11 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 11 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:

Deliberate ISO 10993-12 outcomes and catalog what business benefits will ISO 10993-12 goals deliver if achieved.

– Are there any easy-to-implement alternatives to ISO 10993-12? Sometimes other solutions are available that do not require the cost implications of a full-blown project?

– How do your measurements capture actionable ISO 10993-12 information for use in exceeding your customers expectations and securing your customers engagement?

– What knowledge, skills and characteristics mark a good ISO 10993-12 project manager?

ISO 10993 Critical Criteria:

Learn from ISO 10993 risks and oversee ISO 10993 requirements.

– What tools do you use once you have decided on a ISO 10993-12 strategy and more importantly how do you choose?

– How do mission and objectives affect the ISO 10993-12 processes of our organization?

– Can we do ISO 10993-12 without complex (expensive) analysis?

Biocompatibility Critical Criteria:

Discuss Biocompatibility planning and report on setting up Biocompatibility without losing ground.

– What are our needs in relation to ISO 10993-12 skills, labor, equipment, and markets?

– Does our organization need more ISO 10993-12 education?

Medical devices Critical Criteria:

Jump start Medical devices risks and probe using an integrated framework to make sure Medical devices is getting what it needs.

– How likely is the current ISO 10993-12 plan to come in on schedule or on budget?

– Is a ISO 10993-12 Team Work effort in place?


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 External links:

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

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

Biocompatibility External links:

Biocompatibility Test Services – Nelson Labs

Toxicology & Biocompatibility | Nelson Labs

Medical devices External links:

Medical Devices – U.S. Food and Drug Administration