ISO 7153-1:2016 PDF

Name: ISO 7153-1:2016 — Surgical instruments — Materials — Part 1: Metals
SKU: ISO 7153-1:2016
Price: 25 EUR
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Surgical instruments — Materials — Part 1: Metals

Название (английский):

ISO 7153-1:2016

Surgical instruments — Materials — Part 1: Metals

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 6 октября 2016 г.
Издание:: ISO IS 7153 edition 3 version 1
ICS:: 11.040.30

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Описание (английский):

ISO 7153-1:2016 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 ISO 7153-1:2016 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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 7153-1:2016 - Surgical instruments - Materials - Part 1: Metals specifies metallic materials commonly used to manufacture standard surgical instruments (for example in general surgery, orthopaedics and dentistry). The standard lists suitable stainless steels, hard metals and titanium grades, gives hardness guidance where applicable, and cross-references related material standards. It is not primarily intended for implantable devices or special applications (e.g., implantology, minimally invasive instruments), although some clauses may be applicable.

Key topics

Fields of application: Tables identify which metal families are appropriate for specific instrument types and components (forceps, scissors, scalpels, handles, springs, screws, etc.).

Stainless steel grades: A comprehensive listing of commonly used stainless steels with associated hardness values (Rockwell and Vickers where available) and their typical application areas.

Hard metals: Designations for wear-resistant inserts and tips (e.g., tungsten carbide with cobalt or nickel binder) including minimum Vickers hardness levels.

Titanium: Reference to implant-quality and standard-quality titanium grades (cross-referenced to ISO 5832‑2/3 and ASTM specifications) for applications requiring low weight and corrosion resistance.

Material selection guidance: Notes that manufacturers must account for instrument design, shape, dimensions and delivery conditions - the standard informs but does not replace manufacturer responsibility.

Cross-references and testing: Normative references include hardness test methods (ISO 6507, ISO 6508), EN and ASTM material standards and correspondence tables to aid international procurement and compliance.

Applications

Selecting appropriate metallic materials during design and procurement of surgical instruments.

Specifying material grades and hardness for manufacturing and quality control.

Choosing wear-resistant inserts and coatings (hard metals) for cutting or high-wear components.

Informing material decisions where weight reduction or biocompatibility (titanium) is desirable.

Harmonizing material specifications across regions by using the standard’s equivalence tables (EN, ASTM, UNS).

Related standards

ISO 5832 series (titanium implant materials)

ISO 6507 / ISO 6508 (Vickers and Rockwell hardness tests)

EN 10088‑1 (stainless steel listings)

ASTM specifications referenced for titanium and surgical steels

Keywords: ISO 7153-1, surgical instruments materials, metals for surgical instruments, stainless steel surgical instruments, titanium surgical instruments, hard metals, medical device standards, material selection, hardness testing.

ISO 7153-1:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics

Applications

Who uses this standard

Related standards

Технические детали

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)

ISO 5832-11:2024

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

SIST EN ISO 7153-1:2017

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