Latex-free consumables
Level: Core
It is important to reduce the risk of allergies in people who come in contact with consumables used in healthcare. Latex from natural rubber is a sensitising substance that can constitute a serious health risk to patients and personnel if it is included in tendered products.
Details
- Type:
- Technical specification
- ID:
- 11243
- Group:
- General criteria
Criterion text
Consumables shall not contain natural rubber latex.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Technical documentation that the product does not contain natural rubber latex, 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
During any follow-up during the agreement, check the technical documentation, declaration of contents or product data sheet to make sure that natural rubber latex is not used in the delivered 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
If the product contains latex from natural rubber, the manufacturer is obligated to state this, using both symbol labelling and information about the latex content as well as a warning text that latex can cause allergic reactions. Asthma is especially serious, and in severe cases, anaphylaxis (allergic shock) from IgE-mediated latex allergy (type 1) can occur.
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.
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
- 11243
- Version date
- 2019-05-29
- Review date
- 2022-04-07