prEN 868-4

SLOVENSKI STANDARD
01-junij-2024
Embalaža za končno sterilizirane medicinske pripomočke - 4. del: Papirnate vrečke
- Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements
and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 4:
Papierbeutel - Anforderungen und Prüfverfahren
Emballage des dispositifs médicaux stérilisés au stade terminal - Partie 4 : Sacs en
papier - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-4
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.080 Vreče. Vrečke Sacks. Bags
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2024
ICS 11.080.30 Will supersede EN 868-4:2017
English Version
Packaging for terminally sterilized medical devices - Part
4: Paper bags - Requirements and test methods
Emballage des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 4 : Sacs en papier - Exigences et sterilisierende Medizinprodukte - Teil 4: Papierbeutel -
méthodes d'essai Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-4:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General requirements . 7
5 Construction and design . 7
5.1 General. 7
5.2 Bottom seal formation . 8
5.3 Back seam construction. 8
5.4 Process indicator . 8
5.5 Seal strip. 8
6 Performance requirements and test methods . 8
7 Sterilization compatibility . 9
8 Labelling . 9
8.1 General. 9
8.2 Paper bags . 9
8.3 Sales packaging . 9
9 Information to be provided . 10
9.1 Information on the sealing or closure conditions . 10
9.2 Environmental declarations . 10
Annex A (normative) Method for the determination of pH value, chloride and sulphate in
paper bags . 11
Annex B (normative) Method for the determination of the tensile strength of the back seam
joint in paper bags . 13
Annex C (informative) Repeatability and reproducibility of test methods . 14
Annex D (informative) Environmental aspects . 15
Bibliography . 18

European foreword
This document (prEN 868-4:2024) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 868-4:2017.
This document includes the following significant technical changes with respect to EN 868-4:2017:
a) Normative reference to EN ISO 187 was added.
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
EN 868 series and a statement was added clarifying when acceptance criteria apply.
d) Clause 7 “Sterilization compatibility” was added, aligned with the other parts of EN 868 series.
e) Clause 9.2 “Environmental declarations” was added and aligned with the other parts of EN 868
series.
f) List of major changes were moved to Foreword, thus Annex A was deleted.
g) New Clause “Environmental aspects for testing” was added to each test method in Annexes A – B.
h) New Annex D 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;
— Part 3: Paper for use in the manufacture of paper bags (specified in EN 868 4) and in the manufacture
of pouches and reels (specified in EN 868 5) — Requirements and test methods;
— Part 4: Paper bags — Requirements and test methods;
— Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements
and test methods;
— Part 6: Paper for low temperature sterilization processes — Requirements and test methods;
— Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test
methods;
— Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements
and test methods;
— Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods;
— Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods.
In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” has prepared the series
EN ISO 11607 “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series specifies
general requirements for materials, sterile barrier systems and packaging systems (Part 1) and validation
requirements for forming, sealing and assembly processes (Part 2).
Introduction
The EN ISO 11607 series of standards consists of two parts under the general title “Packaging for
terminally sterilized medical devices”. Part 1 of this series specifies general requirements and test
methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems
that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2
of this series specifies validation requirements for forming, sealing and assembly processes.
General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1 and
EN ISO 11607-2.
The EN 868 series of standards have been developed mainly for materials and sterile barrier systems
used in health care facilities sterilization processes. The EN 868 series of standards can be used to
demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1.
Considering CEN guide 4 [1] and the CEN environmental checklists, this revision has been complemented
with a new annex with guidance to encourage users to also include environmental aspects when applying
the EN 868 series of standards with the objective to minimize the environmental impact. Environmental
aspects have also been included into the description of test methods with the same objective.
1 Scope
This document specifies test methods and values for single-use paper bags manufactured from paper
specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized
medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of
EN 868 specifies materials, test methods and values that are specific to the products covered by this
document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 868-3, Packaging for terminally sterilized medical devices — Part 3: Paper for use in the manufacture
of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) -
Requirements and test methods
EN ISO 187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure
for monitoring the atmosphere and conditioning of samples (ISO 187)
EN ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of
elongation method (20 mm/min) (ISO 1924-2)
EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General
requirements (ISO 11140-1)
EN ISO 11607-1:2020, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2)
EN ISO 14021, Environmental labels and declarations — Self-declared environmental claims (Type II
environmental labelling) (ISO 14021)
EN ISO 14025, Environmental labels and declarations — Type III environmental declarations — Principles
and procedures (ISO 14025)
ISO 6588-2:2021, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot
extraction
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 9197, Paper, board and pulps — Determination of water-soluble chlorides
ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2020 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
4 General requirements
4.1 For any preformed sterile barrier system or sterile barrier system, the requireme
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