BS EN ISO 7153-1-2016

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BS EN ISO 7153-1:2016

Surgical instruments —

Materials

Part 1: Metals (ISO 7153-1:2016)

BSI Standards Publication

WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06

BS EN ISO 7153-1:2016 BRITISH STANDARD

National foreword

This British Standard is the UK implementation of EN ISO

7153-1:2016. It supersedes BS EN ISO 7153-1:2001 which is

withdrawn.

The UK participation in its preparation was entrusted to Technical

Committee CH/170, Surgical instruments.

A list of organizations represented on this committee can be

obtained on request to its secretary.

This publication does not purport to include all the necessary

provisions of a contract. Users are responsible for its correct

application.

Published by BSI Standards Limited 2016

ISBN 978 0 580 88328 6

ICS 11.040.30; 77.140.20

Compliance with a British Standard cannot confer immunity from

legal obligations.

This British Standard was published under the authority of the

Standards Policy and Strategy Committee on 30 November 2016.

Amendments/corrigenda issued since publication

Date T e x t a f f e c t e d

EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN ISO 7153-1

October 2016

ICS 11.040.30; 77.140.20 Supersedes EN ISO 7153-1:2000

English Version

Surgical instruments - Materials - Part 1: Metals (ISO

7153-1:2016)

Instruments chirurgicaux - Matériaux - Partie 1:

Métaux (ISO 7153-1:2016)

Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle

(ISO 7153-1:2016)

This European Standard was approved by CEN on 10 September 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

worldwide for CEN national Members.

Ref. No. EN ISO 7153-1:2016 E

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标签： #ISO

摘要：

BS EN ISO 7153-1-2016 是国际标准化组织发布的关于外科手术器械用不锈钢材料的专用标准，该标准详细规定了适用于制造手术器械的多种不锈钢牌号及其化学成分、力学性能和耐腐蚀性要求。作为医疗器械行业的重要技术规范，该标准涵盖了从基础马氏体不锈钢、奥氏体不锈钢到高耐蚀特殊合金的选用指南，确保手术钳、剪刀、骨凿等器械在灭菌、焊接与反复使用条件下的长期性能稳定。标准中明确列出的不锈钢牌号包括 X20Cr13、X30Cr13、X46Cr13 以及 X17CrNi16-2 等，并引用 ISO

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