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What is the current version of ISO 10993?

What is the current version of ISO 10993?

ISO 10993-18:2020.

What is the latest version of ISO 10993-1?

EN ISO 10993-1:2020.

How many ISO 10993 are there?

To date, 12 ISO 10993 standards have been issued by the committee: 10993-1: “Guidance on Selection of Tests.”

What is the ISO 10993 used for?

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices.

How many parts are in the ISO 10993 under the general title biological evaluation of medical devices?

ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: — Part 1: Evaluation and testing within a risk management process. — Part 2: Animal welfare requirements. — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

How long does sensitization testing take?

TEST METHODS Guinea pig sensitization tests require six to eight weeks and thus take the longest time to complete of all the acute biocompatibility tests described in the 10993 standards.

What is USP Class VI?

USP Class VI refers to a set of biocompatibility testing requirements from the U.S. Pharmacopeia (USP), a non-profit organization whose standards inform decision-making at the U.S. Food and Drug Administration (FDA).

What does IEC 60601 1 compliant mean?

IEC 60601-1 provides general requirements, in a series of standards, that address the basic safety and essential performance requirements of medical electrical equipment.

What is biological evaluation report medical devices?

A biological evaluation report (BER) is a collective summary of data used to demonstrate how compatible a medical device is with the human body. In other words, the BER provides evidence of a medical device’s biological safety, known as biocompatibility.

What is Ber in medical devices?

What is the difference between irritation and sensitization?

Allergic contact dermatitis (ACD) is a common skin disease with a significant social and economic impact. In contrast to irritation, skin sensitization is a response of the adaptive immune system, in which there is a delayed T-cell-mediated allergic response to chemically modified skin proteins.

How do you test for sensitization?

Skin sensitization testing is traditionally performed using either human tests such as the human repeat insult patch test and the human maximization test or animal tests such as the murine local lymph node assay (LLNA), the guinea pig maximization test, and the Buehler test (OECD 1992; OECD 2010a).