New ISO 14046 Environmental Management of Water ‘Footprint’

August 8th, 2014

Water.  We need it, but it’s a challenge if there’s not enough, or too much, or if it’s not usable!  For organizations, managing one’s impact on the environment requires monitoring of water usage by staff and facilities.  And of course, there’s a further consideration of the impact your processes may have on the public water supply and environment at large.  Now there’s a new standard in the ISO 14000 series that helps you assess your situation.  It’s the ISO 14046, “Environmental management – Water footprint – Principles, requirements and guidelines.”

Just released by ISO, the new document provides you with the tools you’ll need to set up a water footprint assessment.  You’ll use this to insure that your data collection processes are consistent, transparent, and reproducible.  This assessment will provide you with the information you need to identify potential environmental impacts, which means that you can confidently manage your water usage and environmental risks.

The standard can be used specifically for a water footprint assessment, or as part of a wider assessment of environmental impacts and life cycle concerns.  It will give you a broad understanding of the terminology used to describe various types and classifications of water,  as well as the concepts for these types of assessments and the data they generate.

Primary clauses of the new document include Principles, Methodology, Reporting and Critical Review.   There’s also an Annex A, which provides you with a general guideline and some additional requirements you may want to consider.   A bibliography with 12 additional references finishes up the document.

If you’re concerned about the risks that your organization may face regarding water usage and sources of pollution, you definitely need to take a look at the ISO 14046.  You can get your copy from Document Center Inc. in either paper format or for pdf download.  Just order at the Document Center webstore at www.document-center.com.  Or consider setting up a Standards Online subscription access account for your company.  All ISO standards can be included in this service.

Our staff will be happy to help you with all your standardization questions and requirements.  Contact them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New FDA Guidance for In Vitro Companion Diagnostic Devices

August 7th, 2014

For some medical devices and/or therapies, the use of in vitro companion tests or devices (aka IVDs) is an essential part of the product.  Now the FDA is providing you with information on how it expects to be informed of such devices.  This new FDA Guidance Document, “In Vitro Companion Diagnostic Devices,” provides you with general information on definitions, rationale for oversight, and other policy information you’ll need to know.

Why now?  The use of increasingly personalized therapies is dependent on identification of patient populations that will either be helped or harmed by such targeted treatments.  (The Guidance Document gives HER2 breast cancer screening as an example.)  An additional use of such products or processes is in monitoring the effectiveness of treatment as well.

What’s so special?  These diagnostic companion devices may receive special treatment, since they can go through the FDA approval process both in tandem with the therapeutic product itself or alone, both prior to and post approval of the therapeutic product they’re used with.  Additionally, the diagnostic companion may have originally been intended for another use and only now is being re-purposed.

The FDA will use a risk-based approach to determine the regulatory pathway for IVD companion diagnostic devices.  So you’ll need to apply for FDA approval and go through the same processes used for other devices.  And yes, there will be labeling and other requirements as well.  This guidance document gives you an overview of what to expect, how to proceed, and what to prepare for.

The FDA provides the public with a number of these guidance documents and Document Center Inc. tracks them for you.  For example, a draft of this document was released in 2011.  For our customers who use this draft, notification of the new edition has already taken place.  This is an invaluable service, since there are few ways to monitor these FDA publications.

If you’d like to get the superior services offered by Document Center, order your standards at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing customers with standards and supporting services since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New ISO 16443 Dentistry Vocabulary Standard

August 6th, 2014

Vocabulary standards are a kind of background document that is actually essential to good standardization practice.  Now the work on the vocabulary for dentistry established by ISO 1942 (Dentistry – Vocabulary) has been expanded with the release of the new ISO 16443.  This new standard, titled “Dentistry – Vocabulary for dental implants systems and related procedure,” not only adds to the set of terms defined for dental standardization but also corrects some definitions of the earlier document.

The new ISO 16443 covers terms for both dental implants themselves and for the instruments and accessories used for the implants and procedures.  You’ll want to be aware that there are certain areas that could be considered dental implants that are specifically excluded.  These include grafting materials and membranes.  And they exclude implantable devices intended as anchors for facial reconstruction or for an orthodontic appliance.

This means your definitions will cover dental prosthesis terms only.  That leaves a lot of territory to cover, from root canal work to a wide variety of systems to supporting the process of generating a dental prosthesis to tools used for these processes and procedures.

While I’m being challenged by writing about dentistry first thing in the morning (I can practically hear the drill now!), the fact of the matter is that dentistry has made tremendous improvements in implants over the years.  This new standard provides developers, manufacturers and users of these products with a level playing field for defining the products and processed used in this area.

If your company is involved in dentistry and dental implants, you’ll want to get your copy of this new standard.  You can order online at the Document Center webstore (www.document-center.com).  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to get your copy in paper format, for pdf download, or as part of our Standards Online subscription access service for multi-user licensing.

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New ISO Guide 80 – Quality Control Reference Material

August 5th, 2014

One area where the use of standards is long-standing is in metrology, the science of measurement.  And one standard practice is the use of reference materials as part of various test procedures.  You may think of this as quality control samples or check samples.  Now there’s a new ISO Guide 80, “Guidance for the in-house preparation of quality control materials (QCMs).”  It will help you understand the characteristics of various reference materials used for quality control.  And it describes the processes your staff will use to prepare such material, as well as key considerations for setting up your system.

QCM’s are used to provide laboratories with a way of regularly checking routine test procedures for precision.  They’re valuable in the preparation of QC charts, verifying the stability of a process or test.  They can be used when developing a process, to establish consistency.  Or they might be used to compare results using two types of similar tests.  Of course, they can be used to measure variations in the environment and for instrument performance checks.  And they are valuable for reproducibility studies.

Your ISO Guide 80 has 12 document-specific clauses, covering the following areas:

  • Quality control materials themselves
  • Applications of QCMs
  • Steps for the in-house preparation of QCMs
  • Material specification
  • QCM preparation itself
  • Homogeneity
  • Characterization and value assignment
  • Stability
  • Transportation
  • Documentation
  • Storage
  • Usage

There are six Annexes that cover specific case studies to provide examples of the use of this guide.  A bibliography with 33 references finishes up the document.

You’ll see applications for this guide for processes as diverse as testing drinking water to the evaluation of raw materials for pharmaceuticals to verifying the grade of a commodity.  You’ll find it to be a companion for the ISO Guide 34 and ISO Guide 35, both of which provide information on reference materials.

In order to get your copy, you’ll want to use an authorized distributor of ISO standards and Document Center Inc. is such a source.  You’ll go to our webstore at www.document-center.com and order the standards you need in either paper format or for pdf download.  Or you can check with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can even help you set up your own custom collection for online access using our Standards Online portal.  We’ve been providing customers like you with standards and standards services since 1982.  Make us your Standards Experts!

New ISO 10002 2nd Edition – Customer Satisfaction

August 4th, 2014

Quality management standards now address a range of issues that affect a broad spectrum of organizations.  One of the most interesting is the ISO 10001 series on Quality Management for Customer Satisfaction.  ISO 10002, “Quality management — Customer satisfaction — Guidelines for complaints handling in organizations,” was the first of the series to be released, back in 2004.  Now that standard has been updated and the 2nd edition is available from Document Center Inc.  It cancels and replaces the 1st Edition from 2004 along with the technical corrigendum (correction sheet) from 2009.

This update primarily takes into account the balance of the series, all of which were released after the initial publication of the ISO 10002.  So you’ll not find a great deal of change in the basic structure of the standard.  However, the other 3 standards in the series are now referenced throughout the document.

