DIN EN 868-5:2009-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2009
02-03-2019
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Superseded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 |
| NBN EN 868-5 : 2009 | Identical |
| NS EN 868-5 : 2009 | Identical |
| ONORM EN 868-5 : 2009 | Identical |
| EN 868-5:2009 | Identical |
| UNE-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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