Customer Support: +353 (0)1 857 6730

Corporate Website About Us
  • There are no items in your cart
Please enter a keyword to search
Advanced search
Home
CEN
EN ISO 22413:2013

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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)

Superseded date

30-06-2021

Superseded by

EN ISO 22413:2021

Published date

06-02-2013

Publisher

Comite Europeen de Normalisation

Sorry this product is not available in your region.

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

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

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Get in touch with us