DIN EN 868-2:2017-05
Current
The latest, up-to-date edition.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2017
National foreword
National Annex NA (informative) - Bibliography
European 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 European
Standard and the previous edition
Annex B (informative) - Method for the
determination of drape
Annex C (normative) - Method for the determination
of water repellency
Annex D (normative) - Method for the determination
of pore size
Annex E (informative) - Repeatability and
reproducibility of test methods
Bibliography
Defines 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.
DocumentType |
Standard
|
Pages |
27
|
PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
Status |
Current
|
Standards | Relationship |
UNI EN 868-2 : 2009 | Identical |
NS EN 868-2 : 2017 | Identical |
I.S. EN 868-2:2017 | Identical |
NBN EN 868-2 : 2009 | Identical |
SN EN 868-2:2017 | Identical |
NF EN 868-2 : 2017 | Identical |
UNE-EN 868-2:2009 | Identical |
EN 868-2:2017 | Identical |
BS EN 868-2:2017 | Identical |
NEN EN 868-2 : 2017 | Identical |
EN ISO 13937-1:2000/AC:2006 | Textiles - Tear properties of fabrics - Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 13937-1:2000/Cor.1:2004) |
ISO 1974:2012 | Paper — Determination of tearing resistance — Elmendorf method |
DIN ISO 3689:1994-07 | PAPER AND BOARD - DETERMINATION OF BURSTING STRENGTH AFTER IMMERSION IN WATER |
ISO 5636-3:2013 | Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method |
ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
ISO 13937-1:2000 | Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) |
DIN ISO 5725-2:2002-12 | 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 5725-2:1994 including Technical Corrigendum 1:2002) |
EN 20811 : 1992 | TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST |
ISO 6588-2:2012 | Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction |
ISO 9237:1995 | Textiles — Determination of the permeability of fabrics to air |
ISO 9073-3:1989 | Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and elongation |
EN 1149-1:2006 | Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity |
EN ISO 9073-9:2008 | Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient (ISO 9073-9:2008) |
EN ISO 535:2014 | Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014) |
EN ISO 9237 : 1995 | TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR |
ISO 2758:2014 | Paper Determination of bursting strength |
ISO 187:1990 | Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
EN ISO 1974:2012 | Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012) |
ISO 9197:2016 | Paper, board and pulps Determination of water-soluble chlorides |
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) |
EN ISO 536:2012 | Paper and board - Determination of grammage (ISO 536:2012) |
ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
ISO 9073-9:2008 | Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient |
ISO 1924-2:2008 | Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) |
EN 29073-3:1992 | Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation |
EN 20187:1993 | Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) |
EN ISO 13938-1 : 1999 | TEXTILES - BURSTING PROPERTIES OF FABRICS - PART 1: HYDRAULIC METHOD FOR DETERMINATION OF BURSTING STRENGTH AND BURSTING DISTENSION |
ISO 2470-2:2008 | Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness) |
ISO 3781:2011 | Paper and board — Determination of tensile strength after immersion in water |
EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
ISO 536:2012 | Paper and board Determination of grammage |
ISO 3689:1983 | Paper and board — Determination of bursting strength after immersion in water |
ISO 811:1981 | Textile fabrics Determination of resistance to water penetration Hydrostatic pressure test |
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 |
EN ISO 2758:2014 | Paper - Determination of bursting strength (ISO 2758:2014) |
ISO 13938-1:1999 | Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension |
ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO 535:2014 | Paper and board — Determination of water absorptiveness — Cobb method |
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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