportion to their size. In healthcare, chemicals can also reach the body via medical equipment, in addition to exposure to xenobiotic substances via food, inhalation of gases and particles or through skin contact. Exposure begins even before a child is born, and some chemicals are also transmitted to nursing babies through the mother's milk.
A properly functioning hormone system is vital for normal development and good health. It is therefore of great importance that consumables purchased for use in healthcare do not contain substances with CMR and PBT properties; that is, Carcinogenic, Mutagenic, toxic to Reproduction, and Persistent, Bio accumulative and Toxic. It is also important that consumables do not contain additives that may risk causing allergic reactions or hypersensitivity in patients and personnel. Serious health effects, such as reproductive disorders, have been reported in connection with several phthalate plasticisers used in plastics. The Swedish Chemicals Agency has received several government assignments involving phthalates and bisphenol A and other bisphenols that cause reproductive disorders and endocrine disruption.
Public procurement is an important policy instrument in the field of healthcare, where public funds account for the largest share of the market. It is of great importance to phase out and replace chemicals that are hazardous to the health or environment to reduce the total exposure for patients and personnel within the healthcare sector, which is also the basis of the A Non-Toxic Environment environmental quality objective. Life-cycle assessments of products and the Precautionary Principle are the basis for requirements in procurement relating to chemicals. Sustainability criteria developed nationally aim to reduce the number of hazardous substances in consumables procured for use by the healthcare services, and to drive the market and supplier towards developing healthy and environmentally adapted products.
The sustainability criteria are produced in dialogue with broad consultation groups in accordance with the authority's mandate to provide relevant support to all parties involved in public procurement. In some areas, it is particularly important to consider health and the environment in public procurement, along with employment and social terms, especially when manufacturing takes place outside the EU.