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BS EN ISO 7153-1:2016

Current
Current

The latest, up-to-date edition.

Surgical instruments. Materials Metals
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2016

This part of ISO7153 specifies metals 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 part of ISO7153 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.

NOTE When 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 part of ISO7153. For this reason, it is not intended, nor is it possible, for the information given in this part of ISO7153 to 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, can 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
W/-
DevelopmentNote
Renumbers and supersedes BS 5194-1(1991). (03/2001) Supersedes 97/560505 DC. (03/2005) Supersedes 15/30314608 DC. (11/2016)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

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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