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BS EN ISO 22413:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Transfer sets for pharmaceutical preparations. Requirements and test methods
Available format(s)

Hardcopy , PDF

Superseded date

29-06-2021

Language(s)

English

Published date

30-04-2013

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.

ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Committee
CH/212
DevelopmentNote
Supersedes BS ISO 22413. (06/2011)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
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Superseded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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$407.85
Including GST where applicable

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