NF EN ISO 10993-16

NF EN ISO 10993-16

August 2009
Standard Cancelled

Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

View the extract New: UPSELL service
Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

24 p.

Reference

NF EN ISO 10993-16

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-16

Print number

1 - 20/07/2009

International kinship

ISO 10993-16:1997

European kinship

EN ISO 10993-16:2009
Replaced standards (1)
NF EN ISO 10993-16
November 1997
Standard Cancelled
Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables.

Standard replaced by (1)
NF EN ISO 10993-16
July 2010
Standard Cancelled
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
New: UPSELL service
- The UPSELL service allows you to easily update one of your standards.
- With a single click, add a new language, the Requirements or Redline+ service and add one or more additional users.
- Whether you are in the process of acquiring a standard or it is already available in your personal space, the UPSELL service is available at every stage to help you understand it and implement it within your organization.
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