What is a CB?

What is a CB?  Terms and acronyms are thrown about with abandon here in the standards world.  Take for example the term “CB.”  It stands for “Certification Body,” sometimes known as an accredited registrar.  These are organizations that have been recognized by an accreditation body like the ANAB, the EPA, SAAS and so on.  CB’s have the credentials to perform audits and reviews that lead to registration or certification for a particular standard, code or labeling requirement.

Let’s think of the process of certification in terms of a three-tier structure.  At the top is the standard or other set of requirements needed to meet the certification criteria.  In the middle are the folks who are qualified to see if an organization meets those criteria.  At the bottom are all the companies that have proved that their products and services meet the standard.

The top tier — standards developer and accreditor — may be the same or may be divided into two separate organizations.  So when the EPA sets up the WaterSense program or the EnergyStar program, it sets the criteria for compliance and determines what laboratories and other certification groups are qualified to audit to those criteria.

There is usually a slight difference when a standards developing organization (SDO) writes a standard that will be used for certification.  In order to avoid the suggestion of a conflict of interest, it is not uncommon for the SDO to hand over the accreditation part of the process to an outside party.  This is to avoid any appearance of favoritism or other mishandling of those services.  So that’s the reason the ANAB has been set up here in the U.S. as an example.

How can you find a certified body when you’re ready?  First of all, you’ll want to use the schema for your certification as the jumping-off point.  If you want to be certified for an EPA program, you’ll check in with that program to see who’s qualified to audit and approve you.  So for WaterSense, there’s a list of both accreditation bodies and certified bodies at http://www.epa.gov/watersense/about_us/cert_bodies.html.  A similar site for the EnergyStar program is at https://www.energystar.gov/index.cfm?fuseaction=recognized_bodies_list.show_RCB_search_form.

In some instances the source for this information is based on your jurisdiction (location).  So for ISO 9001 certification, for example, U.S. companies would go to the ANAB, European companies would choose the NAB (National Accreditation Body) for their country, and Australia/New Zealand rely on JAS ANZ.  If you’re not sure what accreditation bodies exist in your area, check in with the listing for the membership of the  International Accreditation Forum.  It’s arranged by country for your convenience.

One thing that you’re sure to notice is that accreditators often will be able to authorize CB’s for a range of certification programs.  So if you have more than one certification scheme in your business, this is an opportunity to see if one CB can handle them all for you.

Last question.  Why use a Certified Body?  Unless you have official registration for a certification scheme, you are not authorized to use a label, mark or other promotion for that program.  Like all things, you are buying a service when you use a Certification Body.  So make sure that you’re confident of the organizations credentials before you sign on for your audit and registration!

Many times, your certification will require you to have and use specific standards.  If so, consider using Document Center Inc. as your source for your compliance documentation.  We’ve been selling standards since 1982 and you can review and order from our catalog at any time at www.document-center.com.  Make us your standards experts!

BS OHSAS 18002 Updated

BS OHSAS 18002, “Occupational health and safety management systems. Guidelines for the implementation of OHSAS 18001:2007,” has been updated with the released of Corrigendum 1, a correction to the text.  This corrigendum to the 2008 Edition was released at the end of August.  It is a minor correction, involving the title and supersession information.  It is applicable only to the British implementation of the OHSAS 18002, as noted above.

The OHSAS standards are written by a group of interested parties under the banner of the Occupational Health and Safety Assessment Series (OHSAS) Project Group.  These many participants are listed at the beginning of each of their publications, which are available in many national editions.  They include many national standards bodies, certification, accreditation bodies, occupational health and safety institutes, industry associations, consulting organizations and government agencies.  BSI acts as the secretariat.

There are two primary documents, the OHSAS 18001, “Occupational health and safety management systems. Requirements,” and the OHSAS 18002, the guideline for implementation.  The BSI standards organization has also published an additional standard, BS-18004, “Guide to achieving effective occupational health and safety performance.”

FYI:  The OHSAS standards were developed with an eye to migration as International Standards under the ISO umbrella.  This is actually occuring right now with the development of the ISO 45001, “Occupational health and safety management systems – Requirements.”  Since this ISO version is still a committee draft, it is not publicly available yet.  Changes from the OHSAS to ISO Editions will include changes reflecting the recent new emphasis in ISO management system standards to the context of the organization and a stronger role for management (leadership).

I must admit that I took a look at both the previous and corrected  editions of the BS OHSAS 18002 document and I have yet to see where the two differ.  However, there is a new cover page referencing the corrigendum and the usual line under the “Amendments issued since publication.”  So it must be there somewhere!

BS Standards are routinely updated by republishing the entire standard.  So you’ll not be able to get the corrigendum all by itself.  There is a nominal processing fee here at Document Center Inc. for those of you who have purchased this standard from us in the past.  For those who have not, the BS OHSAS 18002 will need to be purchased in it’s entirety.  I will also note that the source document, OHSAS 18002, has not yet been released with any corrigendum.  So at this point it appears to be a correction only for the British edition.

When you go to order your copy, you’ll need to use an authorized Standards Distributor like Document Center Inc.  You can search for and order standards using our catalog at www.document-center.com.  Here is a direct link to the order page for BS OHSAS 18002.  Since we’ve been working with standards since 1982 we’ve developed many other services to assist standards users like you.  For more information on our company and our products, please get in touch with our staff.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New ISO Dentistry Standards Released

ISO has  released three new Dentistry Standards.  Since Document Center Inc. has a number of customers who design, manufacture and market dental products, we like to review new issues when they occur.  Standards play an important role in assuring customers and end-users of safe and effective dental products.  One of these new releases is on endodontic instruments (ISO 3630-3), one is on sealants (ISO 6874) and one is for periodontal instruments (ISO 13397-5).  We’ll review each of these separately.

ISO 3630-3, 2nd Edition, “Dentistry – Endodontic instruments – Part 3: Compactors: pluggers and spreaders”  You’ll get information on size, marking, product designation, safety considerations, labeling and packaging in this standard.

Endodontic instruments are basically used for root canal work.  Part 3 deals exclusively with such instruments used to compact endodontic fillinf materials that are not specified in the other parts of the series.

The new 2nd Edition cancels and replaces the 1st Edition from 1994.  It has been technically revised, with changes occuring in the definition of “condenser” (now “compactor”), updates to clauses 5 and 7 (finger instruments and hand instruments are differentiated), and the deletion of plugger sizes 015 and 020 from Table 1.  Reprocessing requirements have also been added.

ISO 6874, 3rd Edition, “Dentistry – Polymer-based pit and fissure sealants”

This new 3rd Edition cancels and replaces the 2nd Edition from 2005.  However, it is considered a minor revision.  It addresses polymer-based materials that are used as pit and fissure sealants for preventing dental decay.  The materials covered in the ISO 6874 may be hardened either during the mixing process or by external energy (light).  FYI:  The issue of biological hazards of such material are not included, but should be addressed by the use of the ISO 10993 series and ISO 7405.

ISO 13397-5, 1st Edition, Dentistry – Periodontal curettes, dental scalers and excavators – Part 5: Jacquette scalers

The ISO 13397 series provides requirements for periodontal instruments.  As such, the series is slowly expanding to include more parts as the committee is able to produce them.  This new Part 5 is such an expansion.  It provides you with the designs and dimensions for Jacquette scalers.

Periodontal scalers are those sharp instruments that are used to remove deposits from your teeth.  A jacuqette scaler is a straight-bladed scaler with two cutting edges that end in a sharp point.  Your dental technician or dentist will use this device to remove supragingival and/or interproximal deposits (plaque).  It’s also sometimes called a sickle scaler.

Now to get your copies of one or more of these Dental Standards.  You’ll want to use an authorized distributor for your purchase.  So use the Document Center webstore at www.document-center.com.  Here are direct links to the order pages for ISO 3630-3, ISO 6874, and ISO 13397-5.  And here is our Document Center List of Standards on Dental Equipment.  You’ll be able to order your standards in either paper format or for pdf download.

Would you like to include any of the ISO standards in a multi-user “standards in the cloud” service?  Ask our staff about our Standards Online subscription access to the standards you use in your business.  It’s a great way to ensure 24/7 availability of the standards you use.  Contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  Remember:  We’re your Standards Experts!

IEC 60533 Updated

IEC 60533, “Electrical and electronic installations in ships – Electromagnetic compatibility (EMC) – Ships with a metallic hull,” has been updated.  The new Edition 3.0 is available now from Document Center Inc.  This update replaces the previous Edition 2.0, which is now obsolete.

The IEC 60533 centers on the control of harmful electromagnetic emissions.  This is to prevent the possibility of other equipment being influenced by the installation in question.  It specifically looks at ships with metallic hulls, since that structural formation can attenuate electromagnetic disturbances from outer deck environments to inner deck ones, and vice versa.  And it also reviews special risks like lightning strikes, electromagnetic radiation from radio transponders and transients from the operation of circuit breakers.

The new IEC 60533 update is a significant change from the previous edition.  Updates include the following:

  • An expanded introduction
  • Reduction of the scope of the standard to ships with metal hulls only (reflected in the updated title of the standard)
  • Updates to the referenced documents section
  • Clause 5.1 has a further explanation of in-situ testing
  • Tables 1, 2 and 3 are updated (the numbering of the CISPR standards)
  • Annex B has had a title change
  • Requirements on cable routing in Annex B have also changed
  • There’s a new Annex C on EMC test reports.

If you need more exacting information on the changes in this standard, there is a redline edition available.  Here you’ll see all the modifications that were made to the previous Edition 2.0.

If you need a copy of this new release (or of any IEC standard), you’ll want to follow IEC’s directive to purchase your copy from an authorized distributor.  Document Center Inc. is such a supplier, having worked with IEC standards since the 1980’s.  You can search and order your standards online at www.document-center.com.  The IEC standards can be purchased there with confidence, in both paper format and for pdf download.  Here’s a link directly to the order page for IEC 60533.

Many of our customers prefer multi-user online access and we have developed our Standards Online service specifically for this situation.  To get information on starting your “standards collection in the cloud,” contact our staff.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Make us your Standards Experts!

New ISO 7250-3 – Body sizes for equipment design

ISO 7250-3, “Basic human body measurements for technological design – Part 3: Worldwide and regional design ranges for use in product standards,” has just been released.  It complements the previous two parts of ISO 7250 that are already in circulation.  It presents a unified anthropometric schema for worldwide product distribution as well as for regional distribution in both Europe and Asia. To do this it takes the more specific information presented in the ISO/TR 7250-2 and generalizes it as noted.

This concept of developing a kind of anthropometric baseline is valuable to folks in the automotive and aerospace industries, medical device manufacturers, and developers of other products that need to be tailored to the bodily dimensions of users.  So the first task of the ISO 7250 standards developers was to determine what measurements needed to be sampled.  This led to the release of ISO 7250-1, “Basic human body measurements for technological design — Part 1: Body measurement definitions and landmarks,” in 2008.

Next the actual statistics needed to be generated for various populations and so far this has been a country by country effort.  The ISO/TR 7250-2, “Basic human body measurements for technological design — Part 2: Statistical summaries of body measurements from national populations,” presents actual data from the following jurisdictions:  Austria, China, Germany, Italy, Japan, Kenya, Korea, the Netherlands, Thailand and the United States.  Some of the data is complete, that is all measurements from Part 1 are included, both for men and women.  Some is not.

Now the ISO 7250-3 completes the picture, using the specific data from the ISO/TR 7250-2 sources to present a more generalized range for worldwide averages, as well as for Europeans and Asians.  The tables that present this data are based on the schema of the Part 1.  They present you with each specific measurement as P1 (1st percentile) data, P5 (5th percentile) data, P95 (95th percentile) data and P99 (99th percentile) data.  There’s also a column for the midrange.  Annex A provides you with the same table structure, only using the European statistical information only.  Annex B is the same for the Asian region.

Data comes from a variety of sources.  For the U.S. information, the CAESAR database held by SAE International is used.  Information is included in this standard on various databases that are updated on a regular basis.  You may find that you end up using the source data and the same underlying process should you have a targeted population your product serves.

