BS EN ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

BS EN ISO 10993-1:2020

Biological evaluation of medical devices. Evaluation and testing within a risk management process

Status : Current   Published : December 2020



BS EN ISO 10993-1:2020 also available with tracked-changes. To learn more and buy, click HERE.

What is BS EN ISO 10993-1:2020 about?

A biological evaluation needs to be done before any medical device can interact with the human body. BS EN ISO 10993-1:2020 helps users plan and conduct such biological evaluations reliably and cost-effectively.

Who is BS EN ISO 10993-1:2020 for?

  • Medical device manufacturers
  • Test laboratories
  • Regulators
  • Notified Bodies

Why should you use BS EN ISO 10993-1:2020?

It provides a framework for planning and conducting biological evaluations of medical devices.

The revision underlines that the standard is not about test selection but about the collection and evaluation of all types of data that are relevant to biological safety. This should lead to more reliable and cost effective evaluations.

BS EN ISO 10993-1:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages because it underpins the use of safe medical devices.

What’s new about BS EN ISO 10993-1:2020?

The standard was revised to minimize the use of test animals by preferring in vitro models and material characterization.

Annex A has been changed to include physical and/or chemical information as part of the endpoints to be addressed in a biological risk assessment. This has now become a prerequisite for any risk assessment.

Guidance on the conduct of biological evaluation within a risk management process has been expanded to include material characterization concepts.

Standard NumberBS EN ISO 10993-1:2020
TitleBiological evaluation of medical devices. Evaluation and testing within a risk management process
Publication Date16 December 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-11:2017, ISO 10993-2:2006, ISO 14971:2007, ISO 10993-3, ISO 10993-9, ISO 10993-16, ISO 10993-4, ISO 10993-14, ISO 10993-17, ISO 10993-13, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-15, ISO 10993-7, ISO/TS 10993-20, ISO 10993-18, ISO 10993-12
Informative References(Provided for Information)ISO 9000, ISO 9001, ISO 7405, ISO/TR 10993-33, ISO 9004, ISO/TR 10993-19, ISO 18562 (all parts), ISO/IEC 17025, ISO/TR 10993-22, ISO 13485:2016
International RelationshipsEN ISO 10993-1:2020,ISO 10993-1:2018
Draft Superseded By17/30344601 DC
DescriptorsMedical technology, Compatibility, Cytotoxicity tests, Contaminants, Medical equipment, Bioassay, Implants (surgical), Biological analysis and testing, Dental materials, Biological hazards, Medical instruments, Clinical investigation instruments, Dental equipment
Title in FrenchÉvaluation biologique des dispositifs médicaux Évaluation et essais au sein d'un processus de gestion du risque
Title in GermanBiologische Beurteilung von Medizinprodukten Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems
ISBN978 0 580 94868 8
File Size1.558 MB

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