Consumables made from chlorine-free plastic
Details
- Type:
- Technical specification
- ID:
- 11253
- Group:
- General criteria
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.
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 that the product does not contain chlorinated plastics, in accordance with the requirement.
- 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
Check the technical documentation or analytical protocols to ensure that listed chlorinated plastics are not used in concentrations that exceed those stated in the requirement for supplied products.
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
Endotracheal tubes have been exempted from this requirement because there are no products on the market in chlorine-free plastic that can provide the desired medical function and patient safety. An award criterion can be set to drive the market towards using alternatives to phthalates as plasticisers; Phthalate-free endotracheal tubes (Requirement ID 11252).
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
- 11253
- Version date
- 2019-05-29
- Review date
- 2022-04-07