Of course, you’ll want to get your copies of any ISO standards you use from an authorized distributor like Document Center Inc.  Our webstore www.document-center.com is available to you 24/7 to search and order standards with confidence.  ISO standards are available in paper format or for pdf download.  They can also be included in our multi-user Standards Online subscription platform.

Here’s a link directly to the order page for ISO 7250-3.  Want to talk with any of our staff members about the standard, the ISO 7250 series, or any other standards questions or requirements you might have?  Just contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New ASTM D1655 2015B Edition – Aviation Turbine Fuels

ASTM D1655, “Standard Specification for Aviation Turbine Fuels,” has just been updated for the third time this year.  The new 2015b Edition replaces all previous editions, which are now cancelled.  The ASTM D1655 is often updated several times a year.  This makes it a great candidate for our Standards Online subscription service.  Not only do you get multi-user access to the standard, it also comes with free updating service during the annual subscription period.

Let’s talk about the specification itself.  ASTM International originally was known as the American Society for Testing and Materials and remains a major standards developer of material standards.  The ASTM D1655 on aviation turbine fuel really typlifies this type of specification.  It’s been in use for many years with an active committee that monitors the publication for necessary changes on a frequent basis.  It’s used by purchasing departments the world over to insure that the fuel that’s used in turbine aircraft meets stringent requirements for consistency and quality.  It’s narrow in focus, 20 pages in length, and available at a reasonable price in a variety of formats to meet user preferences.

As I noted before in a 2011 post (ASTM D1655 2011B Edition) the ASTM D1655 addresses Jet A and Jet A-1 aviation turbine fuels only.  [FYI: ASTM D6615 is used for Jet B fuel.]  There’s a lengthy list of referenced documents (2 1/2 pages worth) that will be used in conjuction with the specification.  The first 8 pages of the specification cover the basics (scope, referenced documents, definitions, classification, materials and manufacture, detailed requirements and so on.)  The balance of the publication consists of an Annex on fuels from non-conventional sources and three Appendixes.  They are informational only.  The first covers performance characteristics of aviation turbine fuels.  The second is on the control of processing additives and distribution.  The third provides you with a form that can be used for reporting inspection data on these fuels.

The committee helpfully lists the recent changes at the end of the specification.  Here’s a brief review of the updates that have been made in the three 2015 revisions:

  • 2015b: Revisions were made to subsection 6.2, table 2, and Appendix X1.15.1.1
  • 2015a: You’ll find updates in Appendix X1.2.1, X1.3.1, X.1.3.2, and X1.3.3, in the use of IP 598 in lieu of IP 57, revisions for Table 2, and updated subsections 1.2 and 1.5.
  • 2015: Changes to Table 1 plus IP designations for Footnote H.  Additional of ASTM D7797 and IP 583 to the referenced documents.  New Section 3 for terminology.  Updates to subsection 6.3.  Revisions of Table 2 (includes the addition of Footnote G) and Table 3 (with Footnotes C and D added as well.)

Remember, all ASTM standards are covered by copyright law and must be purchased from an authorized distributor like Document Center Inc.  You can order any of the ASTM standards you need (including many obsolete revisions) at the Document Center webstore, www.document-center.com.  Here’s a direct link to the order page for ASTM D1655.

As I mentioned before, Standards Online is a great option for these types of ASTM standards that routinely update several times a year.  Contact our staff for more information on this service or just to discuss any standards questions or problems you may be facing.  They can be reached via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Remember: We’re your Standards Experts!

IEC TS 62607-4 Updates for Nanomanufacturing

The IEC TS 62607-4 series on Key control characteristics for Nanomanufacturing has been updated.  There’s a new Edition 2.0 for IEC TS 62607-4-1 and a new Edition 1.0 for IEC TS 62607-4-3.  We’ll review these new two IEC releases one at a time.  The series addresses cathode nanomaterials so important in energy storage moving forward.  Uses include “Smart Grid” applications, transportation, and so on.  These materials support effective energy storage that are key for renewable energy usage.

