Phthalate-free products
Level: Core
Hazardous phthalates are used as active additives and softeners in plastics. This group of softeners can be avoided if this requirement is used, and thus reducing the exposure for patients and staff.
Details
- Type:
- Technical specification
- ID:
- 11356
- Group:
- General criteria
- Swedish:
Criterion text
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.
| Substance | CAS-number | |
| 1 | Di(2-ethylhexyl) phthalate | 117-81-7 |
| 2 | Bis(2-methoxyethyl) phthalate; Di(2-methoxyethyl) phthalate (BMEP; DMEP) | 117-82-8 |
| 3 | Dipentyl phthalate (DPP) | 131-18-0 |
| 4 | Diisopentyl phthalate (DIPP) | 605-50-5 |
| 5 | 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (DHNUP) | 68515-42-4 |
| 6 | Di-C6-8-branched alkyl phthalates (DIHP) | 71888-89-6 |
| 7 | N-pentyl-isopentyl phthalate | 776297-69-9 |
| 8 | Diisobutyl phthalate (DIBP) | 84-69-5 |
| 9 | Dibutyl phthalate (DBP) | 84-74-2 |
| 10 | Dihexyl phthalate (DnHP) | 84-75-3 |
| 11 | 1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear | 84777-06-0 |
| 12 | Benzyl butyl phthalate (BBP) | 85-68-7 |
| 13 | 1,2-Benzenedicarboxylic 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, di-C6-10-alkyl esters or mixed decyl and hexyl and octyl diesters | 68648-93-1 |
| 16 | Di-isononyl phthalate (DINP) | 28553-12-0 and 68515-48-0 |
| 17 | Di-isodecyl phthalate (DIDP) | 26761-40-0 and 68515-49-1 |
| 18 | Di-n-octyl phthalate (DNOP) | 117-84-0 |
Verification
Supplier certificate that proves that the equipment and medical supplies do not contain phthalates in concentration higher than that stated in the requirement. The certificate must be signed by the authorized representative of the supplier.
Upon request from the contracting authority, supporting technical documentation shall be shown. The contracting authority may also request random testing to be performed by an independent laboratory or other testing institute.
Proposed follow-up
Check technical documentation (random sample) demonstrating that the concentration of phthalates does not exceed the stated concentration in the requirement.
Information about the criterion
In medical devices phthalates can be present in machine-bound consumption materials, such as tubes and clamps. Phthalates can also be present in mattresses with plastic coating/surfaces. Such mattresses are supplied with certain types of equipment.
Environmental goals
Motive
Phthalates are a group of substances commonly used as plastic softeners (primarily in polyvinyl chloride plastics, PVC) and can constitute 20-40% of the material in medical EEE products. Phthalates can leak from materials, be absorbed by the human body and be found in blood, breast milk, and urine1. Several phthalates are classified as reprotoxic and can affect testicular development, making it difficult to have children. Some phthalates are endocrine-disruptive or suspected to be endocrine-disruptive. The phthalates in the table above are included in the REACH Candidate List, Authorisation List, (Annex XIV), or limitation list, (Annex XVII) (as of January 2019)
Since 2010 all medical devices containing phthalates, classified as CMR-substances (cancerogenic, mutagenic, reprotoxic substances), must be labelled with information about this.
Under the regulation for medical devices that takes effect in May 2020 (EU 2017/245), the use of phthalates, classified as CMR is strictly limited. The use of substitutes to CMR-substances is encouraged. Continued use exceeding 0.1% by weight will require extensive motives from manufacturers of medical equipment.
From July 22, 2019, four phthalates will be prohibited in medical devices; BBP, DEHP, DBP, and Diisobutyl phthalate. These substances are prohibited according to the Ordinance (SFS 2012:861) on hazardous substances in electrical and electronic equipment.
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
- 11356
- Version date
- 2019-06-03