MADCAD.com - The Cloud-Based Reference Library

- Free Trial - Webinar - Feedback

Cart (0)

No items in cart.

Total

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

Not a subscriber? Register for a trial account.

Username:
Password:

Incorrect username/password.

Already a subscriber?

MADCAD.com Free Trial

Sign up for a 3 day free trial to explore the MADCAD.com interface, PLUS access the
2009 International Building Code to see how it all works.

If you like to setup a quick demo, let us know at support@madcad.com
or +1 800.798.9296 and we will be happy to schedule a webinar for you.

Email *
Password *
Confirm *
First Name *
Last Name *
Title
Company Name *
Company Size *
Industry *
Address *
Address 2
City *
State *	Zip *
Country *
Phone *
How did you hear about MADCAD.com? *

Print page(s), starting from page (current page)

Continue to Print

Reset password

Enter your personal account email address to request
a password reset:

Reset password

Enter your account email address to request
a password reset:

Save As:

Are you sure you want to delete this group?

Security check

Please check the following box:

Please login to your personal account to use this feature.

Email:

Password:

Forgot your password?

Remember me for one month

Need a login? Register now.

Please login to your authorized staff account to use this feature.

Username:

Password:

Are you sure you want to empty the cart?

There were no books found for the applied search filters.

CLICK TO START OVER

Report To Us

Please fill the form below so that we can contact you.

Full name*
Email*
Phone

Contact us for a custom quote

Please fill the form below and a member of our staff will contact you shortly. The contents of your cart will automatically be sent to us so we can provide an accurate custom quote.

Company*
Full name*
Email*
Phone

⨯To continue with accurate pricing,
please select your company type below:

Large goverment organizations

Large multi-national corporation (more than $5B annual revenue)

None of the above

Your company has a special pricing case for IEEE.
For pricing, please contact us by filling out the form.

Full name*
Email*
Phone
Your selection

⨯We need your input!

Are you a code official in a jurisdiction with less than 300,000 population?

Yes No

This item is only available for the code officials of jurisdictions less then 300K population.

If you do not meet the criteria item will be removed and you will be able to continue shopping other items.

⨯ We need your input!

Your company has a special pricing case for ASME.
Please make sure the information you provide below is accurate.

Company Industry
Number Of Employees
Revenue

Pricing for the ASME publications in the store is for a 1-4 employee company in Construction Industry with revenue under $500,000.
If correct company info does not match what is publicly available info we will suspend the access and contact you for correction.
Please call 1-800-798-9296 if you have any questions.
If your company has more than 5,000 employee or more than 500 mil revenue please email us at info@madcad.com to receive a special quote, use "ASME Quote" on the subject line.

Cart Warning

Search book title

Search book content

Clear all filters Advanced Search Basic Search

Download File

eLibrary > 17/30344601 DC BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process >

17/30344601 DC BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process, 2017

Expand All

TOC Search:

17/30344601 DC BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process, 2017

ISO_DIS_10993-1_(E).pdf [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation of medical devices
5 Categorization of medical devices
5.1 General
5.2 Categorization by nature of body contact
5.2.1 Non-contacting devices
5.2.2 Transient-contacting devices
5.2.3 Surface-contacting devices
5.2.4 External communicating devices
5.2.5 Implant devices
5.3 Categorization by duration of contact
6 Biocompatibility evaluation process
6.1 Biological risk assessment
6.1.1 Physical and chemical information
6.1.2 General: Gap analysis and selection of biological endpoints for assessment
6.1.3 Biological testing
7 Interpretation of biological evaluation data and overall biological safety assessment
Annex A (informative) Endpoints to be addressed in a biological risk assessment
Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process
Annex C (informative) Suggested procedure for literature review
Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
Bibliography [Go to Page]

About Us / Careers / support@madcad.com / 1.800.798.9296

MADCAD.com Free Trial

Report To Us

Contact us for a custom quote

⨯To continue with accurate pricing, please select your company type below:

⨯We need your input!

⨯ We need your input!

Cart Warning

17/30344601 DC BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process, 2017

⨯To continue with accurate pricing,
please select your company type below: