Phthalate-free endotracheal tubes

Level: Core

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.

Details

Type:: Award criteria
ID:: 11252
Group:: General criteria
Swedish:: Endotrakealtuber fria från ftalater

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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 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
Any of 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

Ämne	CAS-nr
Di-"isononyl" phthalate (DINP)	28553-12-0 och 68515-48-0
Di-"isodecyl" phthalate (DIDP)	26761-40-0 och 68515-49-1
Di-n-octyl phthalate (DNOP)	117-84-0

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].

¹Percent by weight applies to each individual part of a composite item and thus means, not 0.1 percent of a composite product, but 0.1 percent 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 the phthalates (esters of 1,2 benzene dicarboxylic acid) covered by the award criterion and exceeding 0.1 percent by weight for each substance and each individual part of the endotracheal tube.
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.

Information about the criterion

The core criterion 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.

Examples of phthalates included on the candidate list:

Ämne	CAS-nr
Bis(2-ethylhexyl) phthalate (DEHP)	117-81-7
Bis(2-methoxiethyl) phthalate	117-82-8
Dipentyl phthalate (DPP)	131-18-0
Diisopentyl phthalate (DIPP)	605-50-5
1,2-Benzenedicarboxylic acid, di-C7-11- branched and linear alkyl esters	68515-42-4
1,2-Benzenedicarboxylic acid, di-C6-C8-branched alkyl esters, C7-rich	71888-89-6
n-pentyl isopentyl phthalate	776297-69-9
Diisobutyl phthalate (DIBP)	84-69-5
Dibutyl phthalate (DBP)	84-74-2
Dihexyl phthalate	84-75-3
1,2-Benzendicarboxylic acid dipentylester, branched and linear	84777-06-0
Benzyl butyl phthalate (BBP)	85-68-7
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear	68515-50-4
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters	68515-51-5
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters	68648-93-1

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

A Non-Toxic Environment