New ISO/DIS 14644-2 – Cleanroom Monitoring

October 3rd, 2014

In tandem with the release of ISO/DIS 14644-1 (reviewed in Wednesday’s blog), there’s been the release of ISO/DIS 14644-2.  It’s a proposed revision of ISO 14644-2 to be titled “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.”  You’ll get the draft to take a look at possible changes to the document and to allow for comments that you might want to make to the committee regarding these proposed updates.

The difference between ISO 14644-1 and ISO 14644-2 is that the Part 2 provides you with information on air cleanliness over time, rather than just a one-time at-rest reading.  Developing a strategy for this type of monitoring allows for more effective risk analysis, with potential for reduction of operational and product losses.

Some of the things you’ll notice that are different in this proposed 2nd edition are the expansion of the requirements from Section 3 on terms and definitions and Section 4 on demonstration of continued compliance.  In the draft, there are 3 areas of requirements:

  • Section 3 on terms and definitions
  • Section 4 on creating, implementing and maintaining a monitoring plan
  • Section 5 on periodic classification of air cleanliness using particle concentration (ACP)

The informative Annexes have also been revised.  Now Annex A covers matters to consider when developing your monitoring plan.  Annex B provides you with considerations for setting alert and action levels.

As you can see, use of the document over time has resulted in a different slant to the content of the standard.  Since this is a draft, the changes are not yet authorized.  However, many folks do find it helpful to understand the direction of future requirements.  If you’d like to review the new document, you’ll need a copy.  You can order yours at the Document Center website,  Or you can contact our staff by phone (650-591-7600), email ( or even by fax (650-591-7617).

Since comments are due by November, this gives you some time to reflect and possibly contact the committee with your opinions.  And if you need a resource that not only provides you with standards but also provides you with additional services to make them easier to use, you’ll be glad you’ve chosen Document Center.  We’ve been supporting standards users like you since 1982.  Make us your Standards Experts!

New ISO 10993-3 3rd Edition – Biological Evaluation of Medical Devices

October 2nd, 2014

Medical device manufacturers need to do a battery of testing prior to the release of any products as part of regulatory and quality requirements.  Biological evaluation, the interaction of the device with biological tissues, is a major concern.  So those in the medical device industry will want to know that there’s a new 3rd Edition available for ISO 10993-3.  Titled “Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,”  this is part of the 19-document series from ISO.  It is a technical revision of the 2nd edition (which is now obsolete) and is 42 pages in length compared to the previous 23 page revision.

What are the changes in the ISO 10993-3 3rd Edition?  As you can see from the additional pages, there’s a lot of new material.  Let’s review the areas where the standard has been updated:

  • The test strategy of the standard has been modified by the addition of an in vivo test and follow-up evaluation.
  • There’s a new Annex A which provides guidance on selecting the appropriate sample preparation procedure in genotoxicity testing.  This includes further in vitro and in vivo tests.
  • There’s also a new Annex B that’s a flowchart for follow-up evaluation.
  • Annex E has been changed to “Considerations for carcinogenicity studies performed as implantation studies.”  This is a requirement now, not just informative.
  • And there’s a new Annex F on in vitro tests for embryo toxicity as well.

Other news for those of you who use this standard — A new ISO 10993-33 is in the works.  When it is published, it is expected that the title will be “Biological evaluation of medical devices – Part 33:  Supplement to ISO 10993-3: – Guidance on tests to evaluate genotoxicity.”  The document should be released as a Technical Report.

You’ll want to purchase a copy of the new edition, so head to the Document Center Inc. website at and order your copy now.  You’ll be able to get the standard in both paper format and for pdf download.  If you’d like to have it as part of our Standards Online multi-use subscription service, contact our staff by phone (650-591-7600), email ( or fax (650-591-7617).  We’re here to assist you with your compliance documentation requirements.  Make us your Standards Experts!

ISO/DIS 14644-1 Draft Issued for Cleanrooms

October 1st, 2014

ISO 14644-1, “Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness,” has been the go-to document for cleanrooms here in the U.S. ever since FED-STD-209 was cancelled back in 2001.   Now ISO Committee TC 209 has issued the ISO/DIS 14644-1 draft for a proposed 2nd Edition.  If you like to take a look at upcoming changes, or make comments, this is your chance!  Voting on this draft document will happen on November 18th.  But you’ll need a copy in order to review the updates and you can get yours from Document Center Inc. now.

ISO 14644-1 provides you with information on how air cleanliness is classified according to the concentration of particulate matter.  It’s one of an 11 part series addressing the whole issue of cleanrooms and is the starting point for implementation of the series.

The new draft ISO/DIS-14644-1 covers classification of particle populations based on particle size that has a lower limit of 0.1 µm to 5 µm.  It uses  light scattering (discrete) airborne particle counters (LSAPC) to determine the concentration of these particles.  This is done through the use of designated sampling locations.

Of course, until the draft is adopted and published, the current ISO 14644-1 1st Edition remains current.  However, if both parties agree, the new draft document can be referenced in contracts.

If you’re in the aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, or food industries you may find a need to provide a controlled environment during processing.  This is where the ISO 14644 series comes in, since it is the core standards set for accomplishing contamination-sensitive activities.

You’ll want to get copies of the appropriate parts and even the draft documents as well.  And there’s no better place to order than from Document Center.  Our webstore is available at  You’ll find it easy to work with and it has lots of features that can help you identify and monitor the standards you need.  Want to work with our staff to get personal service?  Contact us by phone (650-591-7600), fax (650-591-7617) or email (  We’ve been providing standards from our Silicon Valley location since 1982.  Make us your standards experts!

New Option for EN standards from Document Center Inc.

September 30th, 2014

Looking for a less expensive source for EN standards?  Here at Document Center Inc. we’ve been looking for one too!  Now we are pleased to announce that we have signed an agreement with the Swedish Standards Institute to make the SS Editions of the EN standards available to you!  You’ll find the SS EN standards listed in the Document Center online webstore, with a wide range of delivery options.  And the prices are very attractive!

Are the SS EN editions the same as BS EN and DIN EN editions?  Yes!  They contain the same EN document as the other national editions.  Only the cover sheet material changes from national publication to national publication.

Are the SS EN editions available in English?  Yes!  The standards listed at the Document Center webstore are all available in English, the exact same text as in the other English language national editions.

Are the SS EN editions available for paper format delivery as well as for pdf download?  Yes!  You order these standards in both paper and pdf format right in our store.  They will be sent to you directly when we get your order.

Can I get multi-user licensing access for SS EN standards?  Yes!  All SS editions on our website are available as part of our Standards Online multi-user subscription service.  This means you can have legal access throughout your organization to the EN standards you use.

Are the prices for the SS EN standards reasonable?  Yes!  They are the least expensive editions for most of the EN standards we carry.

Do I have to purchase the whole document over again when an amendment or corrigendum is issued?  No!  With the SS EN standards, you can purchase just the component you need, which will save you a lot of money.

As you can see, Document Center Inc. is really pleased to have such a great partner to allow for more flexibility for our customers, and at a price savings as well!  You’ll find the Swedish Standards Institute to be prompt in it’s adoption of EN standards, so that the lag time between the issue of a new EN document and the national publication will be minimized.  So you’ll get a lot of benefit from choosing the SS EN editions for your standards collection.

Just go to Document Center’s Webstore at  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  We will be able to help you make the transition from other national editions to the SS EN editions.  It’s just part of our mission to help you procure and use standards more effectively!  Make us your Standards Experts!

New MIL-PRF-55110 Revision H on Rigid PWB’s

September 29th, 2014

MIL-PRF-55110, “Printed Wiring Board, Rigid, General Specification for,” has just been revised.  The new Revision H is the first update since Revision G was released with Amendments 1 through 3 back in 2008.  While the specification is inactive (you’ll use MIL-PRF-31032 for new design), it is still widely used for replacement purposes.  If you use the document, you’ll want to get your new edition now.  Compliance with the new Revision H must be completed by April 17, 2015.

The document was originally released as MIL-P-55110, “Printed Wiring Board, General Specification For.”  As part of Mil Spec reform back in the 1990′s, the document was re-classified as a performance specification and given the new number MIL-PRF-55110 to reflect the change.  About 6 months after the transition, the document was inactivated.  However, it continues to be maintained and widely used.

It’s been 6 years since the last update, so changes are extensive (no notations in the margins to help you spot revised material in this new publication).  You’ll expect that as with previous updates, your documentation and processes will be affected.  Having said that, the new Revision H is significantly longer than the previous Revision G.  Why all the new material?  The addition of a number of new Appendices.  Let’s review them:

  • Appendix A – Now Product Assurance Requirements for Qualified Products List Level
  • Appendix B – Now Product Assurance Requirements For Qualified Manufacturer List Programs
  • Appendix C – Still C = 0 Sampling, Test Equipment, And Inspection Facilities
  • Appendix D – Still Supersession, Conformance Inspection Options, And Use Of Legacy Design Standards
  • Appendix E – Now Qualification Requirements For All Levels Of Product Assurance
  • Appendix F – New External Visual And Dimensional Illustrations
  • Appendix G – New Metalographic Illustrations
  • Appendix H – New Quality Conformance Test Circuitry

You’ll notice that the old Appendix E on Sequential Electrochemical Reduction Analysis (SERA) solderability testing is not included in this new edition.

