BS EN ISO 7153-1:2016
Current
The latest, up-to-date edition.
Surgical instruments. Materials Metals
Hardcopy , PDF
English
11-30-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
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| DevelopmentNote |
Renumbers and supersedes BS 5194-1(1991). (03/2001) Supersedes 97/560505 DC. (03/2005) Supersedes 15/30314608 DC. (11/2016)
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| DocumentType |
Standard
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| Pages |
22
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
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.
| Standards | Relationship |
| I.S. EN ISO 7153-1:2016 | Identical |
| UNE-EN ISO 7153-1:2017 | Identical |
| SN EN ISO 7153-1 : 2016 | Identical |
| DIN EN ISO 7153-1:2015-07 (Draft) | Identical |
| ISO 7153-1:2016 | Identical |
| NBN EN ISO 7153-1 : 2001 | Identical |
| NEN EN ISO 7153-1 : 2016 | Identical |
| NF EN ISO 7153-1 : 2016 | Identical |
| UNI EN ISO 7153-1 : 2001 | Identical |
| NS EN ISO 7153-1 : 2000 | Identical |
| EN ISO 7153-1:2016 | Identical |
| DIN EN ISO 7153-1:2001-02 | Identical |
| 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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