Top 11 ISO 10993-12 Questions to Grow

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:

Investigate ISO 10993-12 risks and get going.

– Will ISO 10993-12 have an impact on current business continuity, disaster recovery processes and/or infrastructure?

– What role does communication play in the success or failure of a ISO 10993-12 project?

ISO 10993 Critical Criteria:

Look at ISO 10993 adoptions and perfect ISO 10993 conflict management.

– How do we know that any ISO 10993-12 analysis is complete and comprehensive?

– What is the purpose of ISO 10993-12 in relation to the mission?

– What are the business goals ISO 10993-12 is aiming to achieve?

Biocompatibility Critical Criteria:

Contribute to Biocompatibility adoptions and handle a jump-start course to Biocompatibility.

– How can we incorporate support to ensure safe and effective use of ISO 10993-12 into the services that we provide?

– Is ISO 10993-12 Realistic, or are you setting yourself up for failure?

– Think of your ISO 10993-12 project. what are the main functions?

Medical devices Critical Criteria:

Rank Medical devices goals and find the essential reading for Medical devices researchers.

– what is the best design framework for ISO 10993-12 organization now that, in a post industrial-age if the top-down, command and control model is no longer relevant?

– Where do ideas that reach policy makers and planners as proposals for ISO 10993-12 strengthening and reform actually originate?

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


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 |

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

Medical Duraglide ISO 10993 – MicroCare

MassMEDIC Webinar: ISO 10993 Update: Understanding …

Biocompatibility External links:

Biocompatibility Testing Services | NAMSA

Medical devices External links:

FDA Medical Devices – Official Site