Get the New 3rd Edition of ISO 14155

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice, is now in it’s third edition. You can pick up your copy from our website in either Paper of PDF format. This standards is eligible for our Standards Online Subscription Service. Ask for your quote today.

This document is a good reference for the conduct, design, recording and reporting of clinical investigation. It can be used to asses the performance, effectiveness, or safety of medical devices. This standard addresses a few specific general requirements with the intention to:

  • protect the rights, safety, and well being of the patient
  • it ensures the scientific conduct of clinical investigation in a credible manor
  • defines the responsibilities of investigator
  • aids investigators or other regulatory authorities in the conformity assessment of medical devices
Image by Pasi Mäenpää from Pixabay

Note: Please check to see if there are other standards that apply to your the investigation, other documents might be more relevant than this one. This document does not apply to in vitro devices, unless otherwise specified. This document does not apply to in vitro devices, unless otherwise specified. This document also makes references to ISO 14971

The Changes

This document completely replaces the second edition. According to the publisher, the changes to this document include the following

  • summary section of GCP principles
  • references of registration of the clinical investigation in a publicly accessible database
  • clinical quality management
  • risk based-monitoring
  • statistical considerations
  • guidance for ethics committees
  • risk management throughout the process of a clinical investigation
  • clarification of applicability of this document
  • guidance on clinical investigations audits

You can grab your copy from our web store. We offer both printed and pdf format. This document is also available for on our Standards Online Subscription service. You can read more about our Standards Online Service on a previous post. We offer a 14 day trial so that you can determine if this service is right for you. Ask us today!

New Standards on Properties Of Surfaces for Q1 of 2020

This is a list of standards on properties of surfaces that were updated in the first quarter of 2020. If you would like to view a complete list on the subject, check it out here. To search other standards by ICS or subject, check out our complete list here. Please note that links for standards that have been replaced or renumbered will take you directly to the most recent replacement.

Most of these standards will be available for purchase through our standards online service. This service is especially great if you have a big team that needs to share a standard. Instead of buying multiple copies for a team, you will only need to pay for one site. Add as many people as you like and they can access it anywhere anytime. For more on this service, check out a complete description here or ask us today!

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New Standards on Anaesthetic, Respiratory And Reanimation Equipment Including Medical Gas Installations Q1 of 2020

This is a list of all the standards that were updated in the first quarter of 2020. The list is alphabetical. Documents that have been replaced will link to its replacement. A complete list on the subject can be found here.

Some of these standards are available for our subscription service. Documents purchased this way are uploaded to a personalized website so you and your team can access the standards you need anywhere. For more information, read here. For all our other services to help you keep compliant, check out a full list here.

To search up other standards by ICS subject check here.

New Standards on Health Care Technology for Q1 of 2020

Here is a list of all the updates for standards on health care technology for the first quarter this year. Follow us for more updates!

To search other standards by subject, go here!

New Standards on Lubrication, Industrial Oils and Related Products 1st Quarter of 2020

You can grab your copies of the new standards on lubrication, industrial oils and related products from us today! Order now

To Search other standards by subject, go here

ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

Photo by Angel Norris from FreeImages

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

  • a clause on normative references to respect requirements for fixed ISO/IEC directives
  • terms have been updated to match up with ISO/IEC Guide 63:2019
  • Definitions of certain terms such as benefit, state of the art have been added
  • More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
  • The process descruved can be used for managing risk
  • Requirements to disclose residual risks have been merged into one requirement
  • Results of reviews is now risk management report
  • Requirements for production and post production activities have been restructured and clarified.
  • Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

This document is part of our yearly subscription service, StandardsOnline. We make it easy for you and your team to access the same document without the hassle of buying multiple copies. If you would like to learn more about this service, go here.

New ISO 14045 on Environmental management — Eco-efficiency assessment of product systems — Principles, requirements and guidelines

ISO has just released a new standard in the 14000 series: ISO 14045, “Environmental management — Eco-efficiency assessment of product systems — Principles, requirements and guidelines.”  Eco-efficiency assessment is a quantitative management tool which enables the study of life-cycle environmental impacts of a product system along with its product system value for a stakeholder.

The document has already been adopted by the European Union, with the official English language edition (BS EN ISO 14045) in print as well.  The standard is available in either the ISO or EN editions  from Document Center Inc. now.

Within eco-efficiency assessment, environmental impacts are evaluated using Life Cycle Assessment (LCA) as prescribed by other International Standards (ISO 14040, ISO 14044). Consequently, eco-efficiency assessment shares with LCA many important principles such as life cycle perspective, comprehensiveness, functional unit approach, iterative nature, transparency and priority of a scientific approach.

The value of the product system may be chosen to reflect, for example, its resource, production, delivery or use efficiency, or a combination of these. The value may be expressed in monetary terms or other value aspects.

The key objectives of ISO 14045:2012 are to:
— establish clear terminology and a common methodological framework for eco-efficiency assessment;
— enable the practical use of eco-efficiency assessment for a wide range of product (including service) systems;
— provide clear guidance on the interpretation of eco-efficiency assessment results;
— encourage the transparent, accurate and informative reporting of eco-efficiency assessment results.

This new standard, and all ISO standards, are available from Document Center Inc. at our website,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (  Our expert staff is here to assist you with your standards requirements and questions.

ISO 50001 2011 Edition tackles the problem of Energy management systems – Requirements with guidance for use

The new ISO 50001:2011 specifies requirements for establishing, implementing, maintaining and improving an energy management system.  The new document, titled “Energy management systems — Requirements with guidance for use,” is expected to be adopted by the European Union as EN-ISO-50001 and will replace EN-16001.

ISO 50001:2011 specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance.  And Annex A provides informative guidance on its use.

The ISO standard applies to all variables affecting energy performance that can be monitored and influenced by the organization. However, it does not prescribe specific performance criteria with respect to energy.

ISO 50001 has been designed to be used independently, but it can be aligned or integrated with other management systems.

It is applicable to any organization wishing to ensure that it conforms to its stated energy policy and wishing to demonstrate this to others, such conformity being confirmed either by means of self-evaluation and self-declaration of conformity, or by certification of the energy management system by an external organization.

Energy management can reduce energy consumption, leading to:

  • Reduced energy costs
  • Reduced carbon emissions
  • A more secure supply of energy
  • Improved reputation when implemented with certification
  • ISO 50001 enables organizations to take a systematic approach to energy management. It’s goal is to help companies achieve continual improvement of energy performance, energy efficiency and energy conservation.

    Who should buy this standard?

  • Anyone who wants to reduce their energy costs, reduce carbon emissions or improve their organization’s reputation
  • Those who want a better understanding of international best practice energy management
  • Users of ISO 14001 who want to further develop their management of energy and increase their performance and savings
  • Those responsible for planning and implementing an energy management system
  • ISO 50001:2011 is available from Document Center Inc. at our website,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (   We have been an authorized distributor of ISO standards since the 1990’s.