New ISO/TR 18786 – Risk Assessment for Welding

September 19th, 2014

Risk assessment standards are gaining favor as a way to identify and prioritize safety concerns in a growing number of industries.  Now the concept has moved into the world of welding and fabrication with the release of the new technical report, ISO/TR 18786.  This document, titled “Health and safety in welding – Guidelines for risk assessment of welding fabrication activities,” addresses hazards for arc welding and similar processes.  It will help you identify things you can do to reduce the risks associated with these activities.  It was developed by the International Institute of Welding (IIW) Commission VIII on health, safety and environment.

It is based on welding processes specified in the ISO 4063, “Welding and allied processes – Nomenclature of processes and reference numbers,” processes 1 (arc welding), 3 (gas welding) and 8 (cutting and gouging).  Joint preparation and grinding are also included.  You’ll find a list of hazards and possible damage that might occur during these activities.  And there’s a guide for possible preventative actions as well.

A nice feature is the discussion and flowchart for the process of risk assessment and possible corrective action at the beginning of the document.  The basic concepts of risk assessment provide the basis of all that follows, so you’ll be able to understand how to use the tables to review your operations.

The Annex A will provide you with a list of the various hazards identified.  They are notated by “H” numbers, each for a specific hazard you might face.  What kinds of hazards will be addressed?  Some examples are ergonomic hazards, dust and fumes, electrical currents and explosive atmospheres.

Annex B covers the list of activities associated with welding.  It includes the relationship of processes to activities and hazards as well.  And commonly used abbreviations for welding processes are also covered with Table B.2.

Lastly Annex C provides you with health and safety management concerns in welding fabrication.  This gives you a list of the actions that you’ll need to take in order to implement a health and safety management system in your facility.  And if you need additional information, you’ll find resources in the 13 item bibliography at the end of the publication.

Now you need to get your copy of this new ISO/TR 18786.  Order yours on the Document Center Inc. webstore, www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  ISO standards are provided in paper format, for pdf download and as part of our multi-user subscription service, Standards Online.  We’ve been helping folks like you since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New ISO 12891-2 2nd Edition – Analysis of retrieved surgical implants

September 18th, 2014

ISO 12891-2, “Retrieval and analysis of surgical implants – Part 2: Analysis of retrieved surgical implants,” has just been updated.  The new 2nd Edition replaces the first edition from 2000.  The document also states that it cancels and withdraws the ISO 12891-3 and ISO 12891-4.  However, ISO still shows these two parts as current right now.  If you are involved in the retrieval or analysis of surgical implants, you’ll want to get a copy from Document Center now.

Of course, there’s many standards and regulations regarding the preparation of medical devices for implanting.  However, the investigation of implants that are removed from patients can provide a wealth of information about performance, effectiveness, and the interaction of the device with the body.  This knowledge then lends itself to improvements in devices themselves, biocompatibility, and functional longevity.

ISO 12891-1 provides the user with information on the proper retrieval and handling of surgical implants.  ISO 12891-2 gives you the methodology for analysis and the protocols for reporting.  It is used not only for implants used in humans, but those in animals as well.  You will want to use the two documents in tandem, since material from one will impact the other.

After a brief discussion of retrieval, handling and packaging (primarily referencing part 1), the document focuses on two main areas:  the analysis of the implant interfaces and analysis of the implant.  Implant interfaces can be of two types: implant to tissue and implant to implant.  Implant analysis itself is more detailed.  It includes the various investigational stages:

  • Stage 1 – Macroscopic, non-destructive examination
  • Stage 2 – Microscopic, mostly non-destructive examination
  • Stage 3 – Material, mostly destructive examination

Surface-treated or coated implants and biodegradable implants are also covered.

The last section deals with implant performance, while Annex A provides you with mandatory forms for reporting and Annex B gives you information on various ISO standards that are applicable for material evaluation.  A 49-item Bibliography finishes up the standard.

If you’re using the ISO 12891 series, you’ll need a copy of the new ISO 12891-2.  When you order from Document Center Inc., you’ll be able to get your copy in paper format, for pdf download or as part of our multi-user subscription service, Standards Online.  Just go to 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 standards to government and industry from our Silicon Valley location since 1982.  Make us your Standards Experts!