IEC TS 62607-4-1, “Nanomanufacturing – Key control characteristics – Part 4-1: Cathode nanomaterials for nano-enabled electrical energy storage – Electrochemical characterisation, 2-electrode cell method,” was originally released last year.   After the technical specification was released, IEC TC 113 (the specification’s authoring committee) and IEC TC 21/SC 21A (the committee for secondary cells and batteries containing alkaline or other non-acid) had further discussions regarding the publication.

As a result of those meetings, the title of the document has been changed.  And the scope of the specification has also been modified.  It now clarifies that the publication deals with a method for determining electrochemical properties of cathode nanomaterials.  This might include lithium-ion batteries utilizing lithium iron phosphate for example.  And you’ll find that the definition of “cathode nanomaterial” has been updated to be more concise.  So the new Edition 2.0 for IEC TS 62607-4-1 is indeed a technical update, replacing and cancelling the previous Edition 1.0.

IEC TS 62607-4-3, “Nanomanufacturing – Key control characteristics – Part 4-3: Nano-enabled electrical energy storage – Contact and coating resistivity measurements for nanomaterials,” has just been issued.  This part of the IEC 62607 series provides you with standard methods to measure coating and contact resistivity of nano-enabled electrode materials.  It also allows you to evaluate the best combinations of composite material recipes and fabrication technologies for carbon containing these nano-enabled electrodes.  And using this method, you’ll be able to compare the results of different research groups.

This technical specification has been written for use during the study stage, not for evaluating end products.  Since this material can affect the performance of electrodes even in small quantities, the percentage of the amount of nanomaterial of the device in question doesn’t affect the applicability of this document.  So the fraction of nanomaterials in electrodes, electrode coatings, separators or electrolyte is not relevant for using this specification!  Amazing.

When might you use the IEC TS 62607-4-3?  The test method presented can help you decide if a coating composite material is suitable for your purposes.  And you’ll be able to select the best combinations of coating composite material including the fabrication technologies suitable for their application.

IEC reminds you to always make sure that you purchase your IEC standards from an authorized distributor.  Luckily, Document Center Inc. is such a provider.  So use our website, www.document-center.com, with confidence for your IEC and other standards purchases.  Here are links directly to the order page for IEC TS 62607-4-1 and the order page for IEC TS 62607-4-3.  You’ll be able to choose delivery in paper format or for pdf download.

Want multi-user access to IEC standards for your organization?  Our staff can help you set up a Standards Online subscription account that will be available for your staff from any internet connection.  Find out more by getting in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to help you with all phases of your compliance and quality program.  Make us your Standards Experts!

ISO 9001 2015 Release date – 9/23/2015!

ISO 9001 2015 Edition, “Quality management systems – Requirements,” is officially set to be released on September 23rd, 2015!  For all of you with ISO 9000 Certification, this new 5th Edition will present challenges and opportunities.  You can pre-order your copy now from Document Center Inc. (info@document-center.com). The new ISO 9001:2015 will cost $173.00 and will be available in paper format, for pdf download, and as part of our multi-user Standards Online subscription service.  We know how important this standard is to many of you.  We’re here to support your use of standards like the ISO 9001 for your compliance requirements.

When it comes to transitioning from the ISO 9001 2008 to the ISO 9001 2015, there are many questions about the new requirements and when you’ll need to have made the transition.  Let’s talk about your timeline first and then I’ll offer you some free resources that you may want to take advantage of for your Gap analysis and the implementation of the new update in order to meet the September 2018 deadline.

Normally, for transitioning from one edition to the next, your standards developers like ISO and IEC will recommend a three year migration period.  This is certainly true for the new 5th Edition of the ISO 9001.  However, you may wish to make the move the next time your registration is up for renewal.  Just remember to allow for plenty of time for remediation of any non-conformities that emerge during your audit.

And there may be one additional wrinkle for you — the official adoption of the EN ISO 9001 by the European Union.  Since this is a harmonized standard under Regulation (EC) No 765/2008, you may find that you need to comply with the EN Edition rather than the ISO original.  If so, the harmonized list for that regulation will provide you with a “cessation of presumption of conformity” date.  This is the date when the 2008 Edition will no longer be valid within the European Union and will be your “must transition by” date in that case.

