PREN 868-4 : DRAFT 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
01-02-2017
18-08-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
changes between this draft European Standard
and the previous edition
Annex B (normative) - Method for the determination of
pH value, chloride and sulfate in paper bags
Annex C (normative) - Method for the determination of
the tensile strength of the back seam joint
in paper bags
Annex D (informative) - Repeatability and Reproducibility
of test methods
Bibliography
Gives test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
| Committee |
TC 102
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 15/30325861 DC : 0 | Identical |
| 07/30166930 DC : DRAFT AUG 2007 | Identical |
| BS EN 867-2:1997 | Non-biological systems for use in sterilizers Process indicators (Class A) |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 6588-2:2012 | Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction |
| EN 868-5:2009 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
| ISO 9197:2016 | Paper, board and pulps Determination of water-soluble chlorides |
| 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 |
| EN ISO 1924-2:2008 | Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008) |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 1924-2:2008 | Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 9198:2001 | Paper, board and pulp Determination of water-soluble sulfates |
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