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DIN
DIN EN 868-5:2009-09

DIN EN 868-5:2009-09

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Superseded date

02-03-2019

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Anforderungen
  4.1 Allgemeines
  4.2 Materialien
      4.2.1 Poröses Material
      4.2.2 Kunststoff-Verbundfolie
  4.3 Konstruktion und Ausführung
  4.4 Prozessindikator
  4.5 Leistungsanforderungen und Prüfverfahren
  4.6 Kennzeichnung
      4.6.1 Klarsichtbeutel und -schläuche
      4.6.2 Schutzverpackung
5 Vom Hersteller bereitzustellende Angaben
Anhang A (informativ) Angaben über wesentliche
         technische Änderungen zwischen dieser
         Europäischen Norm und der Vorgängerausgabe
Anhang B (normativ) Verfahren zur Bestimmung der
         Beständigkeit gegenüber dem vorgesehenen
         Sterilisationsverfahren
Anhang C (normativ) Verfahren zur Bestimmung von
         feinen Löchern in der Kunststoff-Verbundfolie
Anhang D (normativ) Verfahren zur Bestimmung der
         Festigkeit der Siegelnaht bei Klarsichtbeuteln
         und -schlauchmaterialien
Anhang E (normativ) Verfahren zur Bestimmung der
         Peel-Merkmale von Papier/Kunststoff-Verbundmaterialien
Anhang F (normativ) Verfahren zur Bestimmung der Faserrichtung
Literaturhinweise

This standard is included in DIN Handbook 263 and 265.

DevelopmentNote
Supersedes DIN 58953-4. (09/1999) DRAFT 2017 issued in August 2017. (08/2017)
DocumentType
Standard
Pages
22
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NF EN 868-5 : 2009 Identical
I.S. EN 868-5:2009 Identical
BS EN 868-5:2009 Identical
NEN EN 868-5 : 2009 Identical
SN EN 868-5 : 2009 Identical
NBN EN 868-5 : 2009 Identical
NS EN 868-5 : 2009 Identical
UNE-EN 868-5:2009 Identical
ONORM EN 868-5 : 2009 Identical
UNI EN 868-5 : 2009 Identical
EN 868-5:2009 Identical

DIN HDBK 265 : 2ED 2012 STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE

DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017 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 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 13060:2014 Small steam sterilizers

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PDF - English
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