Dutch technical specification (NTA 8070) on devices for assisted reproductive technologies.

摘要

In 2006 the Dutch Society for Clinical Embryologists (KLEM) approached the Netherlands Standardisation Institute (NEN) for advice regarding the lack of safety and quality specifications for medical devices used in assisted reproductive technology. A project plan was drafted in accordance with NEN-standardized methods for the development of norms and Dutch technical specifications (NTA) and a working group was launched consisting of all interested parties. A framework was then set up to develop an NTA that focused on the safety of gametes, embryos and the unborn offspring. The three main parts of the NTA describe the classification of medical devices, the requirements for new and existing devices and testing methods. The content of the NTA can be considered mainly as a consensus of the participants in the working group from both industry and clinical embryologists (KLEM). A final draft was sent to representatives from or allied to the government and to a notified body, and NTA 8070, entitled Devices for Assisted Reproductive Technologies (ART), was issued in March 2008.