Tag: ISO 14644-1

ISO 14644-1 Update Released!

ISO 14644-1, “Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration,” has just been updated and the new 2nd Edition is available from Document Center Inc. now!  This highly-anticipated revision was expected in 2016, so the 12/15/2015 release is ISO’s Christmas present to those of you responsible for cleanrooms or clean zones.

FYI: ISO 14644-2 2nd Edition has also been released and I will review the new revision tomorrow…

What is the ISO 14644-1?  This is the widely-used standard that specifies classes of air cleanliness based on the number of particles per volume of air.  It also tells you how to test for air cleanliness, including information on how to choose the locations for sampling.  It is referenced as part of the standard operating procedures of cleanrooms used in such industries as diverse as aerospace, medical devices, healthcare, food, microelectronics and pharmaceuticals.

What are the changes in the new 2nd Edition for ISO 14644-1?  This is a technical revision and replaces the 1st Edition which is now obsolete.  The 9 cleanliness classes have minor revisions.  Nanoparticles (or ultrafine particles) are being moved to a proposed new Part of the 14644 series.  Table 1 provides you with the definition of particle concentration for the 9 classes.  Table E.1 (in Annex E) defines the maximum particle concentration at various particle sizes for intermediate classes.

However, the most significant changes in this new revision are the modifications to the selections of statistical approaches and of location(s) for sampling itself.  The new approach means that you’ll have a 95% level of confidence in the particle concentration in at least 90% of the clean room/zone areas.  In addition, the Annexes have been reordered for a more logical format.  And the ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S and WHO GMPs is addressed as well (by way of an adaptation of the macroparticle concept.)

One last feature of note:  ISO 14644-1 now includes all matters related to classification of air cleanliness by particle concentration. The new ISO 14644-2:2015 now deals exclusively with the monitoring of air cleanliness by particle concentration.  I’ll discuss this more tomorrow…

Of course, if you’re responsible for a cleanroom or clean zone, you’ll need a copy of the new standard(s).  Order with confidence at the Document Center Inc. webstore www.document-center.com.  We’re an authorized distributor for ISO standards and have been working with the organization since the 1980’s.  Here’s the direct link for the order page for ISO 14644-1 and also for the ISO 14644-2.

If you do have additional questions, feel free to contact our staff.  You’ll find they are knowledgeable about standards and can help you with many of the concerns you may have regarding the proper use and maintenance of these compliance documents.  Reach them by phone (650-591-7600) or by email (info@document-center.com).  They be able to help you immediately.  That’s why you should be sure to make Document Center Inc. your Standards Experts!

ISO 14644-1 and ISO 14644-2 Final Drafts are here for Cleanrooms

ISO 14644-1 and ISO 14644-2 are scheduled to be updated early next year.  For those of you who maintain cleanroom environments, these two standards are essential.  For that reason, Document Center Inc. has the final drafts of both 2016 Editions available for you now.  These drafts contain the exact language that will be in the new updates when they are released.  However, they do not take the place of the authorized editions and should be used for pre-planning purposes.

Why would you want the Final Drafts for ISO 14644-1 and ISO 14644-2 2016 Editions?  These drafts allow you to start your gap analysis immediately.  There will be transition time once the 2nd Editions of each are released, but taking a look at the final drafts now will help you speed up that migration period.

What should you expect to see in the new 2nd Editions for ISO 14644-1 and ISO 14644-2?

For the ISO 14644-1, “Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration,” the primary update is the use of a two-method sampling scheme.  You’ll now use a randomized sampling location selection technique along with a risk-assessed, fixed-location sampling technique.  This means you’ll define those areas in your clean room that are most likely to suffer from contamination.  Then you’ll sample those areas in conjunction with your random sampling to improve the over-all quality control of your environment.  This will be particularly useful for life science and pharmaceutical applications.  And you’ll find enhanced guidance for particle counter calibration as well.

ISO 14644-2, “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom preformance related to air cleanliness by particle concentration,”  now includes the need for a monitoring strategy in addition to your initial or periodic testing.  The result?  A continuing flow of data over time based on risk for a more detailed view of the installation’s performance.

You certainly may prefer to wait until the authorized editions are released.  As you probably know, drafts are not the same as the authorized editions and cannot be used in their stead.  However, they do provide a relatively inexpensive way to prepare for upcoming changes.

To get your copies, head to the Document Center Inc. webstore at www.document-center.com.  You can order any ISO standard you need, as well as many obsolete and draft editions.  Here’s the order page for the ISO 14644-1 final draft and the order page for the ISO 14644-2 final draft.  Until these new editions are published, the 1st Editions of both documents remain valid.

Questions?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Document Center is an authorized distributor of ISO standards and we’re here to help you with any and all questions, requirements, or issues you may have with this standards set.  Make us your Standards Experts!