If you use MIL-PRF-55110 in your business, you’ll want to get a copy of the new Revision H.  It’s available to order on the Document Center website,  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  We’ve been supporting the electronics and defense industries since our inception in 1982.  Make us your Standards Experts!

New IEC 62353 Edition 2.0 – Medical Equipment Testing

September 26th, 2014

Once medical electrical equipment leaves the manufacturing floor, there is still the question of routine testing to assure correct performance over time.  And this can include the question of putting a piece of equipment back into use after repair as well.  The IEC 62353 was developed to assist equipment designers and users develop processes for this type of testing to complement the IEC 60601-1 standard.  Titled “Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment,” the new IEC 62353 Edition 2.0 updates and  replaces the original first edition from 2007.

What does the IEC 62353 contain?  It covers the general requirements for testing prior to putting into service, after modifications, after repair, and as part of a recurrent testing protocol.  It gives you  the tests that should be performed under these circumstances.  And it discusses the reporting of the results of your testing and how to evaluate your findings.

Who should be using this standard?  It is intended for use by equipment manufacturers, testing equipment manufacturers, regulatory authorities, equipment suppliers, service personnel and organizational equipment users.

What are the changes in the new 2014 Edition?  As a technical revision, you’ll find important changes in the new revision.  The major changes are:

  • clarification of clause on the measurement of leakage currents (plus more information in Annex A)
  • revision of the protective earth resistance requiprements
  • the addition of expected minimum insulation resistance values in Table 2 and
  • the reordering of the testing sequence found in Annex B.

This document is full of information to assist the user set up and maintain a testing plan for medical electrical equipment.  The 8 Annexes cover a wide range of topics that you’ll want to review, from testing intervals to examples of test documentation.  There’s no shortage of tables illustrating important points and values.  And a 12 item bibliography completes the document.

You’ll want to get a copy of the new edition and you can order it online at the Document Center webstore,  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  You’ll be able to get the IEC 62353 in paper format, for pdf download, or as part of our multi-user online subscription service.  It will come with our best-in-class notification service.  And we have a wide array of additional services that can help you use and maintain your standards more effectively.

Document Center Inc. has been serving customers like you since 1982 from our Silicon Valley location.  We have the experience you need for optimizing your compliance documentation.  Make us your Standards Experts!

New ISO 5832 Updates – Metals for Surgical Implants

September 25th, 2014

The ISO 5832 series specifies metals and alloys used for surgical implants.  Now two of the parts have been updated, ISO 5832-4 and ISO 5832-11.  They cover cobalt-chromium-molybdenum casting alloy and wrought titanium 6-aluminium 7-niobium alloy respectively.  The standards were developed to provide parameters for achieving an acceptable level of biological response for products using these materials.  Let’s review these new revisions one at a time:

ISO 5832-4, 3rd Edition, Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy

This standard specifies the characteristics of and test methods for cobalt-chromium-molybdenum casting alloys for surgical implants.  Table 1 provides you with the elemental constituents of the alloy.  Table 2 covers the mechanical properties required.  And Table 3 is a listing of the test methods necessary (from ISO 6802-1).  Corresponding sections 3, 4, and 5 provide the context for usage.  The obsolete 2nd Edition was released in 1996, so it’s been a while since the document has been changed.

ISO 5832-11, 2nd Edition, Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium alloy

The layout and rationale for the standard are similar to that of the Part 4.  However there is an additional section on microstructure that’s been inserted after the elemental composition clause.  This references ISO 20160, for annealed material.  And again, it’s been some time since the document has been revised, since the now-obsolete 1st Edition was released in 1994.

The complete series is comprised of 12 parts, on the following metals and alloys:

If you use these alloys in your surgical implants, you’ll want to get copies of the new editions.  Go to the Document Center webstore at and order them there.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  We’ll be able to assist you with your purchase as well as offer you additional products and services that will help you maintain your collection of conformance documentation.  We’ve been selling standards from our Silicon Valley location since 1982 and have been on the web since 1993.  Make us your Standards Experts!