Now, how to figure out what you need to do to make your transition effectively.  Our first stop for clarification is the committee page for ISO TC (Technical Committee) 176 Sub-committee 2, the “owners” of the ISO 9000 Quality Standards series.  You’ll find them at  http://isotc.iso.org/livelink/livelink/open/tc176SC2publichttp://isotc.iso.org/livelink/livelink/open/tc176SC2public.  As you scroll down their page, you’ll find a number of useful documents, including their ISO 9001 Implementation Guidance.  Another useful tool is the IAF (International Accreditation Forum, Inc.) article entitled “Transition Planning Guidance for ISO 9001:2015.”

Additionally, a number of Certified Bodies and Notified Bodies have material available to assist you.  BSI offers a useful transition guide, “The New ISO 9001, BSI’s Best Practice Transition Journey.”  It’s a basic guide to how to set up a plan for the migration itself.  Perry Johnson Registrars offers another view of the same issue with it’s “Preparing for the Change – Transition to ISO 9001:2015 .”

There’s also material directly addressing the problems of Gap analysis that you’ll need to do in order to assure that all issues in the new edition have been addressed within your organization.  One of my favorites is NQA’s (National Quality Assurance)  ISO 9001 2015 Transition Gap Analysis publication.  TUV offers a similar review, this time including a checklist that you may find to be helpful.  It’s their “ISO 9001:2015 Revision  – Guidance & Self Evaluation Checklist.”

Lastly, there’s the question of which edition you should purchase.  You’ll find that there are many to choose from: The ISO 9001 original, regional adoptions like the EN ISO 9001, and a plethora of national adoptions like the ASQ Q9001 here in the U.S.  Reasons to pick one over the other may have to do with regulatory requirements, as noted in the discussion of the EN ISO 9001 above.  Or they may have to do with the formats a standard is available in or the costs involved.

Our Document Center staff can help you understand the various criteria.  And you can always take a look on our website for yourself!  Just search at www.document-center.com.   We’re setting up a specific page for the ISO 9000 and ISO 9001 2015 Editions, and I’ll add a link to that when it’s available.  Meantime, should you have any additional questions, please get in touch with us via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

MIL-STD-981 C Updated – Electromagnetic Devices for Space!

MIL-STD-981 C, “Design, Manufacturing and Quality Standards for Custom Electromagnetic Devices for Space Applications,” has been updated with the release of Revision C interfiled with Notices 1 and 2.  The standard is the technical baseline for custom electromagnetic devices for space applications.  These include such products as transformers, inductors, coils, charging inductors, and the like.  They are used in critical space applications, mission-essential ground equipment, and also in noncritical flight and ground support applications as well.

The 68-page standard was released as the Revision C back in 2010 with 1 other round of updates occuring when Notice 1 was issued in 2014.  When Change Notices like this are used, the updates are usually not extensive and this is certainly true with the recent release of Change Notice 2.  For the user’s convenience, black lines in the margin are used to point out the areas in the standard when updates have been made.  That is the case in this consolidated release.

You’ll find the margin alerts for MIL-STD-981 C’s Notice 2 in the following areas:

  • Clause on Cores.
  • Appendix B, Section B.
  • Appendix B, Section B.
  • Appendix B Figure B-3

You are still responsible for implementing any other updates that might have occured without the margin lines.  They are just there “for your convenience.”

What is actually included in MIL-STD-981?  The standard is layed out in the usual format:  Scope, Applicable Documents, and Definitions.  General Requirements follow, both for general procurement requirements and for the various types of devices covered by the standard.  Section 5, Detailed Requirements, is a lengthier review of the types of materials, inspections, markings, quality requirements, and so on that are expected for items delivered to meet this standard.  A short Section 6 with notes concludes the standard itself.

Two Appendices provide additional material.  Appendix A discusses the product assurance program required by this document.  Appendix B gives you information on real time X-ray (radiographic) inspection needed for compliance.

