Laboratory gloves with personal protection from chemicals
Level: Core
This requirement is set because it is important that gloves are suitable to protect from various hazards in laboratory or healthcare contexts, where greater protection is needed, and when gloves need to be extra resistant to chemicals, such as in connection with various treatments such as those involving cytostatics.
Details
- Type:
- Technical specification
- ID:
- 11091:1
- Group:
- Disposable gloves for medical use
Criterion text
Laboratory gloves shall meet the requirements set for various protection classifications for chemicals and breakthrough times:
- The EN 16523-1:2015+A1 2018 Determination of material resistance to permeation by chemicals — Part 1: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact or equivalent. Breakthrough times for relevant substance classes and a selection of relevant substances for which the glove has been tested are shown in Annex A to the SS-EN 374-1 standard and for six different protection classes (in minutes). See the Marking of laboratory gloves with personal protection from chemicals supplement for further information.
- Cytostatic substances only: The ASTM D 6978-05 standard, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs or the equivalent.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- CE marking linked to the product name or item number of the tendered gloves, verifying that the gloves meet the EN 374 and EC certificate standards, in order to verify that the laboratory gloves have been marked with the correct hazard symbols and pictograms; see the Marking of laboratory gloves with personal protection from chemicals supplement. The certificate shall also state the name of the company that owns the trademark.
- 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 EC certificate is valid for the duration of the contract. The EC certificate shall have been issued in the name of the legal manufacturer and shall refer to the gloves that are tendered, either by name or item number and product with a higher risk profile that requires accredited independent examination. Ensure via an independent third party that the certificate has been issued correctly; unfortunately, fake certificates have been circulating in Europe.
Ensure that EC certificates issued according to the requirements set in EN 374-1:2016 are valid and that permeation tests have been conducted in accordance with EN16523-1
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.
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Information about the criterion
Laboratory gloves are primarily used for personal protection, and a CE mark is required for these gloves, along with hazard symbols and pictograms that show the protective function of the gloves for the specified risk. See the Marking of laboratory gloves with personal protection from chemicals supplement.
The supplement to the requirement contains a description and examples of how requirements for gloves that offer personal protection can be set, and when possible, can be combined with other requirements set for medical gloves.
In connection with the procurement, it may be a good idea to state in the tender documents which chemicals all examination gloves shall be able to withstand at a minimum, and to state which chemicals or cytostatic agents are used within each medical facility and that fall under various classes of protection and need to be tested in accordance with EN 374-1 in order to provide the desired personal protection, in accordance with Annex A to the EN 374-1 standard.
It is important that the tenderer provides information on how the tests are conducted for the tendered gloves, so that different gloves can be compared. With regards to allergies, it is important to keep in mind that an alternative type of glove must also be suitable for working with various chemicals. Vinyl gloves are not recommended in contact with chemicals, disinfectants or cleaning agents, since they do not resist chemicals, offering no protection at all, and these substances can negatively affect the function of the gloves.
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
- 11091:1
- Version date
- 2018-06-05
- Review date
- 2022-03-31
2018-06-05, Krav ID 11091: Original version