STANDARD

Current

ÖNORM EN ISO 10993-16

Issue date: 2018 01 15

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

General information on ÖNORM EN ISO 10993-16

Format
Paper | 25 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 10993-16 from 1998 til today.

Frequently Asked Questions about ÖNORM EN ISO 10993-16

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

Find out more about the benefits of multi-user licences

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

Find out more about getting involved in standardization

If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.

Find out more about the benefits of effects 2.0

Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 10993-1:2018
Titel
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Ausgabedatum
2018 08 17
Art
Standard

Recently Viewed

ÖNORM EN ISO 4126-3

Safety devices for protection against excessive pressure - Part 3: Safety valves and bursting disc safety devices in combination (ISO 4126-3:2020)

ÖNORM EN ISO 22553-5

Paints and varnishes - Electro-deposition coatings - Part 5: Determination of sieve residue (ISO 22553-5:2019)

ÖNORM EN 3475-805

Aerospace series - Cables, electrical, aircraft use - Test methods - Part 805: Characteristic impedance
€159.35
excl. USt.
€175.29
incl. 10% USt.
Standard
ÖNORM EN ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Customize and purchase single-user license

€159.35
excl. USt.
€175.29
incl. 10% USt.
Free delivery

Subscribe to standards

Your shopping cart is empty

Regarding the newly released ISO 9001, we recommend:

Standard
ÖNORM EN ISO 9001 - Quality management systems - Requirements (ISO 9001:2026)
View details
Seminar [Live-Online]
€749.00
excl. USt.
€898.80
incl. 20% USt.
View details
Seminar [Hybrid]
€675.00
excl. USt.
€810.00
incl. 20% USt.
View details
€49.00
excl. USt.
€58.80
incl. 20% USt.
View details
€2,419.00
excl. USt.
€2,902.80
incl. 20% USt.
View details