Bisphenol A in plastic, core
Level: Core
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.
Details
- Type:
- Technical specification
- ID:
- 11248
- Group:
- General criteria
- Swedish:
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.
Verification
Upon the contracting authority's request, it shall be possible to verify these details using technical documentation from the manufacturer or the equivalent.
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
Request technical documentation proving that the requirement has been met.
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 contracting authority can also request a test report or certificate from an accredited body for assessing compliance. The contracting authority may also test the contents of the product, which can be regulated in the contract terms.
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
- 11248
- Version date
- 2019-05-29
- Review date
- 2022-04-07