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Don't put your consumers and patients in harm's way. Ensure your medical devices are tried and tested prior to marketing and use with the new OBP collection for biological evaluation.

Painful skin irritations, rashes and eye infections due to the chemicals and plastics used in medical devices (health or medical instruments) are preventable. Whether for items as simple as a tongue depressor or as complicated as prosthetic limbs or implantable drug delivery pumps, look no further than this latest collection to minimize patient hazards and maximize treatment.

This new collection for biological evaluation of medical devices contains all the parts of ISO 10993 that manufacturers, researchers, laboratories, and regulators involved in development, testing or approval should not be without!

Access all the standards in one convenient location on the OBP and improve:

  • The quality of medical and dental devices
  • The safety of patients
  • The basis for testing and certification

As an added bonus, the collection includes ISO/TR 15499 on how to plan and conduct the biological evaluation of a medical device and, more importantly, how such an evaluation sits within the activities of design control and risk management.


Benefits of online collections

With an ISO online collection, you are always guaranteed:

  • The most up-to-date content: when a change is made to a standard in the collection, your online library is updated immediately
  • Easy navigation: moving between standards has never been easier with embedded links that let you "jump" from one standard to another
  • Universal access: you can access your library from any computer or tablet as long as you have an Internet connection


This online collection is available from ISO members with an ISOlutions webstore.
Please contact the ISO member in your country to see if they offer this, or a similar, product.


Related information

Contact

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Elizabeth Gasiorowski-Denis

+41 22 749 03 25

Standards


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Katie Bird
Head, Communication

+41 22 749 0431

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