I.S. EN ISO 22413:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS (ISO 22413:2010)
Hardcopy , PDF
22-07-2021
English
01-01-2013
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.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Design and designation
4 Material
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Testing of physical requirements
9 Testing of chemical requirements
10 Testing of biological requirements
11 Packaging
12 Storage
13 Labelling
Annex A (normative) - Testing of fragmentation of transfer
sets with plastic piercing devices
Annex B (normative) - Testing of fragmentation of transfer
sets with metal piercing devices
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
Pertains to sterilized single use transfer sets that are used for pharmaceutical preparations.
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 22413:2013 | Identical |
| ISO 22413:2010 | Identical |
| ISO 15759:2005 | Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process |
| DIN 13097-4:2009-08 | HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 1707:1996 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ISO 15747:2010 | Plastic containers for intravenous injections |
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