BS EN ISO 16061:2021

What is ISO 16061 about?

ISO 16061 is one of a series of documents for instruments for use in association with non-active surgical implants that specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. And applies to instruments that can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

ISO 16061 gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

Note: ISO 16061 is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

Who is ISO 16061 for?

ISO 16061 is applicable to-

• Manufacturers and suppliers of non-active surgical implants
• Test laboratories for non-active surgical implants
• Healthcare facilities

Why should you use ISO 16061?

ISO 16061 discusses three levels of standards dealing with instruments to be used in association with non-active surgical implants. They are as follows, with level 1 being the highest. Level 1: general requirements for instruments to be used in association with non-active surgical implants, Level 2: requirements for families of instruments to be used in association with non-active surgical implants. Level 3: Specific requirements for types of instruments to be used in association with non-active surgical implants.

ISO 16061 provides a method of addressing the fundamental principles outlined in ISO/TR 14283 as they apply to instruments to be used in association with non-active surgical implants. It also provides a method that can be used to demonstrate compliance with applicable regulatory requirements relevant to the general safety and performance of medical devices as they apply to instruments used in association with non-active surgical implants.

What’s changed since the last update?

BS EN ISO 16061:2021 supersedes ISO 16061:2015, which has been withdrawn. BS EN ISO 16061:2021 has some significant changes with respect to ISO 16061:2015, these include:

• requirement to include intended purpose has been added in the list of items to be included when establishing the intended performance of the instrument
• The list of design attributes in clause 5 has been reorganized and several new attributes have been added to the list
• The selection of materials to be used in the instrument has been based on a risk analysis and the clause now includes a list of the minimum factors to be considered in the risk analysis
• The requirement for pre-clinical evaluation has been expanded and includes the requirement for testing and biological evaluation of the final instrument.
• A clinical evaluation of the instrument has been added as a requirement in all cases. However, if the pre-clinical evaluation demonstrates the safety and intended performance of the instrument in the conditions of intended use, the results of the pre-clinical evaluation will satisfy the requirement for the clinical evaluation
• A new requirement for post-market surveillance has been added to clause 7