EN 868-2 2025终端灭菌医疗器械的包装-第2部分灭菌包材要求和测试方法

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EUROPEAN STANDARD

NORMEEUROPÉENNE

EUROPÄISCHENORM

EN 868-2

April 2025

ICS 11.080.30 Supersedes EN 868-2:2017

English Version

Packaging for terminally sterilized medical devices-Part

2:Sterilization wrap-Requirements and test methods

Emballages des dispositifs médicaux stérilisés au stade

terminal-Partie 2:Enveloppe de stérilisation-

Exigences et méthodes d'essai

Verpackungen für in der Endverpackung zu

sterilisierende Medizinprodukte-Teil 2:

Sterilisierverpackung-Anforderungen und

Prüfverfahren

This European Standard was approved by CEN on 14 March 2025.

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 ofAustria,Belgium,Bulgaria,Croatia,Cyprus,Czech Republic,Denmark,Estonia,

Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,

Poland, Portugal, Republic ofNorth Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and

United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉENDE NORMALISATION

EUROPÄISCHESKOMITEE FUR NORMUNG

CEN-CENELEC Management Centre:Rue de la Science 23,B-1040 Brussels

◎2025 CEN All rights ofexploitation in any form and by any means reserved Ref.No.EN 868-2:2025E

worldwide for CEN national Members.

EN 868-2:2025(E)

Contents Page

European foreword............................................................................................................................... 3

Introduction............................................................................................................................................... 5

1 Scope............................................................................................................................................... 6

2 Normative references............................................................................................................... 6

3 Terms and definitions .................................................................................................................7

4 General requirements...............................................................................................................7

5 Performance requirements and test method....................................................................... 8

5.1 General..........................................................................................................................................8

5.2 Specific requirements for wrap made of creped paper......................................................8

5.3 Specific requirements for wrap made of nonwoven materia........................................... 9

5.4 Specific requirements for wrap made of woven textile materia....................................... 9

6 Sterilization compatibility...................................................................................................... 10

7 Labelling ................................................................................................................................... 10

7.1 General....................................................................................................................................... 10

7.2 Sales packaging....................................................................................................................... 10

7.3 Inner packaging....................................................................................................................... 10

8 Information to be provided................................................................................................... 11

8.1 Application of the sterilization wrap................................................................................... 11

8.2 Environmental declaration......................................................................................................11

Annex A(informative) Method for the determination of drape ...................................................12

Annex B(normative) Method for the determination of water repellency ............................... 14

AnnexC(normative) Method for the determination of pore size ............................................... 17

Annex D(informative) Repeatability and reproducibility of test methods............................... 22

AnnexE(informative) Environmental aspect....................................................................................24

Bibliography ........................................................................................................................................... 27

EN 868-2:2025(E)

European foreword

This document (EN 868-2:2025)has been prepared by Technical Committee CEN/TC102“Sterilizers and

associated equipment for processing of medical devices”,the secretariat of which is held by DIN.

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 October 2025,and conflicting national standards shall

be withdrawn at the latest by October 2025.

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

patent rights.CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 868-2:2017.

EN 868-2:2025 includes the following significant technical changes with respect to EN 868-2:2017:

a) The scope has been revised for clarity; plain paper has been removed as material for sterilization

wrap.

b)The document was renumbered to limit the list numbering to 3 levels only for better readability.

c) Clause 4“General requirements”was slightly revised for clarity and aligned with the other parts of

the EN 868 series,and a statement was added clarifying when requirements apply.

d)Clause 5“Performance requirements and test methods”:materials used solely for irradiation

sterilization are excluded from the requirements regarding wet tensile strength of the wrap.

e) Clause 6"Sterilization compatibility"was added and aligned with the other parts of the EN868

series.

f) Subclause 8.2"Environmental declarations"was added and aligned with the other parts of EN 868

series.

g) The list of major changes was moved to the foreword,thus the Annex with"Details of significant

technical changes between this European Standard and the previous edition”(former Annex A)was

deleted.

h)New Clause "Environmental aspects for testing"was added to each test method in Annexes A to C.

i) New Annex E regarding environmental aspects was added.

EN 868 consists of the following parts,under the general title Packaging for terminally sterilized medical

devices:

—Part 2:Sterilization wrap—Requirements and test methods;

—Part3:Paper for use in the manufacture ofpaper bags (specified in EN 868-4)and in the manufacture

of pouches and reels (specified in EN 868-5)—Requirements and test methods;

—Part4:Paper bags—Requirements and test methods;

—Part 5:Sealable pouches and reels ofporous materials and plasticfilm construction— Requirements

and test methods;

—Part 6:Paperfor low temperature sterilization processes— Requirements and test methods;

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标签： #医疗器械 #测试 #器械

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EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMEN868-2April2025ICS11.080.30SupersedesEN868-2:2017EnglishVersionPackagingforterminallysterilizedmedicaldevices-Part2:Sterilizationwrap-RequirementsandtestmethodsEmballagesdesdispositifsmédicauxstérilisésaustadeterminal-Partie2:Enveloppedestérilisation-Ex...

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