DIN EN 868-2:2009
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; English version of DIN EN 868-2:2009-09

Standard No.

DIN EN 868-2:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN 868-2:2017

DIN EN 868-2 E:2015

Latest

DIN EN 868-2:2017-05

Replace

DIN EN 868-2:1999 DIN EN 868-2:2007

Scope

This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 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 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 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. The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse. NOTE 3 If the intended purpose according to the manufacturer of the material for sterile barrier system specifies the use as sterile field, then the additional requirements of the EN 13795 series apply.

DIN EN 868-2:2009 Referenced Document

• EN 20187 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
• EN 20535 Paper and Board - Determination of Water Absorptiveness - Cobb Method (ISO 535 :1991)
• EN 20811 Textiles - Determination of Resistance to Water Penetration - Hydrostatic Pressure Test
• EN 21974 Paper - Determination of Tearing Resistance (Elmendorf Method) (ISO 1974:1990)
• EN 29073-3 Textiles - Test Methods for Nonwovens - Part 3: Determination of Tensile Strength and Elongation
• EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
• EN ISO 13937-1 Textiles - Tear properties of fabrics - Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 13937-1:2000/Cor.1:2004)
• EN ISO 13938-1 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:2019)*， 2019-12-04 Update
• EN ISO 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)*， 2024-04-19 Update
• EN ISO 2758 Paper - Determination of bursting strength*， 2014-08-01 Update
• EN ISO 536 Paper and board - Determination of grammage (ISO 536:2019)*， 2020-02-05 Update
• ISO 3689 Paper and board; Determination of bursting strength after immersion in water (Revision of ISO 3689-1976)
• ISO 3781 Paper and board - Determination of tensile strength after immersion in water*， 2011-09-01 Update
• ISO 5636-3 Paper and board.Determination of air permeance (medium range) .Part 3: Bendtsen method*， 2013-11-01 Update
• ISO 6588-2:2005 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2: Hot extraction
• ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
• ISO 9197 Paper, board and pulps - Determination of water-soluble chlorides*， 2016-08-01 Update
• ISO 9198 Paper, board and pulp — Determination of water-soluble sulfates*， 2020-09-18 Update
• ISO 9237 Textiles - Determination of the permeability of fabrics to air

DIN EN 868-2:2009 history

• 2017 DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
• 2017 DIN EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
• 2009 DIN EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; English version of DIN EN 868-2:2009-09
• 0000 DIN EN 868-2:2007
• 0000 DIN EN 868-2:1999