Top 11 ISO 10993-12 Criteria for Ready Action

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:

Distinguish ISO 10993-12 decisions and stake your claim.

– What are the success criteria that will indicate that ISO 10993-12 objectives have been met and the benefits delivered?

– How to Secure ISO 10993-12?

ISO 10993 Critical Criteria:

Talk about ISO 10993 goals and innovate what needs to be done with ISO 10993.

– For your ISO 10993-12 project, identify and describe the business environment. is there more than one layer to the business environment?

– Will ISO 10993-12 deliverables need to be tested and, if so, by whom?

– Are there ISO 10993-12 problems defined?

Biocompatibility Critical Criteria:

Deduce Biocompatibility visions and define what our big hairy audacious Biocompatibility goal is.

– How do you determine the key elements that affect ISO 10993-12 workforce satisfaction? how are these elements determined for different workforce groups and segments?

– Do those selected for the ISO 10993-12 team have a good general understanding of what ISO 10993-12 is all about?

– Why are ISO 10993-12 skills important?

Medical devices Critical Criteria:

Apply Medical devices engagements and probe using an integrated framework to make sure Medical devices is getting what it needs.

– What prevents me from making the changes I know will make me a more effective ISO 10993-12 leader?

– Is there a ISO 10993-12 Communication plan covering who needs to get what information when?


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 10993-12 External links:

EVS-EN ISO 10993-12:2009 – Estonian Centre for …

ISO 10993 External links:

MassMEDIC Webinar: ISO 10993 Update: Understanding …

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

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

Biocompatibility External links:

Biocompatibility Testing for Medical Devices | Nelson Labs

Biocompatibility Testing Services | NAMSA

Medical devices External links:

Medical Devices – Food and Drug Administration