Customer Support: +44 (0)203 327 3140

Login to i2i Subscription Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

DIN EN ISO 3826-4 E : 2015

Current
Current

The latest, up-to-date edition.

PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Design
6 Requirements
7 Packaging
8 Labelling
9 Anticoagulant and/or preservative solution
Annex A (normative) - Chemical tests
Annex B (normative) - Physical tests
Annex C (normative) - Biological tests
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical devices
Bibliography

Defines requirements including performance requirements for aphaeresis blood bag systems with integrated features.

DocumentType
Standard
Pages
43
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 3826-4:2015 Identical
EN ISO 3826-4:2015 Identical

ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
DIN EN ISO 3826-2:2008-11 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 2: GRAPHICAL SYMBOLS FOR USE ON LABELS AND INSTRUCTION LEAFLETS
DIN EN ISO 10993-11 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
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
DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
ISO 15747:2010 Plastic containers for intravenous injections
DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

View more information
£125.21
Excluding VAT
GBP
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

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.

Learn more on subscription solutions

or

Get in touch with us