EN ISO 18556:2016 PDF

Name: EN ISO 18556:2016 — Dentistry - Intraoral spatulas (ISO 18556:2016)
SKU: EN ISO 18556:2016
Price: 51.9 EUR
Availability: InStock

Dentistry - Intraoral spatulas (ISO 18556:2016)

Название (английский):

EN ISO 18556:2016

Dentistry - Intraoral spatulas (ISO 18556:2016)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 20 апреля 2016 г.
Издание:: CEN EN 18556 edition 1 version 1
ICS:: 11.060.20

Тип поставки:

Full version180 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:180 €

Описание (английский):

ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items. NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials. It also specifies requirements for their marking and labelling.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 18556:2016 is an international standard developed by CEN and ISO specifying requirements and test methods for intraoral spatulas used in dentistry. These instruments, which can be metallic or non-metallic, are essential tools for introducing and shaping filling materials within tooth cavities. The standard covers both reusable and single-use disposable spatulas, emphasizing quality, safety, and performance. It also regulates the marking and labelling requirements to ensure traceability and compliance.

Key Topics

Scope and Application EN ISO 18556:2016 applies to intraoral spatulas designed for placement, introduction, and modeling of dental filling materials including non-metallic direct restorative substances.

Classification Two main types of spatulas are defined:

Type 1: Oval, cutting, rigid blades
Type 2: Rectangular, flat, flexible blades

Dimensions and Design Standardized dimensions ensure compatibility and usability. For example:

Blade width between 1.4 mm to 3.2 mm
Blade thickness minimum of 0.2 mm
Handle and spatula blade lengths clearly specified for functional use and packaging compatibility

Materials Metallic spatulas must be made from specific corrosion-resistant stainless steels (e.g., X20Cr13, X46Cr13), while non-metallic spatulas use plastic or ceramic materials as appropriate.

Hardness and Durability Blade hardness ranges from 42 to 60 HRC (Rockwell scale) or 410 to 700 HV (Vickers hardness), ensuring resistance to deformation during use.

Surface Quality Surfaces must be smooth and free from defects or residues. Coatings may be applied to enhance lubricity and visibility during dental procedures.

Reprocessing Requirements Metallic spatulas must withstand at least 100 sterilization cycles without corrosion or loss of function, following ISO 17664 protocols. Non-metallic spatulas intended for multiple uses must meet similar durability, except single-use disposables which have manufacturer-defined limits.

Marking and Labelling Instruments must be clearly marked with the manufacturer's name or mark, model/reference number, and batch/lot number for identification and quality control.

Applications

Intraoral spatulas conforming to EN ISO 18556:2016 are vital in a variety of dental procedures, particularly:

Restorative Dentistry Placement and contouring of filling materials such as composites and amalgams into tooth cavities.

Direct Restorative Material Handling Ensuring precise modeling and shaping of plastics or ceramic restorative materials during cavity restoration.

Single-Use Procedures When sterility and cross-contamination control are critical, disposable spatulas meeting this standard provide safe, disposable options.

Reusable Instrument Sterilization Facilitating efficient cleaning, disinfection, and sterilization processes in dental practices while maintaining instrument integrity.

Related Standards

For comprehensive dental instrument quality and safety, EN ISO 18556:2016 is complemented by the following standards:

ISO 1942: Dentistry - Vocabulary Defines dental terminology ensuring consistency across instruments and procedures.

ISO 6507-1 & ISO 6508-1: Metallic materials - Hardness Tests (Vickers and Rockwell) Provide methods to measure hardness of spatula blades to verify compliance.

ISO 17664: Sterilization of Medical Devices Outlines manufacturer requirements for processing instructions ensuring intraoral spatulas can be effectively resterilized without degradation.

ISO 7153-1: Surgical Instruments - Materials - Metals Specifies suitable corrosion-resistant stainless steel materials for surgical and dental instruments.

By adhering to EN ISO 18556:2016, dental instrument manufacturers and healthcare providers ensure that intraoral spatulas meet stringent quality standards for safety, durability, and functionality - essential for effective restorative dental care. This standard supports patient safety and clinical performance through clear requirements for materials, dimensions, hardness, and reprocessing resilience.

EN ISO 18556:2016 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

ISO 18556:2016

Dentistry — Intraoral spatulas

SIST EN ISO 17664-2:2024

Processing of health care products - Information to be provided by the medical device manufacturer for the pr…

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

SIST EN ISO 6507-1:2023

Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023)

SIST EN ISO 6508-1:2024

Metallic materials - Rockwell hardness test - Part 1: Test method (ISO 6508-1:2023)

SIST EN ISO 7153-1:2017

Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)