ISO 17664 Updated – Medical Device Sterilization Instructions

ISO 17664 has just been updated.  The new title of this 2nd Edition is Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices.  Previously, it focused on Sterilization of medical devices so you can see the scope of the standard has been expanded.  The 1st Edition from 2004 is now obsolete.  You’ll need to be using this new update and you can get it now from Document Center Inc.

ISO 17664 provides manufacturers with requirements for the instructions that accompany their medical devices and other health care products.  These instructions center on the processing required to make these products ready for use.  This may include an initial sterilization or other processing.  Or it may be processing needed for the reuse of the product.

This update of the ISO 17664 was generated by technical advances in sterilization technologies.  With products becoming more complex, the techniques to clean them are coming under greater scrutiny.  Comprehensive instructions on processing utilizing available equipment is essential.  Additionally there may be critical requirements during the inspection and testing phase performed after a device is cleansed.

As noted, the 32-page 2nd Edition cancels and replaces the 1st Edition.  It is a technical revision, with an expanded scope.  Now the standard covers devices that need both sterilization (as before) and/or disinfection (added) prior to use.

Document Center Inc. customers have already been notified that the new Edition has been released.  We’re filling orders placed at our webstore, www.document-center.com, now.  Here’s a direct link to the order page for ISO-17664:2017 for your convenience.  It’s available in paper format and for pdf download.

All ISO standards are also available as part of our Standards Online cloud access service.  This allows you to set up a subscription for the standards critical to your business in a company-wide environment.  To learn more, check in with us by phone (650-591-7600) or email (info@document-center.com). We have been working with standards since 1982 and offer a wide range of products to support your compliance requirements.  Make us your Standards Experts!

NFPA 101 2018 – Life Safety Code

The Life Safety Code, NFPA 101, has just been updated and the new 2018 Edition is available from Document Center Inc. now.  You can purchase your copy either in softcopy format or for pdf download.  This is one of the most important Codes that NFPA produces.  It provides requirements for occupant fire safety throughout the life of a building.  The new 2018 Edition contains major changes and an expanded scope.

What are the areas the NFPA 101 addresses?  Egress, sprinklers, alarms, emergency lighting, smoke barriers, special hazard protection and other concerns are all included in this Code.  So it is appropriate for use both by architects and engineers during the design phase and by building owners and managers during the occupancy phase.  Other facilities professionals like hospital administrators should also use this standard.

The new Code has been expanded to include  hazardous materials emergencies, injuries from falls, and emergency communications.  It continues to be applicable in situations where new materials are being used.  And it can be adapted for buildings that are being used in non-traditional ways.

NFPA has noted the following major changes for the 2018 NFPA 101:

  • New requirements for hazardous materials protection of other than fire-related hazards (Chapter 8)
  • A new reference to NFPA 4 for integrated fire protection and life safety system testing, and new provisions for risk analyses for mass notification systems (Chapter 9)
  • Animal housing facilities added as special structures (Chapter 11)
  • Added requirements for carbon-monoxide detection in new assembly occupancies and new residential board and care occupancies (Chapters 12 and 32)
  • Added criteria for door locking to prevent unwanted entry in educational, day care, and business occupancies (Chapters 14-17, 38, and 39)
  • A mandatory sprinkler requirement for all but very small new educational occupancies (Chapter 14)
  • New provisions that permit health care and ambulatory health care smoke compartments up to 40,000 ft2 (3720 m2) in area (Chapters 18 and 19)
  • Added requirements for bathtub and shower grab bars, which are then referenced by numerous occupancy chapters (Chapter 24)
  • Added requirements for attic protection requirements that impact certain new hotels and dormitories and apartment buildings (Chapters 28 and 30)
  • A new reference to NFPA 99 for medical gases in business occupancies (Chapters 38 and 39)
  • A new Annex C that offers guidance on several NFPA hazardous materials standards to assist users with the new hazardous materials protection requirements

If you use the NFPA 101, you’ll want this new edition now.  Purchase your copy from Document Center Inc., an authorized distributor of the NFPA standards.  You can search for and order them at our webstore:  www.document-center.com.  Here is a link to the order page for the NFPA 101 for your convenience.