Here’s the list of the other standards that comprise this collection:

  • ISO 10001, Quality management – Customer satisfaction – Guidelines for codes of conduct for organizations
  • ISO 10003, Quality management – Customer satisfaction – Guidelines for dispute resolution external to organizations
  • ISO 10004, Quality management – Customer satisfaction – Guidelines for monitoring and measuring

ISO 10008, “Quality management – Customer satisfaction – Guidelines for business-to-consumer electronic commerce transactions,” could also be considered part of the series but is not referenced in the ISO 10002.

How are these “new” publications integrated into the 2nd edition of the ISO 10002?  Let’s take an example, the flowchart for escalation in Annex F.  This chart is still in the same format as in the 1st edition.  However, in the 3rd column for external resolution, instead of just saying “external resolution,” the document now says “external resolution base on ISO 10003.”

If you use the document in your business, you’re going to need a copy of the new edition.  You can order online at the Document Center webstore (www.document-center.com).  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  This is a copyright document, so you’ll want to get a copy from an authorized source.  Document Center has been a dealer of ISO standards since the 1990′s.

Find out why so many customers make Document Center their first stop for technical information.  Make us your Standards Experts!

New ISO/IEC TR 29144 – Commercial use of Biometrics

August 1st, 2014

Biometrics is a technology on the way to remaking how people are identified.  So the release of the new Technical Report, ISO/IEC TR 29144, “Information technology – Biometrics – The use of biometric technology in commercial Identity Management applications and processes,” is well-timed.  The document is intended to be an overview of the concepts and considerations you’ll use when implementing an Identity Management Solution using biometrics.

As an overview document, the goals of the authoring committee are fairly straight-forward.  The intention is that

  • the technical report supports smoother introduction and operation of biometric identification systems, including improved public perception and understanding.
  • the document will aid in the reduction of long-term costs.
  • commonly approved good privacy practices will be promoted.
  • improved interoperability can be achieved, including at the international level.
  • vendor independence will take place for implemented solutions.

It’s a companion document to the ISO/IEC 24760-1, “Information technology – Security techniques – A framework for identity management – Part 1: Terminology and concepts.”  You’ll use the 29144 technical report in order to implement a biometric solution for the identity management system defined in the 24760-1 standard.   To help you get started, the document covers three main areas:  Biometrics and Identity Management Systems, Considerations for the same, and Implementation issues.

There are a number of standards that support the underlying technology and information exchange required to support this type of identification.  So that aspect of standardization is fairly well documented.  However, this new Technical Report is more concerned with the nuts and bolts of the system those technologies will support.  So you’ll get a good understanding of how all the pieces (technical, legal, security, privacy, integrity and so on) fit together.

If you need any of the ISO and ISO/IEC standards on this topic, you can go to the Document Center webstore at www.document-center.com and order online.  Unsure of which documents you might need?  Go to our Document Center List of Standards on Character Sets and Information Coding.  You’ll find a large number of standards on this page, so use the find function (control f) on your keyboard and search for “biometric.”  This will give you 115 standards that have a title that includes your topic!

Of course, you may prefer to have our staff give you a helping hand in identifying the standards you need, or to confirm that the standards you have are current.  Just contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff will be able to assist you right away with many of your standards questions and issues.  Make us your Standards Experts!

New Revision for AAMI TIR37, Health care product sterilization

July 31st, 2014

AAMI has just released a new edition of AAMI TIR37, “Sterilization of health care products – Radiation – Guidance on sterilization of biologics and tissue-based products.”  This document is numbered TIR37:2013 even though it’s just been released this month.  It supports the use of the ISO 11137 series on the sterilization of health care products using radiation.  You can purchase your copy from Document Center Inc. in paper format or for pdf download.  It is also available as part of our Standards Online internet access service.

As you might guess, there are unique issues for the sterilization of biologics and tissues.  This Technical Information Report provides guidance on every aspect of validation, routine processing, and the maintenance of the sterilization process.

If you already use this document, you’ll want to know where the changes are.  Here’s a brief synopsis of the updates:

  • The scope of the standard has been expanded from human tissue-based products to “biologics and tissue-based products,” to allow for expansion of the principles of the report to other types of tissues other than human.
  • There’s more information for selecting a dose establishment method.  This is included in a new Annex A, to help you select processes suitable for your biologic or tissue-based product.
  • The information on SIP (sample item portion) use in dose establishment has been expanded.  The document notes that SIP use is not really recommended for these types of products, but it still provides you with information on what needs to be addressed should you cho0se this method anyway.
  • There’s a new clause (4.4.4) on how to adopt a new product into an existing product “family.”
  • More information on MPN (most probable number) testing has been added. This is a great way to get a more sensitive bioburden test with lower bioburden levels, meaning that lower sterilization doses can be established.
  • Section 5.5.2 has been renumbered 5.6.2 and information on loading patterns for irradiation has been added.  You’ll also get guidance on using a different container for shipment versus irradiation.

You’ll also want to note that the information in AAMI TIR37 does not address inactivating viruses and prions.  You’ll use ISO 22442-3 (ANSI/AAMI/ISO 22442-3) for that.

The whole issue of the sterilization of health care products is being tested by the expansion of the products into the use of tissues and the increasing challenges of maintaining the sterile condition as products are introduced into patients.  It is incumbent upon every manufacturer and health care facility to take the utmost care in this regards.  And the increased standardization activity in this area shows how important this issue is to consumers and industry.

For the standards you need, use the Document Center webstore at www.document-center.com for your purchases.  You’ll be amazed at the many tools available to our customers, both on the website (accessed by registration) and as additional services.  For more information on how Document Center can help you collect and maintain the standards you need, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make us your Standards Experts!

New AS 6174 Revision A – Counterfeit Material

July 30th, 2014

Well, it’s been a big month for standards on spotting and eliminating counterfeit material and components from the supply chain, and yep!  Here’s another one!  AS 6174, “Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel,” has just been revised.  The new Revision A is available from Document Center Inc. in both paper format and for pdf download.  It cancels and replaces the original release from 2013.

This Aerospace Standard provides you with a methodology to maximize the availability of authentic material, including procuring material from reliable sources.  It discusses methods like certification, traceability, testing and inspection which assure authenticity and conformance of material in your supply chain.   It shows you how to control material that you’ve identified as fraudulent or counterfeit.  And it provides guidance on how to report such material to other users and to the authorities.

The new Revision A has been generated because a significant error in the standard’s material traceability requirement was discovered.  This edition corrects that problem by updating sections 3.1.2.c, 3.1.2.f, and 3.1.6.  It also establishes precedence and provision for use of slash sheet documents.

If you need a copy of this new AS 6174 A, you can order your copy at Document Center’s webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  If you’ve had difficulties in the past with downloading the authorized copies of SAE standards like this one, you’ll be pleased to know that the DRM plugin from FileOpen is no longer being used.  So if you need a pdf copy, you’ll be able to purchase and use it easily.

Document Center Inc. has been working hard since 1982 to help you identify and use the standards that affect your business.  We have a wide range of services that compliment the sale of standards on our site.  Make us your Standards Experts!

New IEC/TS 62668 Parts 1 and 2 – Counterfeit Prevention

July 29th, 2014

Preventing the introduction of counterfeit components into the supply chain is an important issue for the avionics industry.  Supporting this effort, the IEC/TS 62668 series provides the technical specifications needed.  And the basic precepts of the documents can be used in other industries as well.  This month the IEC/TS 62668-1 2nd Edition has been released and IEC/TS 62668-2 1st Edition has been issued.  We’ll review them one at a time.

IEC/TS 62668-1, Edition 2.0, Process management for avionics – Counterfeit prevention – Part 1: Avoiding the use of counterfeit, fraudulent and recycled electronic components

If you’re in the aerospace, defense or high performance industries, you’ll use this part of the series for defining the requirements necessary for avoiding the use of counterfeits.  It provides requirements for protecting intellectual property (IP), which can be compromised by fraudulent products and services.

