New ISO/TR 24971 provides guidance for ISO 14971

The new ISO/TR 24971, “Medical devices – Guidance on the application of ISO 14971,” has been released.  The ISO/TR 24971 was written to address the difficulties that some folks have in implementing particular clauses of the ISO 14971.  It supplements the guidance already found in the ISO 14971, so if you’re using that ISO standard you may want to get a copy of this new Technical Report.

Guidance on the following particular areas are addressed in the new Technical Report:

  • The role of international product safety and process standards in risk management,
  • Policy development for risk acceptability criteria,
  • Integrating production and post-production feedback loops into risk management,
  • How to differentiate information for safety as a risk control measure vs. the disclosure of residual risk, and
  • Evaluation of overall residual risk.

ISO/TR 24971 also suggests some alternative approaches for implementing and maintaining a risk management system for ISO 14971.

All this stems from the fact that the use of ISO 14971 sets a acceptable risk threshold for hazards and hazardous situations unless there is objective evidence to the contrary.  This means a medical device company has to document how they identified those hazards/hazardous situations and also monitor potential “evidence to the contrary.”

ISO/TR 24971 provides the user with 12 pages of detailed questions to review, decision flow charts, and discussions of the factors listed above.  It will surely assist medical device manufacturers meet the issues recently identified in the informational annexes of the European adoptions of ISO 14971.

Document Center Inc. has been providing customers with copies of the ISO standards under license agreement since the 1980’s.  You can purchase your copies at our web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Some territorial restrictions may apply.

You’ll also be happy to know that each purchase comes with our free regular notification service.  Your list of standards is reviewed against our database every two to three weeks and if there are changes, you’re automatically notified by email.  We even have premium services that check on a nightly basis.

If you’re in the Medical Device business, you need to know about the changes to the standards you use.  But you also need to know about new releases like the ISO/TR 24971.  That’s why you should be using Document Center — We’re Your Standards Experts!

New ISO/TR 15499 standard available on Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

ISO/TR 15499:2012, “Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process,” has just been released and is now available from Document Center Inc.  The new Technical Report provides guidance on conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

This document can be used to better understand the requirements of ISO 10993-1 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 10993-1.  Biological evaluation is a design verification activity which is set in the context of broader risk management processes. This means ISO/TR 15499 includes guidance on the application of ISO 10993-1 in the context of risk management processes conducted according to the requirements of ISO 14971.

Guidance contained in this Technical Report can also be useful as background information for those representing risk management process assessors, conformity assessment bodies and regulatory enforcement bodies.

ISO standards are sold by Document Center Inc. under license agreement at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with the standards questions and requirements that affect your business.

New BS EN ISO 14971 2012 Edition released on Medical devices. Application of risk management to medical devices

BS EN ISO 14971:2012, “Medical devices. Application of risk management to medical devices,” has been released and is now available from Document Center Inc.   It is the UK implementation of EN ISO 14971:2012. It is identical to ISO 14971:2007 (Corrected Version from 10/2007).  FYI: The 2012 Edition supersedes BS EN ISO 14971:2009 which is withdrawn.

This new edition provides the user with important new information on the differences between the ISO 14971 and the requirements of the 93/42/eec, 90/385/eec and 98/79/ec Directives.  In other words, Annexes ZA, ZB and ZC explain to which requirements, under which conditions and to what extent presumption of conformity can be claimed.

This is the first time that I recall seeing such a clear and detailed explanation of differences between the standard and the directive in the EN Annexes that are now appearing at the head of many of the ISO adoptions.  Here, for each directive referenced by Annex, there are about 7 areas with differing requirements.  Furthermore, information on corrective action is also given.

Here is an example of the new guidance provided:

“1. Treatment of negligible risks:
a) According to standard ISO 14971, the manufacturer may discard negligible risks.
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 2 of Annex I to Directive 93/42/EEC.”

As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO 14971 is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.

All BS EN standards are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our expert staff can assist you in all your regulatory documentation requirements.

 

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics.  We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.”  Note the English spelling for labeling.  All ISO standards are published using the English spelling, not the American.  The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008.  So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to answer any questions you may have about these publications.

Document Center’s Top 20 Best Selling Standards for 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011!  Here’s what Document Center customers wanted this year:

  1. ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
  2. ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
  3. AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
  4. 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
  5. BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
  6. ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
  7. IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
  8. AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
  9. ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
  10. ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
  11. ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
  12. ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
  13. ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
  14. SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
  15. ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
  16. ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
  17. BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
  18. ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
  19. ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
  20. ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  We’re happy to help you with all your standards questions and requirements.

Happy New Year!

There’s a new standard EP23 available for Laboratory Quality Control Based on Risk Management

CLSI has released a new standard, EP23, titled “Laboratory Quality Control Based on Risk Management; Approved Guideline.”  The document, available through Document Center Inc., provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

CLSI, formerly known as NCCLS, is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.

The new guideline EP23 compliments the ISO 14971, “Medical devices — Application of risk management to medical devices,” ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” and ISO 20993, “Biological evaluation of medical devices — Guidance on a risk-management process.”  It shows the increasing emphasis on risk management as a component of quality control in the health care industry.

All standards mentioned can be purchased from Document Center Inc. through our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you in the challenge of compiling and maintaining your standards documentation.

New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011.  The document is titled “Medical devices. Application of risk management to medical devices.”  It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify.  For example, the Corrigendum 1 for  the BS EN ISO 14971:2009 corrects the pagination of the document.  So, there is no page within the document that describes the change.  It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard.  The BS EN ISO 14971 is the official English language edition.  It continues to adopt the ISO-14971:2007 Edition.

The standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc.  Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617.  We’re happy to help you with all your Standards Requirements.