Now you’ll need a copy.  When you use Document Center Inc. as your supplier, you’ll have the option of purchasing your copy in paper format, for pdf download or as part of our Standards Online multi-user subscription service.  And you’ll automatically get our Standards Notification as well.  So you’ll be secure in the knowledge that when your standards are revised, you’ll be alerted!

Order at our webstore, www.document-center.com.  Here’s the direct link for the order page for MIL-STD-981.  Should you have questions, our knowledgeable staff can assist you.  Reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping U.S. Government contractors since 1982.  Make us your Standards Experts!

EN ISO 13408-1 Updated – Medical Device Sterility

EN ISO 13408-1, “Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013),” has just been updated.  The new 2015 Edition is available from Document Center Inc. in paper format, as a pdf download, or as part of our multi-user subscription service, Standards Online.  The EN ISO 13408-1 is a harmonized standard for the European Directives 90/385/EEC, 93/42/EEC, and 98/79/EC.  Official acceptance of this new edition is expected.  When this occurs, a notice will be published in the Official Journal and the list of harmonized standards for each of the three medical device directives will be updated.

The previous edition of this ISO adoption also was identical to the ISO 13408-1:2008, including Amd 1:2013.  So what has changed in this update?  Firstly, this edition includes the mandate that the EN ISO editions should be substituted for the use of any original ISO editions for those standards in the referenced documents section (if available).  There is a table that specifies which of the referenced documents does have an EN adoption equivalent, including issue date for both the ISO and IEC originals and the EN adoptions themselves.

Next, the Z Annexes are expanded.  Since the standard is part of the harmonized lists of three directives, there are three Z Annexes — one for each of the applicable directives.  As I’ve mentioned before, these Z Annexes give you complete information on what’s termed “presumption of conformity,” that is, how adherance to the standard will meet essential requirements of the directive in question.  This is accomplished by a direct one-to-one correlation of the clauses of the standard to specific essential requirements that will be met by using the standard.

Over the last couple of years, this understanding of how medical device standards in particular meet the essential requirements of their directives has changed, most notibly with reference to risk management.  So those of you using these standards have had something of a chore wrapping your head around this situation.  The new Z Annexes clarify this to some degree.  However, you may still be left with a few questions.

Firstly,   you need to remember that above all your products that are sold in Europe need to meet the essential requirements of all applicable Directives.  So while the use of appropriate standards can make this easier, it may still leave you with essential requirements that are unmet.

Next, you’ll need to review the applicable Z Annex against the original Directive to see if there are any essential requirements that are unmet by the standard but still apply to your product.  If any non-met essential requirements aren’t applicable, there’s no need to worry any further.  However, if there are still essential requirements that apply to your product and are not covered by the standard you’ll need to take alternative paths to prove you meet the requirement none-the-less.

Where do these Z Annexes differ from those of the past?  First there are 4 notes that are new.  Note 1 and Note 2 clarify some basic risk management concepts that were unaddressed previously.  Note 3 again reiterates that the EN adoptions of referenced documents are being used.  Note 4 reminds you that if an essential requirement is not included in the Annex, it is not met by the standard.  The Z Annex tables then have more detailed information about presumption of conformity given by adherance to this standard.

If you use this standard, you’ll want to get a copy as soon as possible to begin your gap analysis, since formal adoption as a harmonized standard is expected although no firm date on this is available yet.  You have a number of choices.  Here at Document Center Inc. we suggest purchasing the SS EN ISO 13408-1.  It is low priced and is available in paper, for pdf download and for multi-user access.  Here is the direct link to the order page for SS EN ISO 13408-1.  We also have it available as the BS EN ISO 13408-1.  However that edition is available in paper format only.  The DIN EN ISO 13408-1 has not been released in the new edition yet.  Remember, any of the European National editions are as good as any other.

Still have questions?  You’ll find our staff to be most helpful in assisting you with your purchasing decisions and other standards questions.  Reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Want to find and order a standard from our extensive online catalog?  Head to www.document-center.com now.  We’ve been working with standards since 1982.  Make us your Standards Experts!