I.S. EN 868-4:2017
Current
The latest, up-to-date edition.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
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 (normative) - Method for the determination of ph
value, chloride and sulphate 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
Defines 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.
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NS 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 |
| DIN EN 868-4:2017-05 | Equivalent |
| ONORM EN 868-4 : 2017 | Identical |
| UNE-EN 868-4:2017 | Identical |
| DIN EN 868-4:2017-05 | 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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