All purchases include our “best-in-class” notification service at no additional charge.  Because this Code is updated on a three-year cycle, you’ll be informed in 2021 when the next edition is issued.  Other Document Center services including reporting and monitoring, perfect for organizations with compliance requirements.  To learn more, just get in contact with us.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Make us your Standards Experts!

ANSI Standards Simulation Contest

ANSI’s 2nd Standards Simulation Contest will be taking place tomorrow and I will be mentoring one of the teams.  The contest is sponsored by John Deere and is held under the auspices of the ANSI (American National Standards Institute) Committee on Education (COE).  It’s a training activity for university students to support standards and standardization education.

The contest focuses on two skill sets.  The first is the ability to define the performance and other requirements for a sample standard.   This year’s competition is unusual in that the “standard” the students will be developing will contain minimal text.  This means that it will be composed almost entirely of graphical elements.  Luckily, the subject of this year’s standard is vehicle-to-vehicle communication.  So the use of icons and other graphical elements should make for interesting presentations!

Next, the students will have to try to persuade other teams to support their unique requirements.  Each team represents a different user profile (manufacturer, government player, technology company, and so on).  And there will be two competing technologies that are incompatible.   Negotiating and people skills will come to the forefront during this portion of the competition.

In the last part of the Standards Similation, the teams will attempt to gain consensus in the final negotiations.  For all of us in the standards business, this is really fast-track!  Industry experts from the ANSI membership will choose the winning team.  Judging criteria are based both on the proposed standard each team develops and on their leadership and negotiating skills in achieving their assigned objectives.

The standards community has been focused on fostering greater awareness of standards in the world at large and on more exposure to standards and standardization in educational settings.  The ANSI Committee on Education is at the forefront of this effort.  You’ll find more information on them on their ANSI COE homepage.

As an additional note, San Jose State University (SJSU) is right in Document Center’s backyard.  Representatives of the institution have been particularly active in the COE and other ANSI activities.  In fact, Tiana Ashley Khong, an SJSU student, was the winner of this year’s World Standards Day Student Paper competition with her “The World in 2050: Safety by Design.”  Congratulations to the faculty and students of SJSU for their participation in these standardization events.  I’m looking forward to tomorrow’s event!

MIL-STD-1791 C Fixed Wing Aircraft Cargo Requirements

MIL-STD-1791 has just been updated.  The new Revision C is titled Designing for Internal Aerial Delivery in Fixed Wing Aircraft.  The standard actually addresses design and performance requirement for items that are transported on board USAF (U.S. Air Force) fixed wing cargo aircraft.  This is a 397-page interface standard and is available now from Document Center Inc.

The standard begins with the usual scope, referenced documents and definitions sections.  The main body of the core text covers both general requirements and detailed requirements.  A fairly lengthy notes section is also included.

However, the bulk of the MIL-STD-1791 is to be found in the two Appendices.  Appendix A covers supplemental airlift concepts and procedures.  Appendix B is on aircraft data.  Both are arranged in the usual format, with scope and definitions sections preceding the body of each.

Changes are extensive.  You may find some black lines in the margins.  However, use the “Summary of Change Modifications” starting on page iii for complete information.  Many paragraphs have been added throughout the standard.  Figures have been modified.  Tables have been changed.

In the main, traditional cargo requirements are included in this publication.  In some instances, equipment carried on these cargo aircraft includes personnel — like patient care equipment or what are called seat pallets.  The MIL-STD-1791 provides you with additional resources, but addresses many of the requirements for those situations.