MIL-STD-883 H – The DoD’s top standard for Microcircuits — Plus a list of other relevant standards

MIL-STD-883 Revision H, entitled “Test Method Standard – Microcircuits,” is Document Center’s all-time best selling military standard.  It provides approximately 700 pages of tests for microelectronic devices suitable for use within Military and Aerospace electronic systems.  It includes basic environmental tests to determine resistance to deleterious effects of natural elements and conditions surrounding military and space operations; mechanical and electrical tests; and workmanship and training procedures.

Revision H was released on 2/26/2010 and compliance with the standard was required by 9/30/2010.  Usage of the standard is mandated as part of a contract with the U.S. government.

The document is intended to be used in conjunction with several other major military documents:
MIL-PRF-19500 – Semiconductor Devices, General Specification For.
MIL-PRF-38534 – Hybrid Microcircuits, General Specification For.
MIL-PRF-38535 – Integrated Circuits (Microcircuits) Manufacturing, General Specification For.
MIL-STD-1835 – Electronic Component Case Outlines.
MIL-HDBK-217 – Reliability Prediction of Electronic Equipment.
MIL-HDBK-505 – Definitions of Item Levels, Item Exchangeability, Models, and Related Terms.

There are also references to a number of industry standards that are basic to any standard library for electronic devices:

ISO 14644-1 – Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness.
ISO 14644-2 – Cleanrooms and Associated Controlled Environments – Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1.
IPC-T-50 – Terms and Definitions for Interconnecting and Packaging Electronic Circuits.
ANSI/NCSL Z540.3 – Requirements for the Calibration of Measuring and Test Equipment, General Requirements
ANSI/J-STD-004 – Requirements for Soldering Fluxes
ANSI/J-STD-005 Requirements for Soldering Pastes
ANSI/J-STD-006 – Requirements for Electronic Grade Solder Alloys and Fluxed and Non-fluxed Solid Solders for Electronic Soldering Applications
IPC/EIA/JEDEC J-STD-002 Solderability Tests for Component Leads, Terminations, Lugs, Terminals and Wires.
EIA/JESD 22-B116 Wire Bond Shear Test
EIA/JESD 78 IC Latch-up Test.
EIA-557 Statistical Process Control Systems.
ASTM E263 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Iron.
ASTM E264 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Nickel.
ASTM E265 – Standard Test Method for Measuring Reaction Rates and Fast-Neutron Fluences by Radioactivation of Sulfur-32.
ASTM E666 – Standard Practice for Calculating Absorbed Dose from Gamma or X-Radiation.
ASTM E668 – Standard Practice for Application of Thermoluminescence-Dosimetry (TLD) Systems for Determining Absorbed Dose on Radiation Hardness Testing of Electronic Devices.
ASTM E720 – Standard Guide for Selection and Use of Neutron Sensors for Determining Neutron Spectra Employed in Radiation-Hardness Testing of Electronics.
ASTM E721 Standard Method for Determining Neutron Energy Spectra with Neutron-Activation Foils for Radiation-Hardness Testing of Electronics.
ASTM E722 – Standard Practice for Characterizing Neutron Energy Fluence Spectra in Terms of an equivalent Monoenergetic Neutron Fluence for Radiation-Hardness Testing of Electronics.
ASTM E801 Standard Practice for Controlling Quality of Radiological Examination of Electronic Devices.
ASTM E831 Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
ASTM E1249 – Minimizing Dosimetry Errors in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1250 – Standard Method for Application of Ionization Chambers to Assess the Low Energy Gamma Component of Cobalt 60 Irradiators Used in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1275 – Standard Practice for Use of a Radiochromic Film Dosimetry System.
ASTM F458 – Standard Practice for Nondestructive Pull Testing of Wire Bonds.
ASTM F459 – Standard Test Methods for Measuring Pull Strength of Microelectronic Wire Bonds.
ASTM F526 – Standard Test Method for Measuring Dose for Use in Linear Accelerator Pulsed Radiation Effects Tests.
ASTM F1892 – Standard Guide for Ionizing Radiation (Total Dose) Effects Testing of Semiconductor Devices.
ASTM C177 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded Hot-Plate Apparatus.
ASTM C518 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus.
ASTM D150 – Standard Test Methods for A-C Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating Materials.
ASTM D257 – Standard Test Methods for D-C Resistance or Conductance of Insulating Materials.
ASTM D1002 – Standard Test Method for Strength Properties of Adhesives in Shear by Tension Loading (Metal-to-Metal).
ASTM D3850 – Standard Test Method for Rapid Thermal Degradation of Solid Electrical Insulating Materials By Thermogravimetric Method (TGA).

The MIL-STD-883, both the current Revision H and previous editions, as well as the other standards noted above, are all available from Document Center Inc.  Use our website, www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email us (info@document-center.com).  Any questions or comments you may have are welcome.