BS-EN-ISO-10993-1 › Biological evaluation of medical devices
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
What is BS EN ISO 10993-1:October 2009?
The main objective of BS EN ISO 10993-1 is to protect people from potential biological hazards that could arise from the use of medical instruments or medical technology. The standard contains a variety of guidelines that relate to the biological analysis and testing of medical devices, such as dental equipment and surgical implants. It has been compiled to test medical instruments within a risk management process – as part of the overall evaluation and development of each device.
How does it work?
The general principles set out in BS EN ISO 10993 were developed to help organisations or individuals to do a biological evaluation of medical equipment within a risk management process. The standard looks at the general classification of devices based on their nature and duration of contact with the body. It also explains the evaluation of existing and relevant data from all sources, before identifying information gaps. BS EN ISO 10993 also shares best practice recommendations to do a full assessment of the biological safety of medical instruments.
Who should buy it?
Anyone responsible for the biological evaluation of medical equipment
Manufacturers of medical instruments, dental equipment and implants
Suppliers of medical equipment
Cytotoxicity tests;Bioassay;Clinical investigation instruments;Dental materials;Medical equipment;Compatibility;Implants (surgical);Biological hazards;Biological analysis and testing;Medical instruments;Dental equipment;Contaminants;Medical technology
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Medical devices. Quality management systems. Requirements for regulatory purposes
Standard Test Method for Seal Strength of Flexible Barrier Materials
BS EN ISO 10993-1:2020
Dec. 16, 2020
BS EN ISO 10993-1:October 2009;BS EN ISO 10993-1:October 2009
FprEN ISO 10993-1;ISO 10993-1:2018