New NFPA 99 2015 Code for Health Care Facilities

September 17th, 2014

NFPA produces a series of codes and standards to help reduce the risk of fire, explosions and other  related hazards.  For those in the health care industry, it’s the NFPA 99, “Health Care Facilities Code,” that provides necessary requirements for installation, inspection, testing, maintenance, performance, and safe practices for facilities, material, equipment, and appliances.  Since this includes including medical gas and vacuum systems formerly included in NFPA 99C, you can see how far-reaching this standard is for this industry.  Now there’s a new 2015 Edition and it’s a must for all users of the document.

What can you expect to find in the NFPA 99 2015 Edition?  The document builds on the concept of using risk analysis for patient and staff safety as the basis for it’s requirements.  It brings the NFPA 99 requirements in line with changes to the NEC (NFPA 70, 2014 Edition).  It adds provisions for using fuel cell systems for backup power.  It removes the Type 3 Essential Electrical System requirements.  And it updates terminology and requirements for nurse call systems to align with those of the Facility Guidelines Institute (FGI).

There are a number of new requirements based on the addition of medical gases and vacuum systems to the standard.  These include

  • revised minimum allowable temperature for cylinders for nitrous oxide and carbon dioxide
  • rewritten Category 3 Medical Gas and Vacuum Systems provisions (to harmonize with those of Category 1 and 2 Systems), including dental drive gas and dental vacuum systems
  • and requirements for oxygen-concentrator-based refilling systems.

As noted above, the NFPA 99C was withdrawn in 2012 in favor of the NFPA-99.  If you need further guidance on the topic of gas and vacuum systems in this setting, NFPA suggests that you use the “Medical Gas and Vacuum Systems Installation Handbook.”

Where should you purchase your copies of the NFPA standards you need?  Try Document Center Inc.  You can order online at www.document-center.com or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  What are the benefits?  You’ll not only be notified when your standard is revised, you’ll also receive notification when errata and tentative interim amendments are released.

Document Center Inc. has been working with customers like you since 1982.  We know the challenges you face in maintaining and using the standards required for meeting best practices and other conformance concerns.  We have a wide range of products and services that help others just like you keep up in this challenging environment.  Make us your Standards Experts!

New EN 61000-3-2 – EMC Limits

September 16th, 2014

EN 61000-3-2, “Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase),” has just been updated to bring it up-to-date with the new Edition 4.0 for the IEC 61000-3-2.  The document deals with the limitation of harmonic currents injected into the public supply system.   The new 2014 Edition cancels and replaces the previous 2006 Edition with Amendments 1 and 2.

Like it’s source document, the EN 61000-3-2 is applicable to electrical and electronic equipment having an input current up to and including 16 A per phase.  It specifies limits of harmonic components of the input current.  You’ll be testing your equipment to specific limits, with the tests for particular equipment provided in Annex A.

Since the EN 61000-3-2 is identical in content to the IEC 61000-3-2, the changes to the two standards are the same.  Per IEC, these are:

  • clarification of the repeatability and reproducibility of measurements
  • more accurate specification of the general test conditions for information technology equipment
  • the addition of optional test conditions for information technology equipment with external power supplies or battery chargers
  • the addition of a simplified test method for equipment that undergoes minor changes or updates
  • an update of the test conditions for washing machines, for audio amplifiers, arc welding equipment, and vacuum cleaners
  • clarification of the requirements for Class C equipment with active input power ≤ 25 W
  • clarification of the test conditions for lamps
  • the addition of test conditions for high pressure cleaners
  • the reclassification of refrigerators and freezers with variable-speed drives into Class D
  • and the addition of test conditions for refrigerators and freezers.

You’ll find two informative Annexes in the EN adoption that are not part of the source IEC document.  They are Annex ZA, Normative references to international publications with their corresponding European publications and Annex ZZ, Coverage of essential requirements of EU Directives.  The first Annex just gives you the available parallel EN standards for the IEC standards referenced in the text.   And the second provides you with the relationship of this EN 61000-3-2 with the two directives where requirements can be met with the use of this document.

At this juncture, the EN 61000-3-2 2014 Edition has been released as a BS-EN-61000-3-2.  We expect the SIS-EN-61000-3-2 2014 Edition to be issued soon (the Swedish adoption, English language edition).  The DIN-EN-61000-3-2 2014 Edition is still in draft format with publication probably being issued in the German language format only.

You can get your copy of the new EN 61000-3-2 or the source IEC 61000-3-2 standard from Document Center.  Order online 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 have a number of options, both for format and delivery and for payment as well.  Document Center Inc. has been providing standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New EN ISO 11607-2 available now – Medical Device Packaging

September 15th, 2014

The integrated EN ISO 11607-2, “Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes ,” has just been released.  The document is the European adoption of ISO 11607-2:2006/Amd 1:2014.  It replaces the previous 2006 Edition and is available in paper format, for pdf download, and for multi-user access from Document Center Inc.

If you’ve been following the progress of this series, you’ll know that the integrated 2009 Edition with amendment 1 for EN ISO 11607-1, “Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems,” was issued last month.  The release of the Part 2 completes the adoption of the ISO amendments released earlier this year.

To review the technical content of each of the amendments for ISO 11607-1 and ISO 11607-2, check out my previous blog for a review:  http://standardsforum.com/amendments-update-iso-11607-series.  The EN adoptions contain these changes as issued by ISO.

If you use the two standards and are certified for the European market, you’ll want to get your copies of the new EN ISO 11607-2 revision.  You’ll have some choices.  Here’s what’s available from Document Center, along with general purchasing information to help you decide which is right for you:

BS EN ISO 11607-2, Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

This British national adoption of the EN ISO 11607-2 is available in paper format only.  The price is the highest of any national adoption we sell.  However, it is the official English language edition.

SIS EN ISO 11607-2, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)

This is the Swedish edition of the EN ISO 11607-2.  It’s available in English, in paper format, for pdf download, and as part of our Standards Online multi-user access subscription service.  The price is the lowest of all the adoptions we sell, and the document was released first.  The content is identical to the BS EN ISO 11607-2 except for the differences in the cover sheet material.  That is, the EN English language edition is actually released by CEN and published as is in all the English language copies.

DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes

This is the German national adoption.  As of today, the amending material is only available as a “draft” copy as DIN moves through it’s national adoption process.  We’ll expect to see the new consolidated edition out soon, with copies available in English as well as German.  FYI: The documents are available from Document Center in both paper format and for pdf download.  Prices are usually lower than for the BS Editions, but higher than the Swedish.

So as you see, you have a number of options for procuring your copies of the EN ISO 11607 series.  Order online 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 helping folks like you since 1982.  Make us your Standards Experts!

New IEC/PAS 61182-12 on PCB Assembly Data

September 12th, 2014

There’s a new IEC/PAS 61182-12 available, “Generic requirements for printed board assembly products manufacturing description data and transfer methodology.”  The document provides the user with a wealth of information on the XML schema used to describe PCB’s and PCB assembly products for tooling, manufacturing, assembly and inspection requirements.  Interestingly enough, it is based on a series of IPC documents which have been submitted to IEC for inclusion as an IEC standard.

First, what exactly is an IEC/PAS?  The PAS stands for Publicly Available Standard.  It is a technical specification that does not fulfill all the requirements to be a “real” standard, but is made available to the public because of it’s usefulness or as a precursor to adoption as a standard.  It will only remain valid for three years, by definition.  Then it will be withdrawn or adopted as a regular IEC document (dropping the PAS designation).

It is not uncommon for a PAS document to have dual logos and this is no exception.  You’ll see both the IEC and IPC logos in the upper left hand corner of this document, right there on the front cover.

What IPC standard is the IEC/PAS 61182-12 based on?  Basically it’s the IPC 2581 Revision B that’s been used for the general requirements.  Then the four additional standards in the IPC 258X series (IPC-2582, IPC-2583, IPC-2584, and IPC-2588) supply the XML details necessary for the range of data needed by industry.

The IEC/PAS 61182-12 is arranged into two main sections — Requirements and Content.  This separates the general information about XML and the types of schema used in the standard from the detailed requirements for specific data levels and content definitions.  There’s also extensive information at the end of the document on applicable IPC, ANSI, EDIF, ISO and DoD standards, as well as Annexes on the IPC-7351 naming convention for land patterns, the panel instance file, and a potential reference designator assignment for non-electrical items.

If you need any of these documents, you’ll want to use Document Center as your source.  With a consolidated collection of standards from around the world, Document Center offers you the opportunity to purchase, monitor and maintain standards from diverse sources at one location.

You can buy them 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 supplying customers like you from our Silicon Valley location since 1982.  Make us your Standards Experts!

ISO 17296 Series for Additive Manufacturing

September 11th, 2014

Additive manufacturing (sometimes known as 3-D printing) is a new and innovative way to do prototyping and even manufacture parts, tools and products.  In tandem with the development of this new technology, the need for standardization has resulted with the development of a new ISO 17296 series, Additive manufacturing – General principles.  It will eventually be a 4 document set, with ISO 17296-3 and ISO 17296-4 having just been released.

Because this is a new technology, early adopters are finding challenges regarding communication — for terminology, relevant test methods, and data exchange.  This can result in difficulties, including assessing the quality of the final products.  These are the issues the series is intended to address.

Let’s review the two documents one at a time:

ISO 17296-3, Additive manufacturing – General principles – Part 3: Main characteristics and corresponding test methods

This document is intended for use by machine manufacturers, feedstock suppliers, machine users, parts suppliers, and customers.  You’ll use Part 3 to specify your main quality characteristics, determine the appropriate test procedures, and set up your test and supply agreements.  It’s 22 pages in length, with primary sections on definition of and test methods for main characteristics and on parts and process testing.  There’s a 74 item bibliography to complete the document.

ISO 17296-4, Additive manufacturing – General principles – Part 4: Overview of data processing

This part of the series deals with functional requirements for the data that supports additive manufacturing.  You’ll be able to use it if you’re involved in manufacturing such equipment (including software), are involved in the development of CAD/CAE systems, develop reverse engineering systems, or need to compare the requested geometry with the actual end product.

Although the document is shorter than the Part 3 (only 14 pages), it provides the user with technical data required to understand the data formats used, how the data supports the additive process, and how to exchange that data successfully.   You’ll also want to review both the ASTM F2792, “Standard Terminology for Additive Manufacturing Technologies,” and the ASTM F2915, “Standard Specification for Additive Manufacturing File Format (AMF).”

When the series is fully issued, there will be an additional 2 documents:

ISO 17296-1, Additive manufacturing — General principles — Part 1: Terminology

ISO 17296-2, Additive manufacturing — General principles — Part 2: Overview of process categories and feedstock

If these standards apply to your business, you’ll need copies.  Head to Document Center’s webstore at www.document-center.com and order online.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  The publications are available in paper format, for pdf download and as part of our multi-user access service, Standards Online.  You’ll find many additional services that will help you maintain your standards collection as well!  Make us your Standards Experts.

New ISO 22004 – Guidance for ISO 22000 on Food Safety

September 10th, 2014

Food supply chain safety is in the news as products from around the world enter into the U.S. food supply at an increasingly faster pace.  Standardization is ideal for these types of issues, as it creates a baseline that both exporters and importers can agree on.  For food safety, the ISO 22000 provides basic requirements for organizations throughout the food chain.  And the new ISO 22004 standard provides you with clause-by-clause guidance on how to implement those requirements.  Titled “Food safety management systems – Guidance on the application of ISO 22000,” it’s available from Document Center now.

Originally released as a Technical Specification, the new 1st Edition (dated September 1st 2014) is a technical revision of the document.  Additionally, it assures the user that the information in the document will have permanent status as a standard (unlike the TS edition which by definition is only temporary).

Why would you want to use the ISO 22000 and it’s companion guidance document the ISO 22004?  If your company is involved anywhere in the food chain, you need a methodology of ensuring compliance with regulatory and other legal requirements.  You may also have customer requirements that the ISO 22000 system can address.  And you’ll have a way to reduce the risk to public health that food products can be associated with.

The ISO 22004 is organized into four primary informative sections:  Planning (Section 5), Implementation (Section 6), Verification (Section 7) and Improvement (Section 8).  This follows the general mantra of all quality systems: Plan, Do, Check, Act.  As noted above, within these sections, guidance is provided for each of the sub-clauses in the ISO 22000.

