UNE-EN 868-4:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4: Paper bags - Requirements and test methods
Hardcopy , PDF
Spanish, Castilian, English
02-11-2017
12-11-2025
This draft European Standard provides 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.The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607 1.As such, the particular requirements in 4.2 to 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607 1.The materials specified in this part of EN 868 are intended for single use only.When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN 868-4 : 2017 | Identical |
| NS EN 868-4 : 2017 | Identical |
| I.S. EN 868-4:2017 | Identical |
| NEN EN 868-4 : 2017 | Identical |
| EN 868-4:2017 | Identical |
| NF EN 868-4 : 2017 | Identical |
| NBN EN 868-4 : 2009 | Identical |
| DIN EN 868-4:2015-08 (Draft) | Identical |
| BS EN 868-4:2017 | Identical |
| 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 |
| 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 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 9198:2001 | Paper, board and pulp — Determination of water-soluble sulfates |
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