New EN 16603-50 Series – Space Communications

September 24th, 2014

The race to commercialize space travel is in the news lately and it’s no surprise that industry standardization is in the mix!  Now there’s a new EN 16603-50 standard and a series of sub parts all focused on space communication systems.  In particular, these new publications cover two of the three components for space communication:  The space link and the space network.  The third aspect – the ground network — is only included when necessary for the provision of end-­to-­end communication services.

The EN 16603 series in full covers space engineering.  Let’s take a look at the EN 16603-50 and the sub-parts that will complete this part of the picture:

EN 16603-50, Space engineering. Communications

This overview document specifies the requirements for the development of the end-­to­-end data communications system for spacecraft. Terminology for space communication systems engineering is covered.  You’ll learn what needs to be done during the space communication system engineering process.  And specific requirements on space communication systems in respect of functionality and performance are included.  It’s for space-­to-­ground and space-­to-­space links used during spacecraft operations, and communications links to the spacecraft used during the assembly, integration and test, and operational phases.

EN 16603-50-01, Space engineering – Space data links – Telemetry synchronization and channel coding

This Standard establishes a common implementation of space telemetry channel coding systems.  And several space telemetry channel coding schemes are specified as well.

EN 16603-50-02, Space engineering. Ranging and Doppler tracking

This Standard is applicable to spacecraft that are supported for ranging or Doppler tracking by direct links to Earth stations and to all related Earth stations.  It is not applicable for spacecraft supported by data relay satellites or for Meteorological Satellite service.  It defines the requirements concerning spacecraft transponder and Earth station equipment.  And it has the criteria for determining how the accuracy of the measurements is influenced by equipment effects.

EN 16603-50-03, Space engineering – Space data links – Telemetry transfer frame protocol

This Standard contains the definition for Telemetry Transfer Frames which are fixed-length data structures, suitable for transmission at a constant frame rate on a space data channel.  Even thought the source of the data is usually located in space and the receiver is located on the ground, the standard can also be used the other way round.

EN 16603-50-04, Space engineering – Space data links – Telecommand protocols, synchronization and channel coding

This Standard specifies the data structures and protocols for a telecommand space data link and the procedure for physical layer operation. Again, the standard can be used for space to ground communications, or vice versa.

EN 16603-50-05,  Space engineering. Radio frequency and modulation

This Standard defines the radio communication techniques used for the transfer of information between spacecraft and Earth stations in both directions, and for the tracking systems used for orbit determination.  It covers:

  • frequency allocation, assignment and use
  • requirements on transmitted signals concerning, for example, spectral occupation, RF power levels, protection of other radio services
  • definition of the permissible modulation methods and parameters
  • specification of the major technical requirements relevant for the interface between spacecraft and Earth stations
  • operational aspects, such as acquisition and
  • cross-support.

EN 16603-50-13, Space engineering. Interface and communication protocol for MIL-STD-1553B data bus onboard spacecraft

The aim of this Standard is to define the interface services and to specify their corresponding bus protocol elements for spacecraft using the MIL-STD-1553 B data bus. It also aims at defining requirements for harmonization of physical interface and usage of the MIL-STD-1553 B data link layer features.  It provides a comprehensive set of requirements for all communication devices and components on board a spacecraft, which are connected to a single (redundant) data bus according to MIL-STD-1553 B.

EN 16603-50-14, Space engineering. Spacecraft discrete interfaces

This Standard specifies a common set of spacecraft on board electrical interfaces for sensor acquisition and actuator control. The interfaces specified in this standard are the traditional point-to-point interfaces that are commonly used on modern spacecraft. The interfaces specified in this standard include analogue and discrete digital interfaces used for status measurement and control, as well as point-to-point serial digital interfaces used for digital data acquisition and commanding of devices.

EN 16603-50-51, Space engineering. SpaceWire protocol identification

There are a number of communication protocols that can be used in conjunction with the SpaceWire Standard to provide a comprehensive set of services for on board user applications.  To distinguish between the various protocols a protocol identifier is used.  This Standard specifies this protocol identifier.

EN 16603-50-52, Space engineering – SpaceWire – Remote memory access protocol

This Standard specifies the Remote Memory Access protocol (RMAP), which is one of these protocols that works over SpaceWire.

As you can see, this is a major undertaking for CEN’s Technical Committee CLC/TC 5.  If you’d like to see more standards on this topic, please go to our Document Center List of Standards on Space Systems and Operations.

