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UNE-EN ISO 7153-1:2017

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

26-04-2017

€82.80
Excluding VAT

This document specifies metallic materials commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry. While this document is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.NOTEWhen selecting the grade of steel and the shape, dimensions and delivery conditions of the raw material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design of the instrument or the production facilities of the manufacturer, that are not covered by this standard. For this reason, it is not intended, nor is it possible, that the information given in this standard should remove the decision-making responsibility from the instrument manufacturer for selecting an appropriate raw product with suitable properties; nor is it intended to preclude the use of other types of steel in the manufacture of instruments, such as the use of carbon steel for cutting instruments. International Standards for surgical instruments, when published, should be observed when making this decision as they may contain additional or new information to be taken into account when selecting appropriate steel grades.

Committee
CTN 106
DocumentType
Standard
Pages
21
PublisherName
Asociación Española de Normalización
Status
Current

ISO 6507-1:2005 Metallic materials — Vickers hardness test — Part 1: Test method
ASTM B 348 : 2013 : REDLINE Standard Specification for Titanium and Titanium Alloy Bars and Billets
ASTM B 265 : 2015 : REDLINE Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
ISO 6508-1:2016 Metallic materials — Rockwell hardness test — Part 1: Test method
ISO 5832-3:2016 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 5832-2:1999 Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
ISO 13402:1995 Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2017 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
EN 573-3:2013 Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products
ISO 18265:2013 Metallic materials — Conversion of hardness values
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels

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€82.80
Excluding VAT