Document Center Inc. has been providing government specs and standards to industry since 1982.  We have an extensive collection of both current and obsolete Mil-Specs and Standards.  You can search for and order them at our webstore, www.document-center.com.  Here is a direct link to the order page for MIL-STD-1791 for your convenience.

Many of these publications are widely available.  However, good document control practices mean that notification of changes and update availability is critical.  Document Center’s “best in class” notification service comes free with your document purchase.  We have many additional support services for compliance requirements.

If you need assistance, just get in touch with us.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Learn why so many government contractors make us their Standards Experts!

NFPA 10 Updated – Portable Fire Extinguishers

NFPA 10, the Standard for Portable Fire Extinguishers, has just been updated.  The new 2018 Edition is available now from Document Center Inc. in both paper format and for pdf download.  It replaces the previous 2013 Edition which is now obsolete.

The first NFPA standard on this topic was published in 1921.  Over the years, the publication has seen a number of changes.  However, it remains the primary standard for portable fire extinguishers in the U.S.

It provides the minimum requirements for the selection, installation, inspection, maintenance, recharging and testing of both portable fire extinguishers and also Class D extinguishing agents.  Please note:  You may need to meet additional NFPA requirements for some specific occupancies.

The 2018 Edition has clarifications on a number of topics.  These include:

  • Electric monitoring,
  • Obsolete extinguishers,
  • Installation of extinguishers in areas with oxidizers,
  • extinguishers signs and mounting equipment (including cabinets)

Additionally there are new requirements for maintenance of hose stations, marking of Class AC and AK extinguishers, and updated Annexes reflecting current extinguisher types and ratings.

The NFPA 10 remains organized into 8 Chapters, beginning with the usual administrative, referenced documents, and definition sections.  The remainder of the chapters cover general requirements, selection, installation, maintenance (including inspection and recharging), and hydrostatic testing.  There are an additional 11 Annexes and an Index in this 77-page standard.

You’ll want to purchase a copy from an authorized distributor like Document Center Inc.  You can search for and order the NFPA standards at our webstore, www.document-center.com.  Here is a direct link to the order page for NFPA 10 for your convenience.

Document Center Inc. has been working with standards since 1982.  We have a wide range of additional services to support your use of standards.  To learn more about how we can help your organization, contact us by phone (650-591-7600) or email (info@document-center.com).  Learn why so many organizations make us their Standards Experts!

BS PAS 17271 – Fraud Protection

BS PAS 17271 on protecting consumers from financial fraud has just been released.  The title of this publication is Protecting customers from financial harm as a result of fraud or financial abuse. Code of practice.  It is one of the series of Publicly Available Standards published by BSI and available from Document Center Inc.

This new PAS is interesting in a number of ways.  Although it has been specifically developed for the UK stakeholders, it certainly can be applied anywhere on the globe.  It represents the current move to standardize areas that are not part of the usual engineering focus addressed by standards in the past.  And it shows how industry sectors can rely on standardization to help solve a wide range of public safety concerns.

FYI:  BS PAS 17271 is not a requirement for non-UK organizations.  It is intended for use by British firms managing the money or other financial assets of UK consumers.  This could include banks, credit unions, pension managers, and so on.

The BS PAS 17271 covers three main areas where good practices can make a difference.  These are:

  • Recommendations for protecting customers from financial harm that might occur as a result of fraud or financial abuse
  • Guidance on spotting at risk customers, assessing the potential risks to them  and actions to take to prevent or minimize financial harm
  • Guidance on supporting customers, inluding minimizing future risks, in cases where fraud or financial abuse has already occurred

You’ll be pleased to know the document includes detailed recommendations, guidance and a comprehensive checklist for organizations implementing best practices in this area.

Document Center Inc. is an authorized distributor of BSI standards, so you can order at our webstore www.document-center.com with confidence.  Here is a direct link to the order page for the new BS PAS 17271 for your convenience.

