ISO 11137-2 2015 医疗保健产品灭菌- 辐射- 第 2 部分：确定灭菌剂量

VIP免费

3.0 51zlzl 2025-11-25 16 540.92KB 78 页 80质量币

侵权投诉

EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN ISO 11137-2

June 2015

ICS 11.080.01 Supersedes EN ISO 11137-2:2013

English Version

Sterilization of health care products - Radiation - Part 2:

Establishing the sterilization dose (ISO 11137-2:2013)

Stérilisation des produits de santé - Irradiation - Partie 2:

Établissement de la dose stérilisante (ISO 11137-2:2013)

Sterilisation von Produkten für die Gesundheitsfürsorge -

Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO

11137-2:2013)

This European Standard was approved by CEN on 20 May 2015.

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

ll rights of exploitation in any form and by any means reserved

worldwide for CEN national Members.

Ref. No. EN ISO 11137-2:2015 E

BS EN ISO 11137-2:2015

Foreword

The text of ISO 11137-2:2013 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health

care products” of the International Organization for Standardization (ISO) and has been taken over as EN

ISO 11137-2:2015 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of

which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn

at the latest by December 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11137-2:2013.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directives.

For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this

document.

The following referenced documents are indispensable for the application of this document. For undated

references, the edition of the referenced document (including any amendments) listed below applies. For

dated references, only the edition cited applies. However, for any use of this standard within the meaning of

Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded

and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a

normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the

ISO or IEC standard as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in

whole or in part) to which they apply.

Table — Correlation between normative references and dated EN and ISO standards

Normative references

as listed in Clause 2 of the ISO

standard

Equivalent dated standard

EN ISO

ISO 11137 EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006/A1:2013

ISO 11737-1 EN ISO 11737-1:2006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007

ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following

countries are bound to implement this European Standard: 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 the United Kingdom.

Endorsement notice

The text of ISO 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2015 without any modification.

EN ISO 11137-2:2015 (E)

BS EN ISO 11137-2:2015

Annex ZA

(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 90/385/EEC on active implantable

medical devices

This European Standard has been prepared under a mandate given to CEN/CENELEC by the European

Commission and the European Free Trade Association to provide a means of conforming to Essential

Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the normative clauses of

this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that risks

have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according

to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

1, 4, 5, 8, 9 and 10 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC

Clauses of this European

Standard

Essential Requirements (ERs) of

EU Directive 90/385/EEC

Qualifying remarks/Notes

4, 5, 6, 7, 8, 9, 10 7 Only a sterilization process using

ionizing radiation is considered by

this standard.

This relevant Essential

Requirement is only partly

addressed in this European

Standard. Design and packaging

for maintenance of sterility during

transportation and storage are not

covered. Aspects of manufacture

other than those related to

sterilization are not covered.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.

EN ISO 11137-2:2015 (E)

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载 VIP免费下载

标签： #ISO #医疗保健产品灭菌 #医疗保健产品

摘要：

EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO11137-2June2015ICS11.080.01SupersedesENISO11137-2:2013EnglishVersionSterilizationofhealthcareproducts-Radiation-Part2:Establishingthesterilizationdose(ISO11137-2:2013)Stérilisationdesproduitsdesanté-Irradiation-Partie2:Établissementdeladosestérilisa...

展开>> 收起<<

ISO 11137-2 2015 医疗保健产品灭菌- 辐射- 第 2 部分：确定灭菌剂量.pdf

共78页,预览50页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

ISO 11137-2 2015 医疗保健产品灭菌- 辐射- 第 2 部分：确定灭菌剂量

相关推荐

相关内容

热门标签

举报选择: