10 ISO 10993-12 Success Criteria

What is involved in ISO 10993-12

Find out what the related areas are that ISO 10993-12 connects with, associates with, correlates with or affects, and which require thought, deliberation, analysis, review and discussion. This unique checklist stands out in a sense that it is not per-se designed to give answers, but to engage the reader and lay out a ISO 10993-12 thinking-frame.

How far is your company on its ISO 10993-12 journey?

Take this short survey to gauge your organization’s progress toward ISO 10993-12 leadership. Learn your strongest and weakest areas, and what you can do now to create a strategy that delivers results.

To address the criteria in this checklist for your organization, extensive selected resources are provided for sources of further research and information.

Start the Checklist

Below you will find a quick checklist designed to help you think about which ISO 10993-12 related domains to cover and 10 essential critical questions to check off in that domain.

The following domains are covered:

ISO 10993-12, ISO 10993, Biocompatibility, Medical devices:

ISO 10993-12 Critical Criteria:

Have a round table over ISO 10993-12 quality and triple focus on important concepts of ISO 10993-12 relationship management.

– How do we Identify specific ISO 10993-12 investment and emerging trends?

– What are the Key enablers to make this ISO 10993-12 move?

– What is our ISO 10993-12 Strategy?

ISO 10993 Critical Criteria:

Use past ISO 10993 risks and find the ideas you already have.

– Do several people in different organizational units assist with the ISO 10993-12 process?

– Is ISO 10993-12 dependent on the successful delivery of a current project?

– What are specific ISO 10993-12 Rules to follow?

Biocompatibility Critical Criteria:

Scrutinze Biocompatibility leadership and maintain Biocompatibility for success.

– Does ISO 10993-12 include applications and information with regulatory compliance significance (or other contractual conditions that must be formally complied with) in a new or unique manner for which no approved security requirements, templates or design models exist?

– A compounding model resolution with available relevant data can often provide insight towards a solution methodology; which ISO 10993-12 models, tools and techniques are necessary?

Medical devices Critical Criteria:

Judge Medical devices risks and explore and align the progress in Medical devices.

– What are your key performance measures or indicators and in-process measures for the control and improvement of your ISO 10993-12 processes?

– What is Effective ISO 10993-12?


This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the ISO 10993-12 Self Assessment:


Author: Gerard Blokdijk

CEO at The Art of Service | theartofservice.com



Gerard is the CEO at The Art of Service. He has been providing information technology insights, talks, tools and products to organizations in a wide range of industries for over 25 years. Gerard is a widely recognized and respected information expert. Gerard founded The Art of Service consulting business in 2000. Gerard has authored numerous published books to date.

External links:

To address the criteria in this checklist, these selected resources are provided for sources of further research and information:

ISO 10993-12 External links:

EVS-EN ISO 10993-12:2012 – Estonian Centre for …

ISO 10993 External links:

A Practical Guide to ISO 10993-5: Cytotoxicity | MDDI Online

A Practical Guide to ISO 10993-10: Irritation | MDDI Online

Biocompatibility External links:

Biocompatibility Testing for Medical Devices | Nelson Labs

Biocompatibility Testing Services | NAMSA

Medical devices External links:

Medical Devices Products | Johnson & Johnson

Medical Devices – Food and Drug Administration