Phthalate-free endotracheal tubes
Level: Core
Endotracheal tubes as a product group are exempt from requirements that the product shall be free from phthalate plasticisers. This requirement may drive the market towards not using additives for which there are known concerns during the manufacture and use of tendered products.
Details
- Type:
- Award criteria
- ID:
- 11252
- Group:
- General criteria
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 phthalates (esters of 1,2 benzene dicarboxylic acid) included in the REACH Candidate. List that applies on the closing date for submission of tenders in concentrations exceeding 0.1% by weight for each substance) and for each part of the endotracheal tubes. The table below is an example of phthalates included on the list as of May 2019. The specified CAS number takes precedence over the name of the substance. 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].
|
Substance |
CAS-number | |
|
1 |
Di(2-ethylhexyl)phtalate (DEHP) |
117-81-7 |
|
2 |
Bis(2-methoxyethyl)phtalate; Di(2-methoxyethyl)talat (BMEP; DMEP) |
117-82-8 |
|
3 |
Dipentyl phtalate (DPP) |
131-18-0 |
|
4 |
Diisopentyl phtalate (DIPP) |
605-50-5 |
|
5 |
1,2-benzenedicarboxylic acid di-(C7-11)- alkyl esters, branched and linear (DHNUP) |
68515-42-4 |
|
6 |
Di(branched C6-C8) alkyl phtalates (DIHP) |
71888-89-6 |
|
7 |
N-pentyl isopentyl phtalate |
776297-69-9 |
|
8 |
Diisobutyl phtalate (DIBP) |
84-69-5 |
|
9 |
Dibutyl phtalate (DBP) |
84-74-2 |
|
10 |
Dihexyl phtalate (DnHP) |
84-75-3 |
|
11 |
1,2-benzenedicarboxylic acid, dipentyl ester, branched and linear |
84777-06-0 |
|
12 |
Benzyl butyl phtalate (BBP) |
85-68-7 |
|
13 |
1,2-benzendicarboxylic acid, dihexyl ester, branched and linear |
68515-50-4 |
|
14 |
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters |
68515-51-5 |
|
15 |
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters |
68648-93-1 |
|
16 |
Diisononyl phtalate (DINP) |
28553-12-0 och 68515-48-0 |
|
17 |
Diisodecyl phtalate (DIDP) |
26761-40-0 och 68515-49-1 |
|
18 |
Di-n-octyl phtalate (DNOP) |
117-84-0 |
1 % by weight applies to each individual part of a composite item and thus means, not 0.1% of a composite product, but 0.1% of each constituent part.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Technical documentation proving that endotracheal tubes in the tender do not contain phthalates (esters of 1,2 benzene dicarboxylic acid) exceeding 0.1% by weight for each substance and each individual part of the consumable item in accordance with the current REACH Candidate List (in connection with the evaluation of tenders).
- The supplier’s self-declaration including technical documentation of compliance verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
The contract terms should explain how the accepted supplier has met the award criteria and should contain a clause stating that the criteria shall be met for the duration of the contract period, along with a description of how and when the supplier shall confirm this.
The supplier shall be able to provide information about phthalates included in the tendered product, as well as any residues that can be found in the final product. The contracting authority may, for example, request that the supplier submit, within [six (6) weeks or other later time determined by the contracting authority] of receipt of the request, technical documentation that proves that the tendered product does not contain phthalates, in accordance with the requirement.
If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.
Subject matter of contract
Criteria for the sustainable procurement of medical consumables are under continuous development within selected product areas. The areas are chosen on the basis ofbased on the volumes used within regions and municipalities and/or their significantce environmental- and health of aspects. relating to health and the environment.
Information about the criterion
The base requirement for phthalate-free consumables(Requirement ID 11249) and this award criterion can be used together. Increasing numbers of regions and county councils in Sweden are following environmental objectives and action plans for replacing phthalates with other plasticisers.
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Environmental goals
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11252
- Version date
- 2019-05-29
- Review date
- 2022-04-07