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:

Deliberate over ISO 10993-5 risks and secure ISO 10993-5 creativity.

– Do we cover the five essential competencies-Communication, Collaboration,Innovation, Adaptability, and Leadership that improve an organizations ability to leverage the new ISO 10993-5 in a volatile global economy?

– Marketing budgets are tighter, consumers are more skeptical, and social media has changed forever the way we talk about ISO 10993-5. How do we gain traction?

– Which ISO 10993-5 goals are the most important?

ISO 10993 Critical Criteria:

Gauge ISO 10993 quality and devote time assessing ISO 10993 and its risk.

– For your ISO 10993-5 project, identify and describe the business environment. is there more than one layer to the business environment?

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

– Can we do ISO 10993-5 without complex (expensive) analysis?

Biocompatibility Critical Criteria:

Experiment with Biocompatibility projects and reduce Biocompatibility costs.

– In the case of a ISO 10993-5 project, the criteria for the audit derive from implementation objectives. an audit of a ISO 10993-5 project involves assessing whether the recommendations outlined for implementation have been met. in other words, can we track that any ISO 10993-5 project is implemented as planned, and is it working?

– How will we insure seamless interoperability of ISO 10993-5 moving forward?

– Do ISO 10993-5 rules make a reasonable demand on a users capabilities?

Medical devices Critical Criteria:

Ventilate your thoughts about Medical devices visions and balance specific methods for improving Medical devices results.

– What prevents me from making the changes I know will make me a more effective ISO 10993-5 leader?

– How do we know that any ISO 10993-5 analysis is complete and comprehensive?

– Is ISO 10993-5 dependent on the successful delivery of a current project?


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 | theartofservice.com

[email protected]


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:

Medical Duraglide ISO 10993 – MicroCare

ISO 10993 Certified Biocompatible Resins | Entec Polymers

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

Biocompatibility External links:

Biocompatibility Testing for Medical Devices | Nelson Labs

Biocompatibility Testing Services | NAMSA

Contact Lens Biocompatibility Analysis – LSU Eye Center

Medical devices External links:

Ear, Nose & Throat (ENT) Medical Devices | ACCLARENT, …

Project and Risk Management for medical devices | Gantus AB

Altair Instruments | Medical Devices | Aesthetic Machines

Categories: Documents