The remaining sections of this guidance outline recommendations for standards development and participation that are based upon these general principles, and which will foster the development of standards that are optimized for regulatory use. Recommendations for Standards Development This section offers specific suggestions for improving standards for regulatory use and for achieving harmonization. Optimizing standards content Standards must contain objective and specific requirements that clearly indicate how conformity can be achieved and conveyed. Adherence to the following will improve standards’ content and suitability for regulatory purposes: The standard should clearly identify to a stakeholder considering its use whether and which are addressed. IMDRF EP(s) Where possible, standards should include terms and definitions that are identical to or aligned with existing terms and definitions established and accepted in other standards (see ISO/IEC Directives Part 2). Standards should have a rationale explaining the basis for the requirements in the standard that may assist in interpreting the meaning and/or purpose of the standard. The rationale should identify and explain test methods and/or other means of demonstrating compliance. In addition, the rationale should explain how conformity to the standard achieves its goal of satisfying the associated IMDRF EP(s). Scope and residual risk: the standard’s scope should clearly identify when a reasonably foreseeable risk, hazard or hazardous situation is determined to be out of the standard’s scope. When a standard identifies a hazard or a hazardous situation without giving a specific requirement for its mitigation, the standard should provide direction on how to address the resulting risk as appropriate. Standards for specific products should include specific requirements for mitigation of a hazard or hazardous situation. Standards requirements should be associated with acceptance criteria, quantitative where applicable, including instances in which clinical performance is a normative requirement. Where such criteria are absent, other ways to demonstrate conformity should be indicated. Acceptance criteria should be based on generally accepted science and technology, and where this is absent, be validated as relevant for meeting safety and performance requirements. A rationale section can provide information on the validation methods used.
The remaining sections of this guidance outline recommendations for standards development and participation that are based upon these general principles, and which will foster the development of standards that are optimized for regulatory use. Recommendations for Standards Development This section offers specific suggestions for improving standards for regulatory use and for achieving harmonization. Optimizing standards content Standards must contain objective and specific requirements that clearly indicate how conformity can be achieved and conveyed. Adherence to the following will improve standards’ content and suitability for regulatory purposes: The standard should clearly identify to a stakeholder considering its use whether and which IMDRF EP(s) are addressed. Where possible, standards should include terms and definitions that are identical to or aligned with existing terms and definitions established and accepted in other standards (see ISO/IEC Directives Part 2). Standards should have a rationale explaining the basis for the requirements in the standard that may assist in interpreting the meaning and/or purpose of the standard. The rationale should identify and explain test methods and/or other means of demonstrating compliance. In addition, the rationale should explain how conformity to the standard achieves its goal of satisfying the associated IMDRF EP(s). Scope and residual risk: the standard’s scope should clearly identify when a reasonably foreseeable risk, hazard or hazardous situation is determined to be out of the standard’s scope. When a standard identifies a hazard or a hazardous situation without giving a specific requirement for its mitigation, the standard should provide direction on how to address the resulting risk as appropriate. Standards for specific products should include specific requirements for mitigation of a hazard or hazardous situation. Standards requirements should be associated with acceptance criteria, quantitative where applicable, including instances in which clinical performance is a normative requirement. Where such criteria are absent, other ways to demonstrate conformity should be indicated. Acceptance criteria should be based on generally accepted science and technology, and where this is absent, be validated as relevant for meeting safety and performance requirements. A rationale section can provide information on the validation methods used.
imdrf-tech-181105-optimizing-standards-n51.docx