SIST EN ISO 10139-2:2016 PDF
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 20
- Дата публикации:
- 8 сентября 2016 г.
- ICS:
- 11.060.10
- Технический комитет:
- VAZ - Healthcare
ISO 10139-2:2016 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.
Abstract
Overview
EN ISO 10139-2:2016 - "Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use" is the CEN-adopted version of ISO 10139-2:2016. It defines performance, testing and labelling requirements for soft denture lining materials intended for long-term use (>30 days). These materials can also be used in maxillofacial prostheses. The standard helps manufacturers, laboratories and clinicians ensure material safety, durability and predictable clinical behaviour.
Key topics and technical requirements
- Scope & classification
- Covers materials for long-term use (defined as use > 30 days).
- Classifies materials by softness into Type A (soft) and Type B (extra soft) based on Shore A hardness.
- Shore A hardness
- Mandatory hardness testing at 24 h and 30 d using the Shore durometer method (reference ISO 7619‑1).
- Classification thresholds: Type A: 25
Технические детали
- SKU
- SIST EN ISO 10139-2:2016
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