Another great feature of the new guidance document are the charts and text that show you the relationship of the various standards in the ISO 22000 series.  And there’s also general information on the structure of the ISO 22000 itself, providing you with both visual and textual support for the workflow and responsibilities you’ll need to implement this quality system.

ISO 22004 also provides you with tips on using outside resources, how the ISO 22004 relates to each of the 4 other ISO 22000 standards, and on using training and learning to provide improvement and motivation.  The document closes with a 16 item bibliography for further review.

Of course, if the ISO 22004 applies to your situation, you’re going to need a copy of the document.  Turn to Document Center Inc.  You can order online at our 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).  The ISO standards are available in paper format, for single-user pdf download, or as part of our multi-user access Standards Online service.

You’ll find Document Center has plenty of support services that will make it far easier to meet your documentation requirements for any quality program.  We’ve been working with customers like you since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New ASTM E10 2014 Edition – Brinell Hardness

September 9th, 2014

ASTM E10, “Standard Test Method for Brinell Hardness of Metallic Materials,” has just been updated.  If you use this standard, you’ll want to get your copy of the new 2014 Edition from Document Center Inc.  It’s available in paper format, for pdf download, and as part of our Standards Online subscription service for multi-user access.  The new update replaces the 2012 Edition, which is now obsolete.

Quite simply, the Brinell hardness test is an indentation test.  It provides you with a scale to use to measure the penetration of an indenter when it is “loaded” on a test specimen of a specific metallic material test piece.

The standard itself is a 32 page review of how to determine that Brinell hardness number for any metallic material.  It includes the requirements for a Brinell testing machine and the procedures you’ll use when performing Brinell tests.  There are also Annexes that cover verification of your Brinell testing machine, Brinell hardness standardizing machines, the Brinell hardness indenters and Brinell hardness test blocks.

The ASTM E10 is frequently referenced and widely used.  And it is co-numbered AASHTO T70.  Your committee in charge of the E10, ASTM Committee E28, brings the following update to your attention:  Changes to section 9.1.1.  So you’ll be able to review the changes from the last edition fairly easily.

You could also use the ISO 6506-1, ISO 6506-2, ISO 6506-3, and ISO 6506-4 (or the European adoptions of the same) for the Brinell test as well.  However, the convenience of the ASTM standard (all information in 1 document, plus a reasonable price tag) makes it more frequently referenced here in the U.S.

Purchase your copies of any and all of these standards 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).  We’ve been selling standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New ANSI/ESD S20.20 – ESD Protection for Electronic Parts

September 8th, 2014

ANSI/ESD S20.20 is one of Document Center’s best-selling ESD protection standards.  Titled “Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices),” it’s just been updated with the release of a new 2014 Edition.  The standard is part of the ESD Association’s series on the Development of Electrostatic Discharge Control Programs.  It specifically addresses how to set up and maintain an ESD control program for dealing with electronic parts and assemblies susceptible to damage from discharges greater than or equal to 100 volts Human Body Model (HBM) or 200 volts Charged Device Model (CDM).

As a user of the ANSI/ESD S20.20, you’ll be wondering what the changes are in this new 2014 Edition.  Here’s a listing of the areas the committee has brought to your attention in the Annex D concluding material of the new revision:

  • the Scope Section has been expanded to add voltages to applicable  isolated charged conductors
  • Section 6.1 has been modified
  • in Section 7.1, Product Qualification has been added as an element of the ESD Control Program Plan, resulting in the addition of a new Section 7.3 and further renumbering of other Section 7 subsections
  • Section 8.2 has been updated
  • Section 8.3 now has additional requirements and Table 3 has been modified
  • Section 8.4 on packaging has been reworded for clarity
  • Annexes A and B have also been updated

You’ll need a copy of the new standard and who better to turn to than Document Center Inc.?  Here you can find and order from a consolidated collection of over 450,000 unique titles (over current and obsolete 850,000 revisions tracked daily)!  Order 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 provide a wide range of services to help you keep your collection current as well as to help you identify newly-issued standards that may affect your business.  And we provide you with resources that help you identify the changes that are occurring to your documents as well!

We’ve been helping folks like you from our Silicon Valley location since 1982.  Make us your Standards Experts!