EN 455-3, “Medical gloves for single use. Requirements and testing for biological evaluation,” has just been updated. The new 2015 Edition is available from Document Center Inc. in a number of national editions. It replaces the previous 2009 Edition, which is now obsolete. EN 455-3 gives methods for protein testing, powder levels, and endotoxin levels. FYI: Extractable latex proteins have an important role in latex allergy.
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labeling and the disclosure of information relevant to the test methods used. It differs from ASTM D5712, “Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method,” in that it addresses medical gloves only. It is one of the harmonized standards for the Medical Device Directive, 93/42/EEC.
What kinds of changes will you see in the new edition? Here’s an outline provided in the draft edition of the update:
- references to the relevant parts of EN ISO 10993 for Biological evaluation of medical devices are added.
- Other “normative” references were revised, including the substitution of EN 15223-1 for EN 980, which is now obsolete.
- Clauses 4.2, 4.4 and 4.6 were updated.
- The term “As low as reasonably practicable” (ALARP) was removed
- The symbol for products containing natural latex was removed.
- Annex B has been updated.
- There’s a new Annex ZA corresponding the standard to the Personal Protective Equipment Directive (89/686/EEC).
Will you need to purchase a copy of the new standard? If you sell single use medical gloves in the EU, you certainly will. There are a number of editions to choose from, and not all are updated yet. Order on the Document Center Inc. webstore at www.document-center.com. Your choices will be BS-EN-455-3, SS-EN-455-3, and DIN-EN-455-3. Since these are the national publications of the source EN document, there is a slight administrative lag as the new editions work themselves through the publication process in each jurisdiction. Questions? Just check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re your Standards Experts!