And if you need a copy of any of these standards, please order at our webstore,  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  We’ve been supporting the aerospace industry since 1982.  Make us your Standards Experts!

New EN 61000-4-5 2014 Edition

September 23rd, 2014

EN 61000-4-5, “Electromagnetic compatibility (EMC). Testing and measurement techniques. Surge immunity test,” has just been revised.  The new 2014 Edition brings the document back in line with the IEC 61000-4-5 (which was revised in May).  You can get your copy of the new update now from Document Center Inc.

What does this standard cover?  It’s used for defining the requirements and tests for the immunity of electronic and electric equipment to unidirectional surges from over-voltages from switches and lightning.  You’ll get a range of test levels, along with the appropriate test equipment, test setups, and test procedures for compliance.  However, direct lightning strikes are not part of the document.

Since this is an adoption of an IEC standard, the same new material in the IEC edition is present in the EN one as well.  Most changes can be found in the Annexes.  Let’s review them:

  • Annex A has been modified to fully address the issue of surge test for ports connected to outside telecommunication lines,
  • Annex E was added for the mathematical modelling of surge waveforms,
  • New Annex F covers measurement uncertainty,
  • There’s a new Annex G on calibrating impulse measuring systems,
  • And Annex H was added for coupling/decoupling surges to lines rated above 200 A.

What’s in the EN edition that you won’t find in the IEC original?  In the EN forward, you’ll find an endorsement notice.  This notice provides you with the EN equivalents for the IEC documents that are referenced in the Bibliography.  You’ll also find administrative information on when the nations in the EU must adopt this standard and when conflicting or duplicate information needs to be withdrawn.  Additionally, there is a normative (for your information only) Annex ZA.  It refers to referenced documents within the text of the standard.

How can you get your copy of the new EN 61000-4-5?  Go to Document Center’s webstore at  You can order the item both in the original IEC 61000-4-5 edition or in the EN adoptions.  Currently, the BS EN 61000-4-5 is available in English. If you prefer, you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email ( to discuss your options.

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New EN 62368-1 on IT and A/V Equipment Safety Testing

September 22nd, 2014

The “deactivation” of the EN 60950-1 and EN 60065 has moved further along with the release of the new 2014 Edition of the EN 62368-1, “Audio/video, information and communication technology equipment, Safety requirements.”  This new publication is the adoption of the IEC 62368-1 Edition 2.0, which will replace the IEC 60950-1 and the IEC 60065.  The move is anticipated to be complete in 3 to 5 years.

What is the status of the EN 60950-1 and the EN 60065?  Both documents are considered “current, superseded.”  This reflects the transitional situation both are in.  While the IEC 62368-1 Edition 1.0 was not acceptable in Europe (although it has been adopted in the U.S. and elsewhere), the new Edition 2.0 has had the issues rectified.  So the move is on to phase out both the 60950-1 and the 60065.  You’ll have a period when all three standards are current so that you can make the transition from one to the other.

What’s new about the EN 62368-1?  This 2014 Edition is the European adoption of the second edition of the IEC 62368-1.  It contains all the same salient points as the source document.  Most notable?  Here’s our list:

  • The document addresses the issues of safety for both Audio/Visual and ITE (Information Technology Equipment) without being a merging of the 2 older publications.  As a completely new document, it is different than the two publications it is in the process of replacing.
  • It is a hazard-based.  This means that it does not use risk assessment as part of the tool set.
  • It is performance oriented, but does allow for prescribed constructions if they have a track record for safety.
  • It is as technology independent as possible to allow for more design freedom.
  • It is applicable to a broad range of electronic products for easier introduction of new technologies.
  • It has requirements and compliance criteria, including both performance-based and construction-based (prescriptive).
  • The document is compatible with the IECEE CB (Certification Bodies) scheme.  This means there are specific requirements and compliance criteria you’ll need to meet to demonstrate compliance.

So for now, you can continue to use your EN 60950-1 or your EN 60065.  But you’ll want to get the new EN 62368-1 as soon as possible so that you can start to develop your migration strategy.  Where should you go to get your copy?  Document Center Inc. of course!  Currently, the document is available in the BS EN 62368-1 edition.  You’ll have options for the DIN EN 62368-1 and the SS EN 62368-1 soon.  And you can always choose the source document, IEC 62368-1, as well.

Order online at our webstore,  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  Who else can help you understand the transitional situation?  And who else provides you with notification of these types of changes?  Customers have been relying on Document Center since 1982 for superior service and a wide range of supporting products.  Make us your Standards Experts!