Areas covered by the standard include an overview of counterfeiting and the issues raised by the introduction of counterfeits and fraudulent parts into the supply chain.  It provides best practices guidance, as well as information on the various certification schemes developed to provide confidence in purchasing processes.  The Annexes are particularly helpful, covering contacts from industry and government, examples of aftermarket sources, an example of a RECS (Reliable Electronic Component Suppler) certificate, and a flowchart of the specification’s requirements.

Of course, this 2nd Edition cancels and replaces the first edition from 2012.  It is a technical revision.  Changes include updating the concepts of fraudulent component, recycled component and suspect components.   Counterfeit awareness training has been added as a requirement and the Annexes have been updated with new information for references and web links.

IEC/TS 62668-2, Edition 1.0, Process management for avionics – Counterfeit prevention – Part 2: Managing electronic components from non-franchised sources

This companion specification has been released with requirements when components are purchased outside of the usual franchised distributor network.  It notes that it is preferable to go through trusted channels when purchasing components, but offers guidance when that is not possible.

Of course, the goal is to use an OEM (Original Equipment Manufacturer) that meets the requirements of IEC/TS 62668-1 above.  However, verification to insure protection against the risks associated with purchasing from non-trusted suppliers is essential.

The specification provides you with an overview of the risks involved, and the process used (derogation) when purchasing through the usual channels is not possible.  The Annexes provide you with the IEC/TS 62668-1 flowchart, an example of a detailed tests list (linked with procurement risks levels) and iNEMI counterfeit calculator tools.  The bibliography contains over 2 pages of references for further review.

You’ll want copies of these new IEC/TS 62668 editions and you can purchase them from Document Center Inc.  Use our webstore at www.document-center.com or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to order IEC standards in paper format or for pdf download.  And you can even include them in your Standards Online subscription for online access throughout your organization!

Remember, Document Center Inc. has been providing standards to folks like you since 1982.  We’re a trusted resource for compliance information and support services to maintain standards collections.  Make us your Standards Experts!

Amendments update ISO 11607 series

July 28th, 2014

The ISO 11607 series, “Packaging for Terminally Sterilized Medical Devices,” has just been updated with the release of amendments for each of the 2 parts.  You’ll need the new updates in order to keep your copies of the standards current.  Let’s review each amendment separately:

ISO 11607-1, 1st Edition, AMENDMENT 1, Part 1: Requirements for materials, sterile barrier systems and packaging systems, Packaging for terminally sterilized medical devices

This is the lengthier amendment, a total of sixteen pages in all.  It includes two pages of pen and ink changes that you’ll need to make to your original copy of the 2006 edition.  Next the list of test methods given in Annex B Clause 2 (B.2) is replaced by a brand new Table B.1, Test Methods and Their Status.  This new table is seven and a half pages in length!  Lastly, extensive changes are made to the bibliography.   This new amendment will keep you busy making changes and analyzing the impact.

ISO 11607-2, 1st Edition, AMENDMENT 1, Part 2: Validation requirements for forming, sealing and assembly processes, Packaging for terminally sterilized medical devices

This amendment is going to be a little easier for those of you using the document.  It primarily focuses on updating the bibliography.  This means you’ll be reviewing your referenced documentation to make sure you’re using the correct editions of a number of standards.  And you’ll also want to pay attention to the changes that have been made to the language in Clauses 4.1.3 and 5.3.2.

Of course Document Center customers have already received their notifications about the new amendments.   If you’d like this type of timely updating and convenient ordering, you can purchase your copies of the new releases at our webstore, www.document-center.com.  Or you may prefer to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Authorized copies of ISO standards are available in paper format, for pdf download, and as part of custom online access subscriptions.

Document Center Inc. has been a distributor of ISO standards since the 1990′s.  We’ve helped thousands of customers just like you with maintaining and understanding conformance documentation collections.  Make us your Standards Experts too!