12 Extremely Powerful ISO 10993-5 Questions You Do Not Know

What is involved in ISO 10993-5

Find out what the related areas are that ISO 10993-5 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 10993-5 thinking-frame.

How far is your company on its ISO 10993-5 journey?

Take this short survey to gauge your organization’s progress toward ISO 10993-5 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 10993-5 related domains to cover and 12 essential critical questions to check off in that domain.

The following domains are covered:

ISO 10993-5, ISO 10993, Biocompatibility, Medical devices:

ISO 10993-5 Critical Criteria:

Scrutinze ISO 10993-5 adoptions and forecast involvement of future ISO 10993-5 projects in development.

– Is the ISO 10993-5 organization completing tasks effectively and efficiently?

– Who sets the ISO 10993-5 standards?

– Why are ISO 10993-5 skills important?

ISO 10993 Critical Criteria:

Substantiate ISO 10993 visions and observe effective ISO 10993.

– How do you incorporate cycle time, productivity, cost control, and other efficiency and effectiveness factors into these ISO 10993-5 processes?

– What may be the consequences for the performance of an organization if all stakeholders are not consulted regarding ISO 10993-5?

– Have you identified your ISO 10993-5 key performance indicators?

Biocompatibility Critical Criteria:

Tête-à-tête about Biocompatibility engagements and differentiate in coordinating Biocompatibility.

– Why is it important to have senior management support for a ISO 10993-5 project?

– How do we maintain ISO 10993-5s Integrity?

– Is ISO 10993-5 Required?

Medical devices Critical Criteria:

Collaborate on Medical devices risks and inform on and uncover unspoken needs and breakthrough Medical devices results.

– Think about the kind of project structure that would be appropriate for your ISO 10993-5 project. should it be formal and complex, or can it be less formal and relatively simple?

– How do your measurements capture actionable ISO 10993-5 information for use in exceeding your customers expectations and securing your customers engagement?

– Is a ISO 10993-5 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 10993-5 Self Assessment:


Author: Gerard Blokdijk

CEO at The Art of Service | http://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 10993-5 External links:

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

ISO 10993 External links:

Biocompatibility Testing & ISO 10993 Tests – Pacific Biolabs

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

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

Biocompatibility External links:

Toxicology & Biocompatibility | Nelson Labs

Biocompatibility Testing for Medical Devices | Nelson Labs

Medical devices External links:

Medical Devices – U.S. Food and Drug Administration