EN ISO 10139-2:2016
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)

Standard No.

EN ISO 10139-2:2016

Release Date

2016

Published By

European Committee for Standardization (CEN)

Latest

EN ISO 10139-2:2016

Replace

FprEN ISO 10139-2:2016

Scope

This part of ISO 10139 specifies requirements for softness, adhesion, water absorption and water solubility as well as packaging, labeling and instructions for use for soft denture relining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.

EN ISO 10139-2:2016 Referenced Document

• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 1942:2009 Dentistry - Vocabulary
• ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers
• ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
• ISO 6344-1:1998 Coated abrasives - Grain size analysis - Part 1: Grain size distribution test
• ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ISO 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
• ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times

EN ISO 10139-2:2016 history

• 2016 EN ISO 10139-2:2016 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
• 2009 EN ISO 10139-2:2009 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
• 2001 EN ISO 10139-2:2001 Dentistry - Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use ISO 10139-2: 1999