Your purchase will come with our “best in class” notification service included inn the price.  Additional compliance support services are also available from us. Get in touch with our staff by phone (650-591-7600) or email (info@document-center.com) to discuss a conformance solution that is tailored for your organization’s specific needs.  After all, we’re your Standards Experts!

IEEE 1012 2016 Update for V&V

IEEE 1012 2016 Edition has just been published.  This new update is a revision of the 2012 Edition and it’s Corrigendum 1 (correction sheet).  The standard is titled Standard for System, Software, and Hardware Verification and Validation.  It helps organizations determine if their products meet the intended use (user needs).

Verification and validation (V&V) processes can be used for systems, software and hardware.  Even interfaces are included in V&V scopes.  It’s used throughout the product lifecycle, a tool for building and maintaining quality in a product or system.  You’ll use objective tools to assess, analyze, evaluate, review, inspect and test products and processes.  It’s an on-going process intended to be used during your product lifecycles, not afterwards.

The 260-page IEEE 1012 provides requirements in terms of activities and tasks to use for V&V.  It begins with the usual scope, referenced documents, and definitions sections.  It then moves on to the relationships between V&V and lifecycle processes.  Clause 5 shows you how to use integrity levels to determine the scope of your V&V processes.  Next you’ll get an overview of the V&V process and testing.  Details follow in Clause 7.

Sections 8, 9, and 10 cover V&V processes for systems, software and hardware respectively.  Clause 11 is on the various reports and other documentation requirements.  And finally, Clause 12 reviews the V&V plan.  13 Annexes then follow.  These are all informative, covering a wide array of issues.  The last is a 22-item bibliography.

IEEE standards are available in a variety of formats.  Choose an authorized IEEE distributor like Document Center Inc. for your purchase.  You can search for these standards at our webstore, www.document-center.com.  Here is a direct link to the order page for the IEEE 1012 in paper format and for the IEEE 1012 pdf download.

IEEE standards can also be included in our Standards Online enterprise cloud-based access solution.  This allows you to set up a custom collection of standards for your entire organization to access as needed.  To learn more about your options, please get in touch.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Remember, we’ve been working with standards since 1982.  Make us your Standards Experts!

IPC 6012 D Amendment

IPC 6012 Revision D has just been amended.  This is the Qualification and Performance Specification for Rigid Printed Boards so important to the electronics industry.  The new IPC 6012 D Amendment 1 is available now from Document Center Inc.  Currently it is only available in pdf format (single user download and site license).  It updates the IPC 6012 D that I reviewed back in 2015.

The IPC 6012 D Amendment makes changes to the existing acceptance criteria for copper wrap plating measurements.  These changes will be valid moving forward (that is, after January 1, 2018).  So your legacy designs will not be impacted.  The new dual criterion for Class 3 copper wrap plating is for newer designs only.

The balance of the Revision D remains stable.  You’ll continue to use this standard for the qualification and performance of rigid printed boards.  This includes such topics as final finish and surface plating requirements, conductors, holes (vias), frequency of acceptance test and quality conformance.  Electrical, mechanical and environmental requirements are also included.

To get your copy of the new amendment, go to the Document Center Inc. webstore at www.document-center.com.  The new publication is featured in our trending documents section.  Here is a link directly to the order page for the IPC 6012 D Amendment 1 for your convenience.

As an authorized distributor of the IPC standards, Document Center Inc. is able to provide you with access to the documents in paper and pdf format.  You can also buy site licensing from us as well.  You’ll notice that the CD Rom format is no longer available for most IPC standards, making the old “kit” option obsolete as well.

Benefits of using Document Center include our “best in class” notification service free with your standards purchase, access to our knowledgeable staff for support with those pesky standards questions, and more.  To learn about the wide range of products and services available, just reach out to us by phone (650-591-7600) or email (info@document-center.com).  You can even get a quote for moving your standards collection to our Standards Online cloud subscription service.

Find out why so many companies make Document Center their Standards Experts!

 

ISO/IEC 19988 Core Business Vocabulary Standard Updated

ISO/IEC 19988, the Core Business Vocabulary Standard, has just been updated.  It is the definition document underlying the use of EPCIS for trading partner information exchange.  The new 2nd Edition available now from Document Center Inc.  It replaces the previous 1st Edition from 2015 and is a technical revision.

The ISO/IEC 19988 is the international adoption of the GS1 CBV Core Business Vocabulary Standard.  The 2nd Edition is identical to the CBV Version 1.2 from September 2016.  Changes include the following:

  • New terms for EPCIS error declaration reason identifiers
  • Requirements for the URI structure for EPCIS event identifiers
  • New business step values dispensing and voidShipping
  • New disposition values dispensed and partially_dispensed
  • A new section for trade item master data attributes
  • Expansion of the section on location and party master data attributes

At this point, if you’re not familiar with this standard you’re probably wonder what the heck it’s all about!  EPCIS is a standard used to share trading partner information as products move through the supply chain.  CBV is the definitions document used for common implementation of EPCIS.

These standards underline the increasing reliance on trading partner relationships in order to produce and distribute goods as the global economy takes off.  The need for consumer and regulatory information throughout the product lifecycle is helping to fuel the development of these standards.  And traceability remains a critical issue, as seen in the recent disclosure of sub-standard material shipments of aluminum recently.

You’ll need a copy of this new revision and you’ll want to use an authorized ISO/IEC distributor like Document Center Inc.  Use our web store to place your order at www.document-center.com.  Here is a direct link to the order page for  ISO/IEC 19988 for your convenience.

Many of you need visibility of your standards collection throughout your organization.  We suggest using our Standards Online cloud access service.  It provides your entire organization with a way to use the latest editions of the documents critical to your success.  Contact us by phone (650-591-7600) or email (info@document-center.com) to learn more.  Find out why so many companies make us their Standards Experts!

ISO 13485 Handbook Released

ISO has just published an ISO 13485 handbook and it’s available now from Document Center Inc.  This new guidance document is titled ISO 13485:2016 – Medical devices – A practical guide.  It was developed by members of the committee to assist you in implementing this important quality standard.  It contains their best advise for success!

ISO 13485 Medical Devices – A Practical Guide addresses the challenges faced by those of you in the medical device industry using the ISO 13485.  This is the requirements document for regulatory Quality Management Systems (QMS).  The handbook is therefore divided into mirror sections for the structure of the ISO 13485.  And, like many other guidance documents, each comments area is prefaced by the actual text of the 13485 standard.

As you move through the handbook, you’ll find an ISO 13485 clause, a paragraph on the intent of the clause, and then the guidance.  Whenever possible, actual examples are used.  So for the 13485 clause on human resources, there is discussion on the processes you’ll need to identify training needs.  And for this, an example of a professional extrusion specialist’s need for additional training is given.  After all, the improper operation of an extrusion machine might negatively affect your medical devices’ safety and performance.

This ISO 13485 Handbook is 220 pages of detailed information on using the ISO 13485:2016 Edition.  This will prove to be an invaluable tool for industry, as implementation of the ISO medical device standards has been impacted by recent changes in the documents themselves.

You’ll want to get your copies from an authorized ISO distributor like Document Center Inc.  Just order at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 13485 Medical Devices – A Practical Guide for your convenience.  And you can find the order page for the ISO 13485 here.

When picking a format for using the ISO standards, you have a number of choices with Document Center Inc.  Of course, we have the usual paper copy and pdf download options.  But your organization may prefer cloud access.  You can talk with our staff about our Standards Online subscription services.  Many of our medical device customers find this an excellent solution to the stringent document control requirements for regulatory certification.

Learn more by reaching out to us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982 and recognize the needs that standards users have beyond just purchasing documents.  Our services range from reporting to notifying to delivery and maintenance of your compliance documents.  Make us your Standards Experts!