Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Home
Content
Tour
eLibrary
Store
Search book title
Filters:
BOOKS
All Books
PACKAGES
All Packages
EDITION
to
PUBLISHER
BSI
(40)
ISO
(10)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Product - Data Sheet
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Sustainability
 Technical Bulletin
 All
  • ASTM
    F1841-19e1 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
    Edition: 2019
    $144.00
    Unlimited Users per year

Description of ASTM-F1841 2019

ASTM F1841-19e1

Historical Standard: Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps




ASTM F1841

Scope

1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. Adopting current practices for this assessment, a 6-hour in vitro test is performed on a pump placed in a device-specific recirculating blood loop that mimics the pressure and flow conditions of the expected worst-case clinical use of the device. If the ultimate goal of the testing is to evaluate the blood damage potential of a pump for clinical use, it is suggested that paired testing between the subject blood pump and a legally marketed comparator device be conducted using the same blood pool in a matched blood test loop so that a relative hemolysis comparison can be made.

1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

blood pump; blood trauma; index of hemolysis; modified index of hemolysis (MIH); normalized index of hemolysis (NIH); plasma free hemoglobin concentration (PfH);


ICS Code

ICS Number Code 11.100 (Laboratory medicine)


DOI: 10.1520/F1841-19E01



This book also exists in the following packages...

Year Publisher Title Annual Price
VAR
ASTM
 [+] $1,177.11 Buy
VAR
ASTM
 [+] $1,961.46 Buy

Subscription Information

MADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

Some features of MADCAD.com ASTM Standards Subscriptions are:

- Online access: With MADCAD.com’ s web based subscription service no downloads or installations are required. Access ASTM Standards from any browser on your computer, tablet or smart phone.

- Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.

 

For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
GROUPS
X