Primary and secondary packaging for disposable gloves
Level: Core
This requirement is set so that primary and secondary packaging shall be designed with appropriate materials for the disposable gloves to maintain the correct degree of purity (level of sterility for sterile gloves) to avoid contamination, and to reduce the environmental impact from the packaging materials. It is important that the primary and secondary packaging are labelled with relevant information and symbols to ensure correct protection and use of the gloves, in accordance with the guidance provided in the stated standards. It is also important that the secondary packaging is available in different sizes, to minimise the risk of wastage, which also applies if there is excess filling in the secondary packaging.
Details
- Type:
- Technical specification
- ID:
- 11218:1
- Group:
- Disposable gloves for medical use
Criterion text
Packaging shall be sized so that no unnecessary packaging material us used and shall meet the requirements in Council Directive 94/62/EC on packaging and packaging waste.
- No packaging material shall contain PVC.
- Sterile medical
- Surgical gloves: The material used for the secondary packaging shall be a triple-layer sterile barrier system, with gloves individually packaged in sterile packaging bags in accordance with ISO 11607-1:2019/Amd 1:2023 (Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems) or the equivalent.
- The secondary packaging shall show information about the glove material, number of gloves contained and glove size, and secondary packaging shall be available in different sizes (from 100 pairs of gloves per secondary packaging). Marking with symbols on the primary and secondary packaging for sterile gloves (a sterile packaging bag for each pair of gloves) in accordance with EN ISO 15223-1 for medical gloves and EN 21420 for laboratory gloves, see the Marking and information that must be provided with medical gloves for single use and Marking of laboratory gloves with personal protection from chemicals attachments.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- A supplier's declaration verifying that the packaging material meets the requirement in accordance with EU Directive 94/62/EC on packaging and packaging waste
- Technical documentation verifying that the material does not contain PVC
- Certificate verifying that the packaging for sterile surgical gloves meets the ISO11607-1 standard or equivalent
- Marking with symbols on the primary and secondary packaging for sterile gloves in accordance with EN ISO 15223–1 for medical gloves and EN 21420 for laboratory gloves.
- The supplier’s self-declaration, including technical documentation of compliance, shall be verified by an accredited verification body that is accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Ensure that the same packaging material is used for the duration of the contract period.
Check that the relevant information is shown on the gloves' packaging, the primary and the secondary packaging for sterile gloves. More information must be included in an enclosed product data sheet.
Check that the seal on the secondary packaging is easily opened and that single-use bags containing the sterile gloves can be taken out without the bag and the sterility being affected in any way. Ensure that the secondary packaging is not overfull and that only the desired number of gloves can be taken out as needed.
Self-declaration verified by an accredited verification body
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
All marking and information shall be easy to locate on the primary and secondary packaging. Information on the packaging and enclosed product data sheet shall be available in Swedish.
Request that a secondary package of gloves is included with the tender so that the glove packaging in the secondary packaging and the marking can be checked. It is important to ensure that the secondary package is not overfull and that it is easy to open its seal in order to maintain the correct level of sanitariness. Bags containing individually packaged sterile gloves shall be easy to remove and open without fibres coming loose from the packaging material.
Depending on the container for the secondary packaging, it may be relevant to have supplementary information included about the size of the gloves. Colour-coding for different sizes can be advantageous.
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
- 11218:1
- Version date
- 2024-03-15
- Review date
